Director, Global Regulatory Strategist -Allergy/Cardiovascular Portfolio

Viatris • Washington, DC

2d

About The Position

Mylan Institutional 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: 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. This posting supports ongoing hiring needs and may be used to consider candidates for upcoming opportunities. Every day, we rise to the challenge to make a difference and here’s how role will make an impact:

Requirements

• Minimum of a Bachelor's degree (or equivalent).
• A minimum of 8 years in regulatory and a minimum of 5 years of global regulatory experience (US/EU) required.
• A combination of experience and/or education will be considered.
• Global Regulatory Affairs strategy, with hand-on authoring experience (initial registrations or post-approval variations) - Minimum of 5+ years
• Elevated level of knowledge of development & commercial activities to assess clinical, scientific & regulatory merits of information, commitments and data to lead teams and/or complex projects, with a focus on Allergy and Cardiovascular products.
• Extensive clinical and industry knowledge in shaping project strategy, reducing regulatory burden & improving regulatory flexibility across global markets and diverse therapeutic areas.
• Independently capable of executing activities related to complex projects across all aspects of drug development and commercial manufacturing product lifecycle.
• Advanced understanding of current and emerging regulatory requirements & expectations, criteria for submission & approval globally, & 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, Clinical, Non-Clinical, Safety, Medical, Commercial, R&D, Legal and senior stakeholders to achieve objectives.
• Advanced skills in written & oral communications (mandatory).
• Computer literacy with Microsoft Office Suite and Documentum-based applications.
• Prior experience (minimum of 5+ years) managing projects and matrixed teams and/or serving as a people manager.
• Ability to participate in interactions with regulatory authorities to respond to requests either directly or in conjunction with Regulatory Affairs personnel.
• Demonstrated commitment and dedication to scientific and regulatory integrity.
• Proven ability to partner successfully with Regulatory, Commercial, Safety, Medical, other partner lines and senior stakeholders to achieve objectives.
• Proven ability to deliver to time, cost and quality standards.
• Demonstrated strategic thinking and ability to integrate strategies into actionable plans.
• With a strong track record of demonstrating extensive depth and breadth of regulatory strategy, enabling a leadership role to be assumed which requires minimal supervision.
• Position functions autonomously, with minimal supervision.
• Ability to read and interpret comprehensive and intricate research documents.
• Ability to author 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.
• Proficiency in speaking, comprehending, reading and writing English is required.

Nice To Haves

• An advanced Scientific Degree (Ph.D., Pharm.D., M.D., M.Sc.) and/or a business qualification (DMS, MBA) may be an advantage but is not essential.
• Knowledge of Global applications for applications for Allergy and Cardiovascular products and product development an advantage.
• Allergy and Cardiovascular therapeutic areas an advantage.
• Regulatory Affairs Professional Certification, preferred.

Responsibilities

• Developing Global/Regional regulatory strategies and implementation plans for Allergy and Cardiovascular complex projects/products including novel, product enhancement and post approval products
• Ensuring regulatory contributions achieve the objectives in the strategy, meet agreed standards, while optimizing overall project delivery time and probability of a successful outcome.
• Providing regulatory input to clinical development programs, risk/benefit assessments and for target label development.
• Ensuring an aligned regulatory position is reached and communicated for all key issues for assigned projects/products, and that these regulatory positions supporting the business are championed, communicated, and executed on time to the required quality standards.
• Serving as a member of the Product Labelling Team to contribute to the development and update of the CCDS and contribute to the development and maintenance of local labels, as appropriate.
• Cultivate sustainable and effective relationships across a network of stakeholders, partners and customers to drive and establish aligned approaches to regulatory strategies and/or policies.
• Ensuring regulatory plans are monitored, progress is communicated to Senior Management and any risks (from emerging technical data, changing internal objectives or external impacts) are mitigated.
• Direct activities to ensure the required documentation is prepared to a high standard and that all regulatory requirements and/or commitments are met for obtaining Marketing Authorizations.
• Author sections of the dossiers, as applicable.
• Developing and maintaining constructive working relationships with Health Authority contacts.
• Organize, lead or participate in meetings with regulatory agencies, as appropriate.
• Ensure quality expectations are met for all submissions and Health Authority interactions.
• Work closely with other Regulatory team members to develop and ensure adherence to consistent and appropriate processes, systems, working practices, shared learnings and quality standards.
• Understanding current global and regional evolving regulations and guidelines with the ability to assess these requirements' impact on products/projects.
• Using strong experience and examples, where appropriate, to influence the evolving regulatory environment through Health Authority engagement, partners and trade associations.
• Supporting regulatory Due Diligence activities for business development opportunities.
• Provide input to and adhere to departmental budget.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level