Global Head Regulatory Science Model Enabled Development Real World Evidence and Novel Endpoints
for section headings. Use - for any list of duties/requirements/benefits, and
for prose.
We must not repeat job title as heading. Do not put Job ID/requisition numbers as headings.
We must preserve all substantive information; do not invent or summarize away detail. Remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. The posting includes an EEO statement at end; we should remove that. Also "All compensation will be determined commensurate with demonstrated experience." That's boilerplate? It's a statement about compensation but not specific; we should not create Pay section. We can maybe include that sentence in a paragraph under Requirements or elsewhere? It's about compensation; but we are not to create Pay section unless posting actually states them. It does state compensation will be determined commensurate with experience, which is vague; we should not create Pay section. We could include that sentence in a paragraph under Requirements or maybe under a generic "About the role"? But we should preserve all substantive information; that sentence is substantive? It's about compensation but vague. The instruction says: "never emit a heading followed by filler/placeholder text (e.g. 'commensurate with experience', 'not specified', 'N/A', 'varies', 'TBD')". So we should not create a Pay heading with that text. However we could still include that sentence somewhere else as prose? The instruction says preserve ALL substantive information; do NOT invent or summarize away detail. If we omit that sentence, we are summarizing away detail. But we could include it in a paragraph under Requirements or maybe under a generic "About the role" section. However the instruction about Pay section: "never create Pay/Schedule/Benefits sections unless the posting actually states them." It does state compensation will be determined commensurate with demonstrated experience. That is a statement about pay, albeit vague. Should we create a Pay section? The instruction says never create Pay section unless posting actually states them. It does state something about pay, albeit vague. But then they also say never emit a heading followed by filler/placeholder text (e.g., "commensurate with experience"). So if we create a Pay section with that text, it would be filler/placeholder. So we should not create Pay section. But we need to preserve the info; maybe we can include that sentence in a paragraph under Requirements or elsewhere, not as a heading. That seems acceptable.
Similarly, Schedule: not mentioned. Travel: 10% travel expected. Could be considered schedule? Not exactly schedule; but we could include under a "Travel" subsection? Not required. The instruction only mentions Schedule section; we can ignore travel.
Now we need to parse the posting into sections:
- About The Job (maybe heading "About the role") includes paragraphs about mission, role description, about Sanofi.
- Main Responsibilities: list of responsibilities.
- Requirements: includes About You, Core Experience, Leadership Background, Technical and Regulatory Expertise, Education, Communication Skills, Strategic Thinking, Collaborative Leadership, Travel.
- Benefits: from Why Choose Us? includes: Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave.
We should turn those into a list? It's prose; we can keep as
. But instruction: Use
- for any list of duties/requirements/benefits. Benefits are not a list but we could make a list of items: health and wellbeing benefits, prevention and wellness programs, at least 14 weeks gender-neutral parental leave. Also "thoughtful, well-crafted rewards package". Could be list.
Better to treat Benefits as a list:
- Thoughtful, well-crafted rewards package recognizing contribution and amplifying impact.
- Wide range of health and wellbeing benefits including high-quality healthcare.
- Prevention and wellness programs.
- At least 14 weeks gender-neutral parental leave.
- Opportunities to grow talent and drive career via promotion or lateral move, domestically or internationally.
- Supportive, future-focused team.
But we need to preserve all substantive information; we should not lose any detail. The original also mentions "Bring the miracles of science to life alongside a supportive, future-focused team." That's a benefit. "Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally." That's another. "Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact." Another. "Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave." That's multiple.
We'll create a Benefits section with - items covering each distinct benefit.
Now Responsibilities: The posting has a block "Main Responsibilities" with several paragraphs each starting with a bolded phrase. We need to turn into a list. We'll extract each responsibility as a list item.
Let's parse:
"Provides Leadership and Strategic Vision: Accountable for organizational design, people development (supervising, coaching, mentoring), resource allocation (recruitment, retention, talent development, succession planning), and metrics for the expert unit. Demonstrates very strong leadership including influencing and negotiating skills, and conflict management and resolution. Capable of resolving and/or advising on very complex global organizational and regulatory/technical issues related to model-enabled development, regulatory real-world evidence and novel endpoints strategies. Demonstrates the knowledge and behaviors that model the Sanofi and GRA Values/Principles/Competencies. Establishes the team as a center of excellence for model-enabled regulatory strategies and submissions."
That's one responsibility.
