Director, Global Regulatory Affairs CMC

This is what you will do:

The Director of Global Regulatory Affairs Chemistry, Manufacturing, and Controls (GRA-CMC) will be responsible for developing and implementing global CMCregulatory strategy leading to successful registration and life-cycle management of unique and technologically complex products.  May lead individual teams (people manager).

You will be responsible for:

• Lead the development and implementation of global CMC regulatory strategy supporting both clinical and commercial products.  Recognized CMC expert serving as primary project leader responsible for the development of CMC regulatory strategies, submissions and compliance activities. 

• Provide and drive strategic and operational global CMC regulatory direction and documentation for assigned projects/products covering initial registrations and approval/post approval activities. 

• Primarily accountable for assigned CMC programs, managing daily delivery of regulatory and strategic activities, including initial registrations and post-approval changes, portfolio growth initiatives, and ongoing compliance of commercial products in the portfolio.

• Develop proactive regulatory strategies for global CMC product lifecycle management, with limited oversight.  Independently resolve complex issues and manage regulatory risks and ambiguous situations within project teams.  Champion opportunities for regulatory innovation / promote the use of novel approaches and present CMC strategies and plans to management and appropriate core teams.

• Initiate, prepare and lead teams for CMCmeetings with regulatory authorities to reach agreement on complex CMC requirements.  Interfaces directly with Health Authoritiesin order to discuss and define regulatory applications (Quality Module, Responses, and Commitments).  May act as CMC representative in formal meetings and teleconferences with regulatory authorities. 

• Partner with and serve as the GRA-CMC representative within cross-functional project teams including Regulatory Affairs, Manufacturing, Technical Services, Process Development, Quality and other key partners both internal and external to the company.  

• Participate in GMP inspections and lead GRA-CMC interactions.

• Propose new/revised policies and recommend standard interpretation of global regulations.  Maintain an awareness of global legislation and assess its impact on the business and product development programs.

• Contribute to local and regional regulatory initiatives promoting a culture aligned with company values and which supports compliance, innovation and talent development and retention

• Accountable Team Leader manages and develops junior staff (as appropriate).

You will need to have:

• Relevant technical experience in biopharmaceutical or related industry experience with at least 8 years of GRA-CMC experience.  Experience with diverse range of small molecule/vaccines/biologic products and dosage forms is desirable. Other relevant experience in the pharmaceutical industry, for example in (Bio)Pharmaceutical or Analytical Development, Quality Control, Manufacture, also considered.

• Education:  BA/BS degree (or equivalent) in a scientific discipline, MS or Ph.D. preferred.

• Strong written and oral communication skills; comfortable communicating with and building relationships with numerous stakeholders in a cross functional environment.

• Candidateis required to have a broad functional knowledge of pharmaceutical sciences /the biopharmaceutical industry, with a clear understanding of drug development/commercial manufacturing of biopharmaceuticals.