This is what you will do:

Position Summary

The Manager of Global Regulatory Affairs Chemistry, Manufacturing, and Controls (GRA-CMC) will support project teams and complex projects for compiling global CMC submissions and responses to regulatory agency inquiries for clinical and commercial products.

You will be responsible for:

Job Duties and Responsibilities

Independently manage multiple projects and submissions.  Accountable for assigned CMC programs, managing day-to-day delivery of plans and strategic activities for specific projects as needed.  Lead the planning, coordination, and manage the development, preparation and submission of the CMC registration dossiers, post approval management/supplements, and renewals.Develop proactive regulatory strategies for global CMC product lifecycle management, with limited oversight.  Present CMC strategies and plans to both management and the appropriate project teams.Support and potentially lead project teams for CMC submissions.Create and maintain project plans to ensure clarity of deliverables and timing.Constantly monitor and evaluate GRA-CMC team's progress towards meeting milestones and timelines, through active communication and review of pertinent information.Track regulatory action items through to completion and help drive timely decisions, and facilitate active communication and information flow between team members.Provide feedback to management on project progress / scope changes / risks and impact to timelines.Provide interpretive analyses of regulatory guidance documents, regulations, or directives that impact CMC submissions and plans for assigned countries.Prepare responses to health authority questions and comments; prepare briefing packages as assigned.  May act as CMC representative in formal meetings and teleconferences with regulatory authorities.Work closely with representatives of Regulatory Affairs, Manufacturing, Technical Services, Process Development, Quality and other key partners both internal and external.Ensure that the quality and content of CMC documentation is complete and complies with applicable regulations and regulatory/scientific guidelines and in accordance with Alexion’s strategic initiatives and policies.Ensure that appropriate CMC documentation is filed and archived in designated systems.Creates and contributes to the development of internal policies, processes and procedures supporting the progression and maintenance of the portfolio.

You will need to have:

Essential Qualifications

An experienced regulatory professional with a minimum 5 years related experience, including at least 3-5 years in a Regulatory, Quality or Compliance function. Other relevant experience in the pharmaceutical industry, for example in (Bio)Pharmaceutical or Analytical Development, Quality Control, Manufacture, also considered.Bachelor’s degree in a relevant scientific discipline.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

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.