"Develops and Implements Innovative Regulatory Strategies: Oversees the development of comprehensive regulatory strategy frameworks for Model-Enabled Drug Development across all development phases, in collaboration with Global Regulatory Leads (GRLs) and other parts of GRA. Leads regulatory validation projects (e.g., C-Peptide endpoint validation, iBox ) from concept to approval, ensuring alignment with R&D product project timelines. Assures that positive and collaborative relationships are developed with R&D partners (TMU, Clinical Development, Biostatistics) to achieve implementation of appropriate model-enabled regulatory / real world evidence regulatory strategies. Ensures that regulatory considerations are integrated early in development projects and that risks are identified, communicated, and mitigated as necessary."
Second.
"Leads Strategic Engagement with Regulatory Agencies: Oversees strategic negotiations and engagement with worldwide Regulatory Agencies, including directly with FDA and EMA, on emerging model development topics, MIDD approaches, real-world evidence and novel endpoints. Develops and implements health authority engagement plans to advance acceptance of innovative regulatory strategies. Assures appropriate representation of Sanofi at Agency meetings and scientific working groups; assures that contacts with Agencies are initiated and addressed in an effective and timely manner, whilst developing positive and favorable relationships with Agencies on cutting-edge regulatory science topics."
Third.
"Drives Knowledge Management and Capability Building: Provides vision and leadership for building specialized regulatory expertise in model-enabled development, real-world evidence approaches across the global GRA organization. Oversees the creation and dissemination of best practices, SOPs, training materials, and knowledge management platforms for such expertise and case studies. Partners with the Regulatory Capability and Learning Solution Lead to develop and deliver training curriculum and capability development programs. Monitors and communicates current Health Authorities thinking, regulatory trends, and paradigm shifts in model-enabled development, real world evidence and novel endpoints. Assures that the team takes a leadership role externally through participation in industry consortia, working groups, and professional associations."
Fourth.
"Ensures Excellence in Regulatory Submissions and Cross-Functional Collaboration: Oversees the preparation, review, and approval of model-enabled regulatory submissions, real evidence and novel endpoint validation packages to assure they meet appropriate quality standards and scientific rigor. Drives cross-functional project delivery efficiency through matrix collaboration with R&D counterparts. Assures that complex technical and regulatory issues related to modeling, simulation, and new endpoints are appropriately resolved with optimal solutions. Establishes clear governance and decision-making processes to enable efficient project execution and milestone achievement."
Fifth.
We'll make each a
- .
Now Requirements: The posting has "Requirements About You" then subheadings: Core Experience, Leadership Background, Technical and Regulatory Expertise, Education, Communication Skills, Strategic Thinking, Collaborative Leadership, Travel.
We need to turn into a list? The instruction: Use
- for any list of duties/requirements/benefits. So we should make a list of requirements. However the requirements are categorized; we could still list each bullet as a requirement item, preserving the subheadings maybe as part of the text. Could also keep subheadings as inside
- . But we must not create extra headings; we can keep them as part of the list item text.
We'll produce a
with each requirement as a - . We'll include the subheading text as part of the item.
Let's extract:
Core Experience:
- Minimum 10-15 years of regulatory affairs experience with demonstrated progression in regulatory roles and successful regulatory authority interactions.
- Direct experience with Model-Informed Drug Development (MIDD), pharmacometrics, modeling and simulation, and/or novel endpoint development is highly desirable.
- Proven track record of successful regulatory submissions involving advanced modeling approaches or innovative endpoints.
Leadership Background:
- Demonstrated leadership experience in building and developing specialized teams, including organizational design, people leadership and development (supervising, coaching, mentoring), recruitment, retention, talent management and succession planning.
- Experience establishing centers of excellence or expert units is highly valued.
- Ability to lead through influence in a matrix organization and drive cross-functional collaboration.
Technical and Regulatory Expertise:
- Strong knowledge of Model-enabled frameworks (e.g., FDA MIDD Pilot Program), regulatory pathways for novel endpoint validation, and key Agency thinking and trends in regulatory science innovation.
- Capable of resolving complex strategic technical and regulatory issues related to modeling, simulation, and endpoint development.
- Experience working with or for a Regulatory Health Authority is helpful but not essential.
Education:
- Bachelor's degree required.
- Advanced degree (Masters, Pharm D, PhD) in a quantitative science field (e.g., Pharmacometrics, Biostatistics, Pharmacology, Clinical Pharmacology, Translational Medicine, Computational Biology) or health sciences field, or equivalent is highly desirable.
Communication Skills:
- Demonstrated excellent communication and influencing skills internally and externally, with the ability to translate complex technical concepts for diverse audiences.
- Proven ability to build and maintain effective partnerships with health authorities, R&D functions, and external stakeholders including industry consortia.
Strategic Thinking:
- Demonstrated ability to assess regulatory risks and opportunities in emerging areas, develop pragmatic and innovative solutions that align with business objectives, and anticipate future regulatory trends.
