Manager, Regulatory Affairs

Mylan Pharmaceuticals Inc.

Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.

We have been included on number of award lists that demonstrate the impact we are making.

Every day, we rise to the challenge to make a difference and here’s how the Manager, Regulatory Affairs role will make an impact:

 

Key responsibilities for this role include:

• Review and approve when appropriate for submission Investigational New Drug Applications (IND), New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA), NDA or ANDA supplements, NDA or ANDA Annual Reports in accordance with FDA requirements. This duty includes the review of documents, interacting with multiple departments (QA, QC, Manufacturing Purchasing, R&D, etc.) which provide information and documentation, utilizing the change control database to ensure accurate reporting and tracking FDA acknowledgements.
• Review and provide appropriate feedback in the development and post submission by requesting revisions to technical documentation as part of the Annual Report and amendment/supplemental preparation process.
• Recommend the appropriate regulatory reporting mechanism using FDA regulations and other Health Authorities, guidance documents and in-house policies and procedures upon review of Change Control Documentation.
• Provide a necessary regulatory review of technical documentation, product reports, analytical procedures, product specifications, manufacturing batch records, in-process specifications, etc. for FDA submission.
• Provide departmental management regulatory guidance and input and guidance to other departments (QA, QC, Manufacturing, etc.) for planned changes. Research information pertaining to marketing applications for other departments through the navigation of submissions and regulatory documentation system.
• Recommend procedures to track commitments made to FDA to ensure that these commitments are honored and reported in a timely manner.
• Prepare, review and finalize submission of amendments and supplements to product applications.
• Review internal documentation such as change control information, method transfer packages, batch record documentation, validation protocols and reports as appropriate.
• Maintain current knowledge of FDA regulations and guidance’s pertaining to changes to approved regulatory applications by utilizing the FDA website and other resources.

The minimum qualifications for this role are:

 

• Minimum of a Bachelor's degree (or equivalent) and 4-7 years of experience. Science degree, preferred. However, a combination of experience and/or education will be taken into consideration. 
• Must be proficient in spoken and written English. Ability to read and interpret business and/or technical documents.  Ability to write comprehensive reports and detailed business correspondence.  Ability to work with groups of people such as other departments and communicate known concepts.  Ability to present to a group of departments.
• Ability to perform computations such as percentages, ratios, and rates.
• Ability to solve practical problems through standardized solutions that require limited judgment.  Ability to follow prescribed and detailed procedures to solve routine problems.
• May be required to stand; walk; stoop; bend; kneel; and climb steps. May require use of hands and use of arms. 
• 2-3 days per week in the Washington, DC office.
• Proficiency in speaking, comprehending, reading and writing English is required.

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Viatris is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.