Reference #: R5643645 Viatris Specialty LLC

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 Director Regulatory Affairs Global CMC role will make an impact:

Key responsibilities for this role include:

Cultivates sustainable and effective relationships across a network of stakeholders, partners and customers to drive and establish aligned approaches to regulatory strategies and/or policies.

Interprets CMC regulatory requirements, develops strategies (including novel approaches), assesses risks and develops contingency proposals.

Uses technical and scientific knowledge in the preparation and analysis of global CMC submission documentation and maintenance of product compliance and management of CMC change control.

Ensures all CMC regulatory activities are executed effectively and efficiently, and in compliance with external regulatory requirements & internal quality procedures.

Serves as a liaison with regulatory agencies for specific topics and providing oversight for the fulfillment of agency commitments and providing responses to agency queries.

Presents and articulates issues for resolution, communicating regularly with key stakeholders to ensure alignment, providing consultation as a scientific/technical resource within the department/cross-functional and therapeutic teams for assigned projects, mentoring and sharing experience with colleagues.

Manages, leads and contributes significantly to Upjohn projects and initiatives within cross-functional project teams.

Serves on governance and steering committees.

Executes training related activities (e.g. compliance-related, HR policies) and individual development plans, participates in cross-disciplinary forums and learning opportunities, engages in Straight Talk & Listen exchanges, demonstrates and models adherence to all Viatris' behaviors and values, embraces and complies with Principles of Integrity.

Participates, as required, in pharmaceutical industry conferences or serves externally as a representative to pharmaceutical trade group advisory committees relevant to CMC functions.

Manages CMC responses in response to MedInfo queries.

May serve as the global CMC lead in Due Diligence exercises.

The minimum qualifications for this role are:

Minimum of a Bachelor's degree (or equivalent). A Master's degree (or equivalent) preferred. A minimum of 8-12 years pharmaceutical experience with relevant technical experience (Quality, Technical Services, R&D) and a minimum of 6 years pharmaceutical regulatory experience required. 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 5+ years.

Minimum of 5+ years people and/or project management experience, serving as a leader of matrixed and technical teams.

High level of knowledge of development & commercial activities and cGMP's to assess technical, scientific & regulatory merits of CMC information, commitments and data to lead teams and/or complex projects.

Extensive technical, functional, and industry knowledge in shaping project strategy, reducing regulatory burden and improving regulatory flexibility across global markets and diverse therapeutic areas. Independently capable of executing activities related to complex projects across all aspects of d ug development and commercial manufacturing product lifecycle.

Advanced understanding of current and emerging regulatory requirements and expectations, criteria for submission and approval globally, and experience in leading negotiations and interactions with regulatory authorities for projects and/or policy initiatives.

Possesses sound understanding of business expectations across partner lines, with proven ability to partner successfully with other Regulatory functions, Manufacturing and Supply Chain, Quality, Safety, Medical, Commercial, Legal and senior stakeholders to achieve objectives.

Advanced skills in written and oral communications (mandatory).

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

Demonstrated commitment and dedication to scientific and regulatory integrity and quality compliance.

Proven ability to deliver to time, cost and quality standards.

Demonstrated strategic thinking and ability to integrate strategies into actionable plans.

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 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.

Exact compensation may vary based on skills, experience, and location. The salary range for this position is $112,000 - $236,000.

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.

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Mylan offers competitive salary, excellent benefits and an environment conducive to professional growth and advancement. All qualified applicants will receive consideration for employment without regard to their disability or protected veteran status. Mylan is an Equal Opportunity Employer, Minorities/Female/Disabled/Veteran.Â