Specialist, Global Regulatory Affairs (GRA) Brands Chemistry, Manufacturing & Controls (CMC)

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: 

• Access – Providing high quality trusted medicines regardless of geography or circumstance;

• Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and 

• Partnership – Leveraging our collective expertise to connect people to products and services. 

Every day, we rise to the challenge to make a difference and here’s how the Specialist, Global Regulatory Affairs (GRA) Brands Chemistry, Manufacturing & Controls (CMC) role will make an impact:

Key responsibilities for this role include:

• Leverages the support of more experienced colleagues, country guidance documents/regulations, and Viatris GRA systems and tools, to develop robust CMC submission strategies.

• With some supervision, authors high quality CMC content for global regulatory submissions in Viatris Brands CMC templates, aligned to ICH CTD requirements.

• Ensures compliance to internal procedures and external regulatory requirements.

• Presents and articulates issues for resolution, communicating regularly within GRA and with other key stakeholders.

• Maintains regulatory information in relevant CMC systems, tracks regulatory commitments & timelines for specific projects/products/markets.

• Collaborates in responding to Health Agency queries.

• Prioritizes and completes assigned workload.

• Develops effective relationships with local, regional and global internal partners, i.e., R&D; Quality; Global, Country & Regional Regulatory Leads; other Regulatory Science/CMC teams.

• Executes training related activities and individual development plans, participates in cross-disciplinary forums and learning opportunities, demonstrates and models adherence to all Viatris’ behaviors and values, embraces and complies with Principles of Integrity.

• Contributes to CMC-related projects, initiatives and actions.

• Performs other duties as assigned.

The minimum qualifications for this role are:

• Minimum of a Bachelor's degree (or equivalent) in Pharmacy or related scientific discipline and 0-1 year of experience.  A combination of experience and/or education will be taken into consideration. 

• A Master's degree (or equivalent) preferred.

• Has an understanding of regulatory requirements & expectations, criteria for submission & approval globally.

• Has emerging awareness of new scientific or manufacturing technologies

• Advanced skills in written & oral communications (mandatory).

• Computer literacy with Microsoft Office Suite and Documentum-based applications.

• Some project management experience

• Ability to demonstrate commitment and dedication to scientific and regulatory integrity and quality compliance.

• Position functions with some supervisory and/or peer support.

• Ability to read and interpret comprehensive and intricate research documents.  Ability to write scientific reports and technical correspondence.  Ability to work with executives and communicate abstract concepts.   Ability to present to a high level of the organization and groups outside of the organization.

• Ability to solve equations, apply technical mathematical concepts, and perform complex computations. 

• Ability to solve problems with complex variables through non-standardized solutions that require independent judgment and analysis.  Ability to draw inferences and use deductive reasoning with no prescribed procedures to solve complex problems.

• Typically sitting at a desk or table. May be required to stand; walk; stoop; bend; kneel; and climb steps. May require use of hands and use of arms.  Sedentary – Minimal handling of light materials, lifting up to 10 lbs. Periodic travel may be required. Owing to the global nature of the position, occasional work outside of core working hours may be required.

• Proficiency in speaking, comprehending, reading and writing English is required.

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.

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.