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Viatris · 1 day ago

Director, Global Regulatory Strategist -Allergy/Cardiovascular Portfolio

Washington, DC

Full-time

Onsite

Director/Executive

$112K/yr - $236K/yr

8+ years exp

Viatris is a healthcare company focused on empowering people to live healthier lives. The Director, Global Regulatory Strategist will develop regulatory strategies for Allergy and Cardiovascular products, ensuring compliance and optimizing project delivery while collaborating with various stakeholders.

BiotechnologyHealth CareLife SciencePharmaceutical

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

Qualification

Global Regulatory Affairs strategyRegulatory input to clinical developmentAllergyCardiovascular expertiseRegulatory Affairs Professional CertificationAdvanced writtenOral communicationProject management experienceComputer literacyWork autonomouslyEnglish proficiencyStrategic thinking

Required

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

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

Knowledge of Global applications for applications for Allergy and Cardiovascular products and product development an advantage

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

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

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

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