Manager, Regulatory Affairs

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 lifes 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 heres 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 guidances 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 Bachelors 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.