Manager, Global Regulatory Affairs - CMC - Vaccines

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 the 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 the document updated throughout the life of the project/product.  Ensuring the coordination with the different areas concerned : Clinical Development, Product Development, Marketing and CMC related functions.

• Contributing to the Global Regulatory Product Strategy (GRPS) as requested via the GRT and/or GRTL

• Participating and performing change control assessment (CCRs) (for major markets) of any necessary changes proposed by IA and preparing the RSID and implementation plan with a global view for the impacted product(s).

Regulatory Submissions: 

Responsible for Modules 2 and 3 of the CTD for applicable marketing applications, related amendments or variations and all routine license maintenance activities, as well as providing support for all applicable products in all phases of development.  For new marketing applications, the CMC Manager / PFP coordinates the creation of the module 2.3 and module 3 Common Technical Documents (CTD) for License Applications wherever filing is approved via the RAP, Global Project Team or otherwise.

• Executes and implements the defined regulatory strategy and/or GCRSD via relevant CMC submissions.

• Prepares and coordinates the creation of the CMC documents in support of complete license applications (CTD, IND, BLA, etc.) and other regulatory submissions for regulatory authorities and/or third parties.

• Authors CMC related documents/summaries, coordinates reviews and approvals, and provides editorial review for all CMC components of regulatory applications and submissions.

• Ensures preparation of the CMC components of the submission within pre-defined schedules in accordance with relevant RA procedures, tools, and templates, and coordinates the final submissions.

• Anticipates any delays in pre-defined submissions, finds the root cause, sets-up corrective action plan and/or proposes alternate solutions.

• Regulatory CMC Manager / PFP is independently responsible for reporting on progress and specific issues pertaining to project/product CMC responsibilities.  Communication should be proactive and timely.

Planning/Coordination: 

The Regulatory CMC Manager will work jointly with GBU / Global Regulatory Team Leads (GRTLs) / Subject Matter Experts / etc. for the planning and coordination of regulatory CMC activities relating to projects/products from initiation to approval, which include:

• Detailed plan prioritization and coordination of activities

• Developing CMC related regulatory objectives and target dates.

• Providing timelines for critical CMC regulatory activities to be incorporated into the project plan.

• Appropriate documentation / follow-up in Veeva RT (RA document manage system).

Health Authority (HA) Contacts and Communications: 

The Regulatory CMC Manager / PFP manages contacts with regulatory agencies or third parties related to CMC issues.

• Responsible for the notification / communication to the most appropriate individuals within the company based upon the topic criticality of  the issues to be addressed.

• Discusses and negotiates issues with regulatory authorities/third parties; and communicates, documents and archives information for the organization.

• Responsible for notification to relevant functional areas and impacted project team(s) regarding communications/feedback from regulatory authority.

• Sets up the necessary meetings with regulatory authorities/third parties and co-ordinates the preparation of the pre-reads and the presentations, in connection with the GRT.

Health Authority (HA) Commitments & Documents: 

Responsible for timely and accurate tracking of CMC related regulatory authority requests and commitments and to manage completion.

Health Authority (HA) Inspection Preparation/Support and Other RA Process Development Support: 

The Regulatory CMC Manager might:

• Participate and provide support in all applicable inspection preparation activities and inspections, as requested.

• Provide project/product-related input and resources towards the development and implementation of new RA systems, procedures, and/or tools.

Regulatory Guidance: 

Responsible for providing regulatory CMC advice and guidance to Project/Product Team members and other functional areas on regulatory matters. This could include:

• Providing information from regulatory requirements documents and other appropriate guidance documents.

• Providing training and education/guidance on regulatory policies, procedures and other regulatory documents in collaboration with Regulatory Operations.

About You

• Earned Bachelor's degree in a relevant discipline required, Masters degree preferred with 4+ years of pharmaceutical industry experience, ideally in manufacturing, quality assurance or quality control

• 4+ years CMC regulatory experience

• Experience with preparation & management of filings; ensuring thoroughness, accuracy, timeliness of CMC dossiers & responses.

• Experience responding to Health Authority comments and issues related to submissions.

• Experience working in a matrix environment and excellent people skills are required.

• Strong organization skills

• Concise, informative and persuasive communication skills to impact project teams and HA interactions

• Strong Regulatory knowledge and demonstrated application of requirements is very helpful

• Foundational understanding of Artificial Intelligence and impact on industry is highly preferred

• Strong background in drug development, manufacturing, or testing

• Proficient in MS Word, Excel, PowerPoint

• Demonstrated ability to work successfully on global project teams.

Why Choose Us?

• 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 it’s 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.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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