Manager, Global Regulatory Affairs - CMC - Vaccines

Sanofi (US); Swiftwater (Monroe County); On-site; USD 100,000 - 130,000; Full time

Job summary

Join a leading global healthcare company as a Manager in Global Regulatory Affairs - CMC for Vaccines. In this role, you will develop regulatory strategies and manage CMC aspects throughout the product lifecycle, ensuring compliance and timely submissions. You will collaborate with cross-functional teams, providing regulatory guidance and support for vaccine development. This position offers opportunities for growth, competitive rewards, and a chance to make a significant impact on public health.

Benefits

Health and wellness programs

Parental leave

Opportunities for growth and development

Competitive rewards and benefits

Qualifications

• 4+ years in pharma manufacturing, QA, or QC.
• 4+ years CMC regulatory experience.

Responsibilities

• Develops regulatory CMC strategy for assigned projects/products.
• Manages contacts with regulatory agencies related to CMC issues.
• Prepares and coordinates CMC documents for license applications.

Skills

Communication

Organizational Skills

Regulatory Knowledge

Education

Bachelor's degree

Master’s degree

Tools

MS Word

Excel

PowerPoint

Job description

Manager, Global Regulatory Affairs - CMC - Vaccines

View more categories View less categories Discipline Regulatory Affairs ,CMC Hours Full Time Contract Type Permanent Experience Level Experienced (non-manager)

Job Title: Manager, Global Regulatory Affairs - CMC - Vaccines

Location: Swiftwater, PA or Morristown, PA

About the Job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

The Manager, Global Regulatory Affairs - CMC has the responsibility of one or several products/valences in the Reg CMC Vaccines group. They will also develop the product(s) CMC submission strategy and is responsible for managing all the regulatory CMC aspects throughout the life cycle of the product(s) they have in charge from development (where necessary) through post licensure.

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

Main Responsibilities:

The CMC Manager develops the regulatory CMC strategy for the project(s)/product(s) assigned. This involves:

• Compiling all relevant information necessary to support the best regulatory CMC strategy for registration of a new vaccine or a license update in all concerned countries.
• Developing and maintaining the Regulatory CMC Strategy Document (GCRSD) when applicable and keeping it updated throughout the project/product lifecycle. Ensuring coordination with Clinical Development, Product Development, Marketing, and CMC functions.
• Contributing to the Global Regulatory Product Strategy (GRPS) via the GRT and/or GRTL.
• Participating in change control assessments (CCRs) for major markets of any proposed changes by IA, preparing RSID and implementation plans with a global perspective.

Regulatory Submissions:

Responsible for Modules 2 and 3 of the CTD for marketing applications, amendments, variations, and routine license maintenance activities. Supports all product phases in development. Coordinates creation of module 2.3 and module 3 CTDs for License Applications as approved.

• Implements regulatory strategies via relevant CMC submissions.
• Prepares and coordinates CMC documents supporting license applications (CTD, IND, BLA, etc.) and other submissions.
• Authors, reviews, and edits CMC components of regulatory submissions.
• Ensures timely preparation of CMC components per procedures and templates, and coordinates final submissions.
• Anticipates delays, identifies root causes, and proposes corrective actions or alternatives.
• Reports progress and issues proactively and timely.

Planning/Coordination:

Works with GBU / GRTLs / SMEs for planning and coordinating CMC activities from initiation to approval, including:

• Prioritization and detailed planning.
• Developing CMC regulatory objectives and timelines.
• Providing timelines for critical activities.
• Documenting and following up in Veeva RT system.

Health Authority (HA) Contacts and Communications:

Manages contacts with regulatory agencies or third parties related to CMC issues.

• Notifies relevant internal teams of critical issues.
• Discusses and negotiates with authorities, documents interactions.
• Coordinates meetings and prepares materials with GRT.

HA Commitments & Documents:

Tracks and manages CMC-related requests and commitments from authorities.

HA Inspection Support:

Supports inspection preparations and activities as needed.

Regulatory Guidance:

Provides CMC regulatory advice to project teams and other functions, including:

• Sharing regulatory requirements and guidance documents.
• Providing training on policies and procedures.

About You

• Bachelor's degree in a relevant discipline; Master’s preferred. 4+ years in pharma manufacturing, QA, or QC.
• 4+ years CMC regulatory experience.
• Experience with filings, responding to health authority comments.
• Ability to work in a matrix environment, strong organizational skills.
• Effective communication skills to influence teams and authorities.
• Solid regulatory knowledge, understanding of AI’s industry impact is a plus.
• Background in drug development, manufacturing, or testing.
• Proficient in MS Word, Excel, PowerPoint.
• Experience with global project teams.

Why Choose Us?

• Join a team bringing science to life.
• Opportunities for growth and development.
• Competitive rewards and benefits.
• Health and wellness programs, parental leave.

Sanofi Inc. and affiliates are Equal Opportunity employers, committed to diversity and inclusion. All qualified applicants will be considered without regard to legally protected characteristics.