Director, Global Regulatory Affairs CMC

The Director of Global Regulatory Chemistry, Manufacturing, and Controls (GRA-CMC) will develop and implement global CMC regulatory strategy leading to successful registration and life-cycle management of unique and technologically complex products.

Accountabilities

• Lead the development and implementation of global CMC regulatory strategy supporting both clinical and commercial products.
• 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.
• Lead assigned CMC programs, managing 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 regulatory strategies for global CMC product lifecycle management, with limited oversight. Independently resolve complex issues and manage regulatory risks. Champion opportunities for regulatory innovation / promote the use of novel approaches and present CMC strategies and plans to management teams!
• Initiate, prepare, and lead teams for CMC meetings with regulatory authorities to reach agreement on complex CMC requirements. Collaborate with Health Authorities to discuss and define regulatory applications (Quality Module, Responses, and Commitments).
• 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

Essential Skills/Experience

• BA/BS degree (or equivalent) in a scientific field
• At least 10 years experience in biopharmaceutical or related industry experience with experience in regulatory or quality
• Experience with diverse range of small molecule/vaccines/biologic products and dosage forms is desirable. Other proven experience in the pharmaceutical industry, for example in (Bio)Pharmaceutical or Analytical Development, Quality Control, Manufacture, also considered
• Strong written and communication skills

Desirable Skills/Experience

• Education: MS or Ph.D. preferred.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, you will enjoy the vibe, entrepreneurial spirit, and autonomy of a leading biotech combined with the security and investment of a global pharma. Here, every one of us works to the highest standards to protect our patients, our people, and our planet. You will be supported to define the career you want to build, encouraged to take ownership, develop new abilities, skills, and expand what you can do.

Ready to make an impact? Apply now!

Date Posted

14-Nov-2024

Closing Date

23-Feb-2025Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com.<