Regulatory Affairs Specialist Cmc

1100 Mylan Pharmaceuticals Inc.

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.

Viatris empowers people worldwide to live healthier at every stage of life.

We do so via:

• Partnership – Leveraging our collective expertise to connect people to products and services.
• Access – Providing high quality trusted medicines regardless of geography or circumstance;
• Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and

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

Key responsibilities for this role include:

• Research information pertaining to marketing applications for other departments through the navigation of submissions and regulatory documentation system.
• Assess the appropriate regulatory reporting mechanism using health authority regulations, guidance documents and in-house policies and procedures upon review of Change Control Documentation.
• Maintain current knowledge of FDA regulations and guidance’s pertaining to changes to approved regulatory applications by utilizing the FDA website and remote participation or attendance at conferences.
• Prepare FDA required Annual Reports for Abbreviated New Drug Applications, New Drug Applications and Drug Master Files by scheduling and coordinating receipt of documentation/information, preparing cover pages describing changes made to the application, and tracking progress of their preparation. 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 system. Provide for management review.
• Assist departmental management in providing regulatory guidance to other departments (QA, QC, Manufacturing, Technical Services, etc.) for planned changes.
• Assist departmental management in keeping product marketing applications current by requesting revisions to technical documentation as part of the Annual Report preparation process.
• Manage the preparation and review of supplements to ANDAs, NDAs, and amendments to DMFs by scheduling and coordinating receipt of documentation/information, preparing cover pages describing changes made to the application, and tracking progress of their preparation. 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 system to ensure accurate reporting and tracking FDA acknowledgements and/or responses. Provide for management review. Monitor submission schedules for adherence to deadlines for change owner department (QA, QC, Manufacturing, Technical Services, Purchasing, R&D, Supply Chain etc.).
• Provide a critical detailed review of technical documentation including analytical procedures, specifications (product, excipient, etc.), manufacturing batch records, in-process specifications, etc. prior to FDA submission.
• Maintain departmental regulatory files/database and chronologies in good order.
• Track ANDA, NDA and DMF commitments made to FDA to ensure that these commitments are honored and reported in a timely manner.
• Assist in the preparation and review of Technical Transfer packages and ensure compliance with the registered application.

The minimum qualifications for this role are:

• Typically sitting at a desk or table. Intermittently sitting, standing, walking or stooping. Periodic travel is required. May be required to stand; walk; stoop; bend; kneel; and climb steps. May require use of hands and use of arms. Sedentary lifting requirements.
• Proficiency in speaking, comprehending, reading, and writing English is required.
• Must possess strong written and verbal communication skills, interpersonal skills, management skills, strong work ethic, consensus gathering skills and a working knowledge of Microsoft Office including Word, Excel and Powerpoint.
• Must possess knowledge of the United States Pharmacopoeia, Title 21 of the Code of Federal Regulations, various FDA Guidances for Industry, along with knowledge of the regulatory process pertaining to drug development, registration, review and approval would be desirable.
• Position functions autonomously and consults with departmental management on an as-needed basis.
• Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis. Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems.
• Must be proficient in spoken and written English. Ability to read and interpret general business documents. Ability to write routine reports and general business correspondence. Ability to work with peers and communicate basic concepts.
• Ability to calculate figures and amounts as necessary, such as percentages, proportions, volume, weight per unit volume, etc. Above average mathematical skills required.
• Minimum of a Bachelor's degree (or equivalent) and 0-2 years of experience. Minimum of a Bachelor of Arts / Bachelor of Science Degree in Science or health related field plus a minimum of 2 years of experience in the pharmaceutical industry or PharmD preferred. However, a combination of experience and/or education will be taken into consideration.
• Position is remote, but expected to be a normal office situation occurring during typical US business hours.

Exact compensation may vary based on skills, experience, and location. The salary range for this position is $41,000 - $93,000.

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.

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.