Sr Director CMC Regulatory Affairs
About Servier
With commercial stage products and a promising pipeline, we are a US-based affiliate of Servier Group, a unique global organization headquartered in France. Operating in more than 150 countries and governed by a non-profit foundation, we have multiple medicines approved in oncology, & other disease states globally. Additionally, we have accelerated our investments with an ambition to further establish ourselves as innovators in the Oncology space. Over half of our research and development efforts are specifically focused on delivering significant advances in targeted therapies to treat patient communities with unmet needs. At Servier, you will join a highly skilled team dedicated to bringing the promise of tomorrow to the patients we serve.
Role Summary
The Senior Director of CMC Regulatory Affairs for Biopharm products is an experienced and seasoned CMC Regulatory professional specializing in post-approval activities for Biopharm products. Experience in the development space would be valuable although not essential. Your mission is to drive and execute regulatory strategy for activities linked mostly to post-approval activities at global level. As part of the Global CMC Regulatory team, you define the CMC regulatory strategy in partnership with main stakeholders (eg: Industrial Operations, Quality Assurance, MSAT, etc). Moreover, you will act as the subject matter expert on post-approval activities for the Biopharma portfolio of the Company.
This is a high profile position with a lot of scope to influence the post-approval space for Biopharm products and beyond within the company.
Primary Responsibilities
- Lead and develop balanced risk-based global CMC Regulatory strategies for all the Company’s marketed products portfolio, proactively contributing to and influencing their life-cycle management
- Effective delivery and management of the CMC Regulatory aspects of projects including the preparation of all CMC Regulatory documents in support of post-approval life-cycle activities globally (i.e. US, EU, China, Eurasia, Brazil, etc.)
- Represent CMC Regulatory in global cross-functional Operations teams including Manufacturing, Quality, CMC/MSAT, Supply Chain, Product Strategy
- Acting as subject matter expert for post-approval activities for Biopharm products
- Coaching and mentoring of more junior members of the group.
- Matrix management of the wider regulatory team when the complexity of the project requires
- Specific quality / regulatory activities include
- Management of Out Of Specification (OOS) for batches under commercial stability
- Follow up of CMC commitments for the product under responsibility
- Regulatory review of Product Quality Reports (PQR)
- Contribute and lead CMC Regulatory input for Change Control procedures and evaluation: Regulatory impact analysis
- Compliance with the Quality Manual and Quality System of the Company
- Ensure all documents and regulatory strategies meet regulatory requirements, standards and quality compliance requirements
Education and Required Skills
- Graduate of a relevant bachelors science-related degree (e.g: biotechnology, biology, pharmacy, etc) required with 12-15+ years of relevant CMC/Regulatory CMC pharmaceutical industry experience. MS or PhD with 12-15+ years of relevant CMC/Regulatory CMC pharmaceutical industry experience desired.
- Prior experience in leading complex post-approval changes for Biopharm products, including matrix management of the wider regulatory team
- Demonstrated knowledge of eCTD elements, structure and content; expertise in Module 3
- Strong knowledge and experience in CMC product lifecycle managements (more specifically in the post-approval space) and in working collaboratively on internal/external/partnered cross-functional CMC teams
- Possess robust regulatory strategic acumen and thrive in a dynamic, multifaceted setting.
- Excellent critical thinking and problem-solving skills
- Well organized, scientifically driven, detailed oriented, pragmatic and open
- Excellent attention to detail with strong verbal and written business communication skills
- Expert knowledge in US, EU and key International regulatory guidelines related to CMC Regulatory topics
- Proficient in collaborating across global teams, prioritizing multiple tasks and projects, and consistently demonstrating discretion and professionalism
Travel and Location
- Minimal travel (less than 20%)
- Location: USA (remote east coast considered)
Servier’s Commitment
Servier is committed to modeling diversity, equity, and inclusion within the industry. We are dedicated to fostering an environment that maintains equitable treatment for all and we welcome applicants who are passionate, committed, and innovative individuals. We encourage candidates to apply to our open roles as we are always willing to consider experiences and skills beyond what is listed in the job description.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Salary Range
The salary range for this role is $245,000 - $279,000. An employee’s pay position within the salary range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, performance, and business or organizational needs. We may ultimately pay more or less than the posted range, and the range may be modified in the future. Employees in this position are also eligible for Short-Term and Long-Term incentive programs. Servier also offers a competitive and comprehensive benefits package that includes benefits such as medical, dental, vision, flexible time off (Servier provides unlimited sick time and flex time, and does not accrue time off), 401(k), life and disability insurance, recognition programs among other great benefits (all benefits are subject to eligibility requirements). For more information on our benefits, please visit this link.