Senior Manager, Regulatory Affairs - CMC at Alexion Pharmaceuticals, Inc.
Posted in Professional Services 16 days ago.
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Location: Boston, MassachusettsJob Description:
Alexion Pharmaceuticals, Inc.
Alexion is an Equal Opportunity/Affirmative Action Employer.
Req ID: 11830
Job Category: Regulatory Affairs
Location: Boston, MA
Posting Date: February 8, 2018
Attention: If you are a current Alexion employee, please apply via Alexion's internal Life & Career portal. Note that you will need to be connected to the VPN if you are applying away from the office.
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The Senior Manager, of Regulatory Affairs Chemistry, Manufacturing, and Controls (RA-CMC) will manage complex projects for compiling global regulatory CMC strategy and submissions and in support of Alexion's commercial and investigational products. In addition this role will manage the collection and submission of GMP documents for global clearances and accreditations of manufacturing, testing, and packaging/labeling sites.
Job Duties & Responsibilities
- Independently manage multiple projects and submissions in support of Alexion's commercial and investigational products.
- Plan, coordinate, and manage the development, preparation and submission of the CMC sections of Alexion's registration dossiers, supplements, and renewals for commercial products. Dossier preparation will include new country submissions and post-approval changes.
- Develop proactive regulatory strategies for global CMC product lifecycle management, with limited oversight. Present CMC strategies and plans to Alexion management and appropriate core teams.
- 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.
- At least 8 years related experience in a scientific discipline with additional technical / project education or training; with a minimum of 5 years of experience in Regulatory and/or, Regulatory-CMC.
- Education: Bachelor's degree in relevant scientific discipline.
- 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.
Boston, MA, United States
Some opportunities happen only once in a lifetime – like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.
Alexion is a multinational biopharmaceutical company with approximately 2,500 dedicated employees serving patients in more than 50 countries through the innovation, development, and commercialization of life-changing therapies. As the global leader in complement biology, Alexion developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG).
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