Senior Manager Regulatory CMC Strategy

10 Jul, 2022

Jobs

Senior Manager Regulatory CMC Strategy

Viatris
Remote

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 Senior Manager Regulatory CMC Strategy role will make an impact:

 

Key responsibilities for this role include:

  • Ensure regulatory conformance & consistency globally in compliance with external regulatory requirements & internal quality procedures.
  • Demonstrate regulatory knowledge & experience, balanced judgment, crisp decision-making, exemplary collaboration & business acumen, i.e., regulatory strategy development, regulatory submission quality, investigations, review of policy & quality standards.
  • Develop robust regulatory strategies, leveraging both technical & regulatory knowledge, to mitigate risks.
  • Prepare & deliver of high-quality CMC regulatory submissions & submission management plans for global regulatory agencies.
  • Execute using regulatory policies and implementation of policies and operational processes for delivering the product portfolio.
  • Serve as CMC representative on a core project(s), manage project activities, assess regulatory risks & develop plans to develop global regulatory strategies for programs in accordance with regulatory, scientific & technical criteria.
  • Manage regulatory issues, maintain submission information in relevant CMC systems, track regulatory commitments & timelines for specific projects/products/markets with minimal supervision.
  • Present and articulate issues for resolution, communicating regularly with key stakeholders to ensure alignment and providing consultation as a scientific/technical resource for assigned projects, mentoring and sharing experience with colleagues.
  • Author and/or coordinate CMC activities for new registrations, post approval changes, renewals, annual reports and line extensions to meet filing requirements. Coordinate and contribute to responses to Agency queries and perform quality review of regulatory CMC submissions.
  • Serve as a technical and scientific resource and provide guidance for completion of difficult and complex projects.
  • Prioritize and independently complete assigned workload appropriately.
  • Develop effective relationships with local and global internal partners, i.e., R&D; Quality; Country & Regional Regulatory Leads; other CMC lines.
  • Develop relationships with regulatory authorities to improve Viatris’ regulatory success.
  • Execute training related activities (e.g. compliance-related, HR policies) & individual development plans, participate in cross-disciplinary forums and learning opportunities, engage in Straight Talk & Listen exchanges, demonstrate and model adherence to all Viatris’ behaviors & values, embrace & comply with Principles of Integrity.
  • Manage and contribute to CMC-related projects, initiatives & actions.
  • Participate, as required, in pharmaceutical industry conferences or serve externally as a representative to pharmaceutical trade group advisory committees relevant to CMC functions.
  • Mentor colleagues within focused area of expertise.

 

The minimum qualifications for this role are:

  • Minimum of a Bachelor’s degree (or equivalent) required.
  • A minimum of 8 years pharmaceutical experience with relevant technical experience (Quality, Technical Services, R&D) and a minimum of 3 years pharmaceutical regulatory experience required.  However, a combination of experience and/or education will be taken into consideration.
  • Mandatory hands-on CMC authoring experience (initial registrations or post-approval variations) – Minimum of 2+ years
  • Sufficient level of knowledge and solid understanding of the development and commercial activities and cGMP’s required to assess technical, scientific and regulatory merits of CMC information, commitments and data to lead teams and/or project(s).
  • Advanced technical, functional, and industry knowledge to shape strategic direction of assigned project(s), reduce regulatory burden and improve regulatory flexibility commensurate with business needs.
  • Advanced knowledge of regulatory requirements and expectations, criteria for submission and approval globally and experience of interactions with regulatory authorities for projects.
  • Updating, interpreting, and applying global and regional CMC guidelines, along with the ability to contribute to global regulatory strategies by proactively discussing with partners.
  • Emerging awareness of new scientific or manufacturing technology.
  • Sound understanding of business expectations across divisions
  • Sound understanding and advanced knowledge of the principles, practices and concepts of regulatory CMC/ policy/ publishing disciplines and a working knowledge of the principles, practices, concepts and operations in other relevant disciplines.
  • 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. Normal office situation.
  • 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.

Learn more here

 

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Job posted: 2022-07-10