This is what you will do:

Position Summary

The Associate Director of Global Regulatory Affairs Chemistry, Manufacturing, and Controls (GRA-CMC) will be responsible for leading and providing global CMC regulatory support for the clinical and commercial product portfolio.

You will be responsible for:

Job Duties and Responsibilities

• Provide CMC support and advice for all internal activities related to manufacturing, development, control, and quality of commercial and clinical products.
• Independently lead, plan and manage assigned CMC programs, managing day-to-day delivery of plans and strategic activities for specific projects, including Life Cycle Teams and compliance of clinical and commercial products.
• Lead the development, preparation and submission of the CMC dossiers, supplements, and renewals for commercial products.
• Define and lead the development of high quality regulatory submissions.
• Manage, track, and assure accountability to global regulatory CMC commitments.
• 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. Investigates opportunities for regulatory innovation / promote the use of novel approaches and present CMC strategies and plans to management and appropriate core teams.
• Prepare teams for pre-submission meetings with regulatory authorities to reach agreement on complex CMC requirements. Interfaces directly with Health Authorities in 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 representatives of Regulatory Affairs including in-country regulatory leads, Manufacturing, Technical Services, Process Development, Quality and other key partners both internal and external to the company. Provide guidance and expertise on assigned GRA-CMC documents/projects. Participate in GMP inspections and lead GRA-CMC interactions.
• Partner with Manufacturing, Quality, Technical/Analytical Development and Research to develop the CMC CTD content and ensure compliance with global health authority requirements in preparation for licensure.
• 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.
• Mentor junior staff as needed.

You will need to have:

Essential Qualifications

• Relevant technical experience in biopharmaceutical or related industry experience with at least 6 years of Regulatory CMC experience; extensive experience should be in CMC of antibodies, protein therapeutics or other biological products. 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.
• Candidate is required to have a broad functional knowledge of pharmaceutical sciences / the Biopharmaceutical industry, with a clear understanding of drug development/commercial manufacturing of biopharmaceuticals.

Competencies

Accountability

Peer Relationships

Collaboration

Drive for Results

Change Agility

Perseverance

Decision Quality

Problem Solving

Informing

Time Management

Self-Awareness

People Agility

Date Posted

10-Sep-2024

Closing Date

24-Nov-2024Alexion 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. Alexion participates in E-Verify.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.