Manager, Regulatory Affairs at Viatris Washington DC

Sunseeker Property Service; Washington (District of Columbia); In loco; USD 120.000 - 160.000; Tempo pieno

Vantaggi offerti da questo lavoro

Competitive benefits

Descrizione del lavoro

Viatris in Washington, DC seeks a Manager of Regulatory Affairs to lead submission activities for INDs, NDAs and ANDAs, coordinating with QA, QC, manufacturing, and R&D to ensure FDA compliance.

You will review documentation, provide strategic regulatory guidance, and manage cross‑department communications for timely filings. 4–7 years of related experience and strong English proficiency are required.

Competenze

• Bachelor's degree or equivalent required; science degree preferred.
• 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 across departments and communicate concepts.
• Ability to present to multiple departments and manage meetings.
• Ability to perform basic computations.
• Ability to follow prescribed procedures to solve routine problems.

Mansioni

• Review and approve submissions for IND, NDA, ANDA as applicable under FDA requirements.
• Interact with QA, QC, Manufacturing, R&D and others to gather information and documentation.
• Provide feedback on development and post-submission amendments.
• Recommend regulatory reporting mechanisms based on FDA and other authorities.
• Review technical documentation, product reports, specifications, and batch records for submissions.
• Offer regulatory guidance to other departments for planned changes.
• Research regulatory requirements for marketing applications across departments.
• Track commitments to FDA and ensure timely reporting.
• Prepare, review, and finalize amendments and supplements to product applications.
• Review internal documentation related to change control and validation reports.

Conoscenze

English proficiency

Cross-functional collaboration

Technical reading

Report writing

Formazione

Bachelor's degree or equivalent

Descrizione del lavoro

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

• 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.

Minimum Qualifications

• 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.

Benefits

• 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.

Equal Opportunity Employer

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.

Summary

SummaryLocation: Washington, District of Columbia, USAType: Full time