Senior Director, Regulatory Affairs CMC at AstraZeneca

Posted in Other 11 days ago.

Location: Boston, Massachusetts





Job Description:

This is what you will do:



The Senior Director of Regulatory Affairs Chemistry, Manufacturing, and Controls (RA-CMC) will provide strategic as well as operational leadership of global CMC activities related to Cell & Gene Therapy (GCT) leading to successful registration and life-cycle management of unique and technologically complex products. May be a team leader and contributes to the leadership of RA-CMC.



You will be responsible for:



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

  • Provide and drive strategic and operational global CMC regulatory direction for both the RA-CMC group and/or assigned projects/products.

  • Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports.

  • Responsible for quality and timeliness of submissions. Interacts with other functions and external vendors, as necessary, in the preparation, review, and completion of documents for regulatory submissions.

  • Effectively plan, organize, supervise and/or conduct regulatory activities in close collaboration with leads from other functional areas. Assure compliance with regulations and with project team timelines and milestones.

  • Accountable for the development and implementation of innovative regulatory strategies to maximize the likelihood of regulatory success. Lead the development of proactive regulatory strategies supporting the portfolio.

  • Champion opportunities for regulatory innovation / promote the use of novel approaches and present CMC strategies and plans to management and appropriate core teams.

  • Lead engagement with internal and external partners including Health authorities.

  • Maintain oversight of the development and maintenance of internal Regulatory Affairs practices and procedures.




You will need to have:



  • Relevant technical experience in biopharmaceutical or related industry experience with at least 10 years of RA/RA-CMC experience, leading strategy development and strategy implementation in a cross-functional project team setting. Experience with diverse range of small molecule/vaccines/biologic products and dosage forms is desirable.

  • 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 as it relates to CGT products.

  • Demonstrated experience in strategic planning, preparing and leading global dossier submissions (e.g., US, EU, etc.) with in depth knowledge of current global regulations and guidance (e.g., US, EU, ICH, etc.) essential as they relate to the overall regulatory strategy.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
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