Lead, R&D Document Standards & Integrated Services

Main Responsibilities

• Define and own the long-term strategy for all document standards, template governance, and submission-ready authoring across the global organization encompassing all R&D Authoring functions.
• Standardize the preparation of documents intended for regulatory submission, ensuring alignment with regional and global Health Authority requirements across all submission types (e.g., NDA, MAA, IND, BLA, CTD).
• Establish and lead a singular governance and quality control model for R&D encompassing document templates, including review cadence, approval workflows, and access controls to ensure quality at the source.
• Develop, version, and maintain Operational Procedures (OPEs) for template governance in alignment with GxP and regulatory standards.
• Drive continuous optimization of the template library to ensure efficiency, compliance, and alignment with evolving Health Authority requirements.
• Define and enforce clear template ownership, accountability, and maintenance responsibilities across various functions within R&D – including clinical, non-clinical, pharmacovigilance, regulatory and CMC.
• Represent the Submission & Document Services Platform in governance committees and cross-functional initiatives, advocating for process optimization and standardization.
• Lead the ongoing rationalization and harmonization of document templates across R&D ensuring a lean, well-governed, and consistently maintained library of documentation required for dossier submission.
• Establish and sustain a single source of truth for formatting standards, ensuring consistent visual identity and style application across all R&D dossiers and authoring platforms.
• Partner with Digital in the management of style assets (including but not limited to .dot files and toolbar plug-ins) to ensure seamless author access and adherence to formatting standards.
• Create, maintain and monitor dashboards to track operational metrics and provide ongoing visibility to leadership on program health and performance.
• Develop and maintain standardized document preparation workflows specifically designed to meet submission requirements across multiple regulatory jurisdictions (e.g., FDA, EMA, PMDA, Health Canada, etc.).
• Implement submission readiness checklists and quality review processes within Global Submissions management to ensure documents meet formatting, content, and structural requirements prior to dossier compilation.
• Partner with eGSM lead, Digital and DDAI to evaluate, recommend, and implement tools and technologies that improve the efficiency and quality of document authoring and submission preparation, including AI-enabled and automation solutions.
• Maintain awareness of the evolving regulatory technology landscape and proactively identify opportunities to modernize authoring and submission workflows.
• Evaluate and champion technology solutions that support end-to-end submission readiness, including document assembly, publishing, and electronic submission tools (e.g., eCTD).

Stakeholder Collaboration & Change Management

• Strategically lead cross-functional stakeholders — including Clinical, Nonclinical, PSPV, M&S / CMC, and GRA — to ensure process alignment, integration, adoption of the new model.
• Build and maintain strong relationships across the R&D authoring community to drive sustained onboarding and adoption of standardized processes and tools.
• Design and deploy change management strategies and training programs that support authors through process and technology transitions.
• Develop communication strategies to ensure stakeholders are continuously informed about standards updates, available resources, and process improvements.
• Facilitate collaboration among global teams, including the Hyderabad Hub and Digital organization partners.
• Partner with Regulatory Operations and submission project managers to align document preparation timelines with submission planning milestones.

About You

• Education: Bachelor’s degree or equivalent degree in regulatory affairs, sciences, related areas of study and/or relevant experience. Master's degree, preferred.
• Experience: Minimum of 8 years of experience in pharmaceutical document management or regulatory operations, with demonstrated background in process optimization, continuous improvement methodologies, and cross-functional program leadership.
• Soft, digital and technical skills: Proficiency with document management software and tools, such as electronic document management systems (EDMS), Adobe Acrobat, Microsoft Office Suite, Veeva Vault RIM. Understanding of eCTD submission standards required; understanding of regulatory Information Management systems is highly valued.
• Other: Excellent verbal and written communication skills to effectively collaborate with multiple levels in the organization; Strong decision-making abilities with analytical approach to problem-solving; Ability to manage simultaneous priorities and coordinate complex projects in a matrix environment; Demonstrated capacity to identify process inefficiencies and propose practical solutions; Strong analytical skills with the ability to translate data into actionable insights; Adaptability and flexibility to work in a fast-changing, innovation-driven environment; Ability to manage simultaneous priorities and coordinate complex, multi-workstream programs in a global matrix environment; English language proficiency required (verbal and written).