We are currently recruiting for a Senior Manager in our Regulatory Affairs department at our location in Morgantown, WV. In this role the Senior Manager will manage the preparation and review of new Abbreviated New Drug Applications and amendments and supplements to ANDAs for upper management review. Manage data and information including monitoring submission schedules for adherence to deadlines for Product Development and Chemistry, oversee internal and external reviews of new Abbreviated New Drug Applications, prepare amendment responses to FDA comment letters. This includes circulating comment letters for review and scheduling meetings to discuss response(s) and explain deadlines to other departments such as Product Development, Chemistry and Purchasing, manage pending ANDAs including ensuring that all regulatory requirements and/or commitments are met with respect to obtaining approval of new products and tracking changes to ensure that any additional information or revised documentation are submitted, manage ANDAs post-approval including performing thorough reviews of Annual Reports to ANDAs and serving as the sign-off to the 2252 form for upper management, manage employees by serving as a mentor and providing direction to direct reports including scheduling and distributing the regulatory workload, answering questions and providing guidance. Also monitor direct reports to ensure quality performance and provide performance feedback, provide regulatory advice and coaching on ANDA submissions, approval and post-approval process to Product Development, Quality Assurance, and Quality Control, review internal documentation such as change control information, method transfer packages, batch record documentation, validation protocols and reports, maintain current knowledge of regulations and other issues that affect products and the industry and perform other duties as assigned.
The preferred candidate will have a Bachelor’s degree with 9-12 years of experience in the Pharmaceutical industry or related field and 7-9 years of experience in Regulatory Affairs or a Master of Science or PharmD with 9-11 years of experience in the Pharmaceutical industry or related field and 6-8 years of experience in Regulatory Affairs.
However, a combination of experience and/or education will be taken into consideration. Must possess expert-level knowledge of the United States Pharmacopoeia, Title 21 of the Code of Federal Regulations and various FDA Guidances for Industry and have the ability to interpret these to apply to Mylan procedures. Must also possess expert-level knowledge of the regulatory process pertaining to drug development, registration, review and approval. Must possess knowledge of Mylan’s approach with regards to interactions with the FDA. Must possess strong analytical, organization, writing, communication skills. Must have the ability to multi-task and have meticulous attention to detail. Must possess strong computer skills and working knowledge of Microsoft Office Suite, Documentum, and Lotus Notes. Must be able to manage various projects and employees in order to meet submission deadlines.
At Mylan, we are not satisfied with anything less than being the best. As one of the world's
leading generics and specialty pharmaceutical companies, the key to our success starts with a relentless
drive to set the highest industry standards in everything we do. It takes exceptional people working together
to achieve excellence. As a team, we earn our customers’ trust and loyalty by placing a high premium on always doing the
right things in the right way.
Mylan offers competitive salary, excellent benefits and an environment conducive to professional growth and advancement.
Mylan is an Equal Opportunity Employer, M/F/D/V.
Opening Up a World of Opportunities
Mylan - 17 months ago