Associate Director, Regulatory CMC
for sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. We must not repeat job title as heading. Must not include Job ID etc. Remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning, duplicated lines, application instructions. Also we must not create sections like Pay/Schedule/Benefits unless posting actually states them. The posting includes "Compensation The compensation package will be competitive and includes comprehensive benefits and an equity component. Salary Range: $180,000 - $210,500 (SF Bay Area). Salary ranges for non-California locations may vary." So we have Pay (salary range) and Benefits (mention of comprehensive benefits and equity component). Also maybe Schedule? Not mentioned. So we should include Pay and Benefits sections. Also we have About the role (the mission description). Responsibilities (Essential Functions). Requirements (the bullet list). Qualifications? The posting includes "Requirements" section with bullet points; also "Qualifications" maybe overlapping. The instruction says use headings for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to decide which sections to include based on content. The posting has a "Summary" paragraph describing role. That could be About the role. Then "Essential Functions" list -> Responsibilities. Then "Requirements" bullet list -> Requirements. There's also "Reports to: Executive Director, CMC Regulatory Location: San Carlos, CA / US Remote Work Arrangement: Remote". That's metadata; we can fold into a short
maybe under About the role or separate? Probably include as a short paragraph after About the role. There's no explicit Skills section separate from Requirements; but we could treat some items as Skills (computer software skills, interpersonal skills, strategic thinking, etc.) However we should not create thin sections. Better to keep Requirements as one section covering education, experience, skills. The instruction says prefer a few substantive sections over many thin ones. So we could have About the role, Responsibilities, Requirements, Benefits, Pay. That's five sections. No Qualifications or Skills separate. Ensure we don't create empty sections. We must preserve all substantive information; do not invent or summarize away detail. So we need to include all details from the posting except boilerplate. Let's extract content: Mission paragraph: "Join our Mission to Protect Humankind! Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance. WHAT We Do Is Every Bit As Important As HOW We Do It! Our Work Together Is Guided By Four Enduring Core Values RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making." That's a lot; we need to preserve it. It's basically About the role / company overview. Then "Summary A hands-on role providing both strategic and operational activities. This role develops and executes multi-product global regulatory CMC strategies for investigational products and leads the preparation and filing of regulatory CMC submissions. Manages interactions with Health Authorities for CMC topics. Provides regulatory CMC guidance to various cross-functional teams and ensures all applicable global regulatory requirements are considered and incorporated into product development. Conducts routine regulatory surveillance and communicates new/changing regulations." That's the role summary. Then "Essential Functions" list bullet points (each starting with a verb). We need to preserve each as
About the role
Join our Mission to Protect Humankind! Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance. WHAT We Do Is Every Bit As Important As HOW We Do It! Our Work Together Is Guided By Four Enduring Core Values RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.
Summary A hands-on role providing both strategic and operational activities. This role develops and executes multi-product global regulatory CMC strategies for investigational products and leads the preparation and filing of regulatory CMC submissions. Manages interactions with Health Authorities for CMC topics. Provides regulatory CMC guidance to various cross-functional teams and ensures all applicable global regulatory requirements are considered and incorporated into product development. Conducts routine regulatory surveillance and communicates new/changing regulations.
Reports to: Executive Director, CMC Regulatory Location: San Carlos, CA / US Remote Work Arrangement: Remote
Responsibilities
- Leads the preparation and review of CMC sections of global regulatory submissions, as well as the interactions and responses with regulatory agencies
- Member of technical development teams which require experienced interpretation of applicable EMA/FDA/ICH/Global regulations to ensure CMC compliance
- Defines CMC content (data and documentation) requirements for regulatory submissions and compiles/reviews this content for conformance with established requirements
- Provides CMC regulatory guidance to cross-functional teams and key stakeholders
- Manages regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations throughout development
- Leads projects with cross-functional teams and acts as the primary regulatory CMC contact for assigned products and projects
- Represents company in Health Authority meetings and leads or supports CMC preparation activities for meetings with Health Authorities on CMC related matters
- Stays abreast of current and evolving regulatory CMC requirements, applies this knowledge to assigned projects, and shares knowledge and experience with others to support their development
- Participates in the design, development and implementation of department strategies, providing recommendations in area of expertise
Requirements
- Bachelor’s Degree in a scientific discipline (e.g. Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices).
- Minimum 10 years of experience working in vaccine or biotech industry, or in a related field, or the equivalent combination of education and experience.
- Other combinations of education and/or experience may be considered.
- Prior experience preparing/authoring CMC DS sections:BLA highly preferred.
- Post-approval supplements/variations highly preferred.
- INDs/IMPDs.
- Prior development or manufacturing experience is a plus.
- Computer software skills (LIMS, SAP, TrackWise, Veeva will be used).
- Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency.
- Excellent interpersonal skills to communicate difficult concepts.
- Strategic thinking and strong problem-solving skills
- Collaborates and communicates in an open, clear, complete, timely, and consistent manner
- Strong sense of planning and prioritization, and the ability to work with all levels of management
- Advanced knowledge in regulatory (FDA, EMA, Health Canada and ICH) guidelines
Benefits
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Pay
Salary Range: $180,000 - $210,500 (SF Bay Area). Salary ranges for non-California locations may vary.
We must not include any extra text. Ensure no markdown fences. Output only