Director, Global Regulatory Strategy US & Canada
Director, Global Regulatory Strategy US & Canada Key Responsibilities:
- Responsible for products with multiple driver indications for a product within a Therapeutic Area and supports the Global Regulatory Lead (GRL, Director), in the development & execution of the regulatory strategy.
- Serves as expert resource and may represent Global Regulatory Strategy (GRS) with initiatives, bringing expertise and insights to projects sponsored by functions like Quality Assurance, Operations, or Regulatory Affairs in product recall and recall communication process.
- Effectively collaborates with FDA including Senior Agency personnel. Collaborate with regulatory authorities during the development and review process to ensure submission approval.
- Advise/influence senior level customers who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and others such as Commercial Demonstrates negotiation skills, problem solving skills and builds consensus.
- May also lead direct reports with people management responsibility (performance, merit, development).Leads cross-functional therapeutic teams.
- Develops and/or actively mentors individuals. Makes decisions and plans for operations (work flow, assignments, staff development) within area of responsibility. Acts independently or under supervision of a GRL, Director, Senior Director.
- Provides strategic input and technical mentorship on the preparation of all regulatory submissions consistent within US and Canada regulatory requirements and guidelines.
- Builds and develops product positioning strategies and integrates regulatory consideration into the corporation's global product entry and exit in collaboration with partners within RA, ADT and other disciplines. Assesses issues and strategies for regulatory/business implications using knowledge of global marketplace.
- Anticipates emerging issues across a product lifecycle and develops solutions and works in partnership across functions to coordinate management of critical regulatory issues. Reviews and approves disseminated information to minimize regulatory exposure and preserves confidentiality of product information.
- Leads teams actively to operate in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP).
- Required Education: Bachelor's degree (pharmacy, biology, chemistry, pharmacology), or related life sciences.
- Preferred Education: Relevant Master's degree Certifications a plus
- Required Experience: Required Experience: 10+ years Regulatory, R&D, or industry related experience. Five plus years in quality systems. Strong clinical and scientific foundation, with shown ability to understand and interpret study data and technical information.
- Preferred Experience:7 years in US and Canada pharmaceutical regulatory affairs, preferred experience in more than one region
- Skill Set: Extensive experience working with government Agencies and Health Authority personnel. Experience working in a complex and matrix environment.
- Strong communication skills, both oral and written. Proven 7-10 years in a leadership role with strong management skills.
- Proven experience developing and implementing successful global regulatory strategies. Strong leadership presence with prior management experience.
- Consistently demonstrates effective written and verbal communication skills in written and oral channels both within Regulatory and across the Enterprise. Consistently able to deliver meaningful messages effectively without compromising important business relationships.