- Demonstrated
for prose. We must not repeat job title as heading. Do not put Job ID/requisition numbers as headings. We must preserve all substantive information; do not invent or summarize away detail. Remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. The posting includes an EEO statement at end; we should remove that. Also "All compensation will be determined commensurate with demonstrated experience." That's boilerplate? It's a statement about compensation but not specific; we should not create Pay section. We can maybe include that sentence in a paragraph under Requirements or elsewhere? It's about compensation; but we are not to create Pay section unless posting actually states them. It does state compensation will be determined commensurate with experience, which is vague; we should not create Pay section. We could include that sentence in a paragraph under Requirements or maybe under a generic "About the role"? But we should preserve all substantive information; that sentence is substantive? It's about compensation but vague. The instruction says: "never emit a heading followed by filler/placeholder text (e.g. 'commensurate with experience', 'not specified', 'N/A', 'varies', 'TBD')". So we should not create a Pay heading with that text. However we could still include that sentence somewhere else as prose? The instruction says preserve ALL substantive information; do NOT invent or summarize away detail. If we omit that sentence, we are summarizing away detail. But we could include it in a paragraph under Requirements or maybe under a generic "About the role" section. However the instruction about Pay section: "never create Pay/Schedule/Benefits sections unless the posting actually states them." It does state compensation will be determined commensurate with demonstrated experience. That is a statement about pay, albeit vague. Should we create a Pay section? The instruction says never create Pay section unless posting actually states them. It does state something about pay, albeit vague. But then they also say never emit a heading followed by filler/placeholder text (e.g., "commensurate with experience"). So if we create a Pay section with that text, it would be filler/placeholder. So we should not create Pay section. But we need to preserve the info; maybe we can include that sentence in a paragraph under Requirements or elsewhere, not as a heading. That seems acceptable. Similarly, Schedule: not mentioned. Travel: 10% travel expected. Could be considered schedule? Not exactly schedule; but we could include under a "Travel" subsection? Not required. The instruction only mentions Schedule section; we can ignore travel. Now we need to parse the posting into sections: - About The Job (maybe heading "About the role") includes paragraphs about mission, role description, about Sanofi. - Main Responsibilities: list of responsibilities. - Requirements: includes About You, Core Experience, Leadership Background, Technical and Regulatory Expertise, Education, Communication Skills, Strategic Thinking, Collaborative Leadership, Travel. - Benefits: from Why Choose Us? includes: Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave. We should turn those into a list? It's prose; we can keep as
. But instruction: Use
- for any list of duties/requirements/benefits. Benefits are not a list but we could make a list of items: health and wellbeing benefits, prevention and wellness programs, at least 14 weeks gender-neutral parental leave. Also "thoughtful, well-crafted rewards package". Could be list.
Better to treat Benefits as a list:
- Thoughtful, well-crafted rewards package recognizing contribution and amplifying impact.
- Wide range of health and wellbeing benefits including high-quality healthcare.
- Prevention and wellness programs.
- At least 14 weeks gender-neutral parental leave.
- Opportunities to grow talent and drive career via promotion or lateral move, domestically or internationally.
- Supportive, future-focused team.
- items covering each distinct benefit. Now Responsibilities: The posting has a block "Main Responsibilities" with several paragraphs each starting with a bolded phrase. We need to turn into a list. We'll extract each responsibility as a list item. Let's parse: "Provides Leadership and Strategic Vision: Accountable for organizational design, people development (supervising, coaching, mentoring), resource allocation (recruitment, retention, talent development, succession planning), and metrics for the expert unit. Demonstrates very strong leadership including influencing and negotiating skills, and conflict management and resolution. Capable of resolving and/or advising on very complex global organizational and regulatory/technical issues related to model-enabled development, regulatory real-world evidence and novel endpoints strategies. Demonstrates the knowledge and behaviors that model the Sanofi and GRA Values/Principles/Competencies. Establishes the team as a center of excellence for model-enabled regulatory strategies and submissions." That's one responsibility. "Develops and Implements Innovative Regulatory Strategies: Oversees the development of comprehensive regulatory strategy frameworks for Model-Enabled Drug Development across all development phases, in collaboration with Global Regulatory Leads (GRLs) and other parts of GRA. Leads regulatory validation projects (e.g., C-Peptide endpoint validation, iBox ) from concept to approval, ensuring alignment with R&D product project timelines. Assures that positive and collaborative relationships are developed with R&D partners (TMU, Clinical Development, Biostatistics) to achieve implementation of appropriate model-enabled regulatory / real world evidence regulatory strategies. Ensures that regulatory considerations are integrated early in development projects and that risks are identified, communicated, and mitigated as necessary." Second. "Leads Strategic Engagement with Regulatory Agencies: Oversees strategic negotiations and engagement with worldwide Regulatory Agencies, including directly with FDA and EMA, on emerging model development topics, MIDD approaches, real-world evidence and novel endpoints. Develops and implements health authority engagement plans to advance acceptance of innovative regulatory strategies. Assures appropriate representation of Sanofi at Agency meetings and scientific working groups; assures that contacts with Agencies are initiated and addressed in an effective and timely manner, whilst developing positive and favorable relationships with Agencies on cutting-edge regulatory science topics." Third. "Drives Knowledge Management and Capability Building: Provides vision and leadership for building specialized regulatory expertise in model-enabled development, real-world evidence approaches across the global GRA organization. Oversees the creation and dissemination of best practices, SOPs, training materials, and knowledge management platforms for such expertise and case studies. Partners with the Regulatory Capability and Learning Solution Lead to develop and deliver training curriculum and capability development programs. Monitors and communicates current Health Authorities thinking, regulatory trends, and paradigm shifts in model-enabled development, real world evidence and novel endpoints. Assures that the team takes a leadership role externally through participation in industry consortia, working groups, and professional associations." Fourth. "Ensures Excellence in Regulatory Submissions and Cross-Functional Collaboration: Oversees the preparation, review, and approval of model-enabled regulatory submissions, real evidence and novel endpoint validation packages to assure they meet appropriate quality standards and scientific rigor. Drives cross-functional project delivery efficiency through matrix collaboration with R&D counterparts. Assures that complex technical and regulatory issues related to modeling, simulation, and new endpoints are appropriately resolved with optimal solutions. Establishes clear governance and decision-making processes to enable efficient project execution and milestone achievement." Fifth. We'll make each a
- .
Now Requirements: The posting has "Requirements About You" then subheadings: Core Experience, Leadership Background, Technical and Regulatory Expertise, Education, Communication Skills, Strategic Thinking, Collaborative Leadership, Travel.
We need to turn into a list? The instruction: Use
- for any list of duties/requirements/benefits. So we should make a list of requirements. However the requirements are categorized; we could still list each bullet as a requirement item, preserving the subheadings maybe as part of the text. Could also keep subheadings as inside
- . But we must not create extra headings; we can keep them as part of the list item text. We'll produce a
- with each requirement as a
- . We'll include the subheading text as part of the item. Let's extract: Core Experience: - Minimum 10-15 years of regulatory affairs experience with demonstrated progression in regulatory roles and successful regulatory authority interactions. - Direct experience with Model-Informed Drug Development (MIDD), pharmacometrics, modeling and simulation, and/or novel endpoint development is highly desirable. - Proven track record of successful regulatory submissions involving advanced modeling approaches or innovative endpoints. Leadership Background: - Demonstrated leadership experience in building and developing specialized teams, including organizational design, people leadership and development (supervising, coaching, mentoring), recruitment, retention, talent management and succession planning. - Experience establishing centers of excellence or expert units is highly valued. - Ability to lead through influence in a matrix organization and drive cross-functional collaboration. Technical and Regulatory Expertise: - Strong knowledge of Model-enabled frameworks (e.g., FDA MIDD Pilot Program), regulatory pathways for novel endpoint validation, and key Agency thinking and trends in regulatory science innovation. - Capable of resolving complex strategic technical and regulatory issues related to modeling, simulation, and endpoint development. - Experience working with or for a Regulatory Health Authority is helpful but not essential. Education: - Bachelor's degree required. - Advanced degree (Masters, Pharm D, PhD) in a quantitative science field (e.g., Pharmacometrics, Biostatistics, Pharmacology, Clinical Pharmacology, Translational Medicine, Computational Biology) or health sciences field, or equivalent is highly desirable. Communication Skills: - Demonstrated excellent communication and influencing skills internally and externally, with the ability to translate complex technical concepts for diverse audiences. - Proven ability to build and maintain effective partnerships with health authorities, R&D functions, and external stakeholders including industry consortia. Strategic Thinking: - Demonstrated ability to assess regulatory risks and opportunities in emerging areas, develop pragmatic and innovative solutions that align with business objectives, and anticipate future regulatory trends. - Demonstrated
- . But we must not create extra headings; we can keep them as part of the list item text. We'll produce a
- for any list of duties/requirements/benefits. So we should make a list of requirements. However the requirements are categorized; we could still list each bullet as a requirement item, preserving the subheadings maybe as part of the text. Could also keep subheadings as inside