Director CMC Regulatory Affairs

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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 Director of CMC Regulatory Affairs is an experienced Regulatory CMC resource specializing in biotechnology products.
Your mission is to drive and perform regulatory activities linked to development, variations and/or international submissions of Marketing Authorisation Applications (MAAs) and BLAs.
As part of the Global regulatory CMC team, you define the CMC regulatory strategy in partnership with main stakeholders.
Moreover, you will be working in close collaboration with pharmaceutical development and industrial colleagues to provide for example, regulatory impact assessments on tech transfer, scale-ups or method changes as You will be responsible for the Module 3 (Quality) of our Marketing Authorisation for biologics.

Primary Responsibilities

• Lead and develop balanced risk-based global regulatory CMC strategies for all investigational and marketed products.
  Proactively contribute to and influence product development and life-cycle management.
  
• Effectively manage regulatory CMC aspects of projects including the preparation and submission of CMC sections of dossiers supporting clinical trial applications (i.e.
  IND/IMPD/CTA submissions), annual reports and marketing applications globally (i.e.
  US, EU, China, Eurasia, Brazil, etc.)
• Coordinate and contribute to the life cycle management (variations in EU, CBE, PAS, renewal of application) at the international level (i.e.
  US, Europe, Japan, Canada, China, etc.)
• Ability to represent RA CMC in global cross-functional Operations teams including Manufacturing, Quality, CMC/MSAT, Supply Chain, Product Strategy
• Leads the preparation of CMC documents in response to Health Authority or Agency requests for information, meeting briefing books to support Scientific Advice interactions
• Specific quality / regulatory activities include
• Management of Out Of Specification (OOS for batches under stability)
• Follow up of CMC commitments for the product under responsibility
• Review of Product Quality Review (PQR) production and regulatory review of PQR
• Contribute to Change Control procedures and evaluation:
  Regulatory impact analysis
• Compliance with the Quality Manual and Quality System of the Company
• Ensure documents meet regulatory requirements, standards and quality compliance

Education and Required Skills

• Graduate of a relevant bachelors science-related degree (e.g biotechnology, biology, pharmacy) required with 10+ years of relevant CMC/Regulatory CMC pharmaceutical industry experience.
  MS or PhD with 10+ years of relevant CMC/Regulatory CMC pharmaceutical industry experience desired.
  
• Prior direct, hands-on experience in the preparation and oversight of CMC submissions (INDs, IMPDs, NDAs and/or MAAs)
• Demonstrated knowledge of eCTD elements, structure and content; expertise in Module 3
• Strong knowledge and experience in CMC product development 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
• Knowledgeable in US, EU and key International regulatory guidelines
• 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 $200,000 - $235,000.
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 .