VP of Regulatory Affairs

Job Description

Description

Company Overview:

A biopharmaceutical company developing and delivering innovative therapies in critical care and infectious disease. Our approved treatments are indicated to address high unmet medical needs for serious conditions, and our investigational therapies are in development for patients fighting drug-resistant pathogens.

Summary of Position :

The VP, Head of Regulatory Affairs is a key leader accountable for the development and execution of comprehensive global regulatory strategies for the development programs and marketed products. This leadership role will play a critical part in shaping the regulatory pathway and ensuring compliance with global regulatory requirements. The role is also responsible for the implementation of clinical/regulatory strategies in collaboration with other functional leaders in the organization.

This role has high visibility across the Leadership Team and has a significant impact towards the success and achievement of the business and corporate goals.

Responsibilities :

• Responsible for the management and leadership of Regulatory Affairs including Reg Strategy, Reg CMC, Reg Ops, Advertising and Promotion and Labeling
• Provide strategic direction for the regulatory affairs team
• Provide regulatory oversight and guidance to project teams on compliance matters, health authority requirements, clinical study design issues, logistics and operational recommendations for product development
• Accountable for the development and implementation of global regulatory strategies throughout development of programs (e.g., regulatory meeting materials, INDs, NDA/BLAs, CTAs, MAAs, responses to regulatory inquiries, IND Safety reports, etc.)
• Facilitate problem-solving and drive decision making with project teams
• Collaborate with other functions to plan and execute an effective regulatory strategy in alignment with the overall development and/or lifecycle plan
• Manage the regulatory strategy on a continuing basis, including effectively communicating deliverables to project team and proactively drive teams and external partners to meet the designated timelines for deliverables
• Effectively communicate the regulatory strategy, risks, mitigations and overall plans to the project teams and Executive Leadership team as required
• Establish and maintain excellent relationships with regulatory agency personnel. Respond to request for additional data, organize and manage participation in meetings, and prepare internal teams for regulatory interactions. Negotiate with regulatory authorities regarding company submissions
• Monitor regulatory publications to keep apprised of new or changing regulatory developments and potential strategic impact

Experience & Education:

• Bachelor's degree in a scientific discipline; Advanced degree (PharmD or PhD) in a scientific discipline is preferred
• Minimum 15 years in life sciences industry related experience with at least 10 years of direct Regulatory Affairs experience in leading successful NDA submissions/ approvals

Skills and Abilities:

• Knowledge of the current US regulations. Global regulatory experience is a plus.
• Experience with CTD format and content regulatory filings
• Current knowledge and understanding of GxPs (GCPs, GLPs, GMPs) and ICH guidelines as well as FDA, international, and, if applicable, local regulations
• Proven track record of successful regulatory submissions and approvals (FDA, EMA, etc.) for drugs
• Knowledge of and broad experience with regulatory procedures and legislation for drug development product registration, line extension and license maintenance in the EU and the US
• Excellent communication, negotiation, and interpersonal skills with the ability to influence and collaborate effectively across functions and levels, both internally and externally
• Highly effective as a mentor and coach, and able to attract, develop, inspire, and retain key talent
• Experience managing complex schedules and priorities in dynamic environments; ability to conform with shifting priorities, demands and timelines through analytical and problem-solving capabilities
• Familiar with e-publishing systems for preparing regulatory submission is a plus

TSP Talent Solutions and our customers are affirmative action/equal opportunity employers (Minorities/Females/Veterans/Disabled)