VP Regulatory Affairs
- Reference ID: Med004
- Type: Permanent
VP Regulatory Affairs, has primary responsibility for the development and implementation of regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development. This individual demonstrates the ability to combine knowledge of scientific, regulatory & business issues to enable development and commercialization of products that are developed, manufactured or distributed to meet relevant regulatory requirements.
- Area of responsibility has significant regulatory impact and possibly significant impact to the Company overall.
- Serve as the primary corporate liaison / contact with domestic and/or international regulatory agencies (e.g., FDA Investigators, Notified Body Auditors) regarding the Medefil’s quality management system)
- ISO Management Representative.
- Host FDA, Canada Health, European Union, ISO audits
- Ensure that all departments are aware of new or evolving pharmaceutical / device regulations – FDA, Canada Health, European Union, and ISO.
- Manage the Customer Complaints Program:
- Medical Device Reports as appropriate to the FDA, Health Canada and the European Union.
- Post market surveillance monitoring, reports including product complaints and MDRs.
- Prepare and present to management tracking metrics for RA area activities, customer complaints/ MDRs.
- Manages interface with Health Authority (FDA) for key projects/issues, including direct collaboration with review division personnel
- May also serves as primary liaison and interfaces with FDA for meetings, teleconferences and coordinates preparation of FDA meeting briefing packages and responses
- Demonstrates effective communication skills in written and oral channels both within Regulatory and across the organization
- