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Position Summary:

This position will be responsible for leading the development and implementation of a consolidated (global) regulatory strategy to secure and maintain market access for the assigned product through all development phases and through post-approval life-cycle management. The VP of Global Regulatory Affairs is also responsible for establishing and maintaining effective relationships with regulatory agencies, especially the FDA.

Primary Responsibilities:

* Anticipates global regulatory changes and develops proactive strategy accordingly.
* Develops regulatory strategies which will creatively position innovative products for expeditious review and approval at regulatory agencies.
* Review and approve regulatory submission documents and health authority communications.
* Interacts with regulatory agencies and ensures conversations and communications are focused, amicable and documented.
* Counsel and advise senior management / CMO on status of global regulatory affairs strategies and tactics, procedures and practices and provides critical risk assessments of the strategic alternatives for regulatory filings.
* Ensures compliance of regulatory strategies and submissions with current regulations and guidance.
* Assess project plans and timelines and ensures all projects are appropriately prioritized and key goals are met on time.
* Work to influence regulatory environment through active participation in conferences and industry / agency regulatory meetings, committees and trade associations.
* Develop and grow the regulatory department in keeping with the needs of the company, and coach and mentor department staff.

Qualifications:

* Collaboration & Teamwork: Advanced competence in collaboration & teamwork, communications influence, strategic agility, planning & organizing, driving results, and problem solving.
* Productivity/Organizing/Planning: Meets deadlines, demonstrates effective use of time, and handles multiple assignments simultaneously.
* Communication/Presentation Skills: Excellent ability to convey both written and verbal information effectively and efficiently and present information to all levels of audiences.
* Willingness to Acknowledge Areas for Growth: Understands need for growth and is receptive to constructive feedback.
* Leadership: Strong ability to establish and communicate clear visioning that team members willingly follow; provide information, knowledge and methods to realize that vision; coordinate and balance conflicting internal and external interests; ability to influence decision-making in a diplomatic manner. Able to navigate team smoothly through difficult situations.
* Strategic Thinking: Capable of thinking conceptually, imaginatively, systematically, and opportunistically to achieve company goals.

Education, Prior Work Experience, and Specialized Skills and Knowledge:

* Doctorate, Master's, or Bachelor's degree in a life science field (Biology, Chemistry, or Pharmaceutical sciences) with required years of experience.
* A minimum of 10 years Regulatory Affairs experience within small molecule or biologic drug development and registration activities.
* Successful submission, approval, and post-approval management of an NDA/MAA/NDS in multiple ICH regions.
* Full functional knowledge of regulatory requirements (Directives, Regulations, and Guidance) pertaining to the development and registration of drug products in multiple ICH regions.


Associated topics: cmo, donor, marketing, marketplace, policy, policies, presale, principle gift, public, stewardship

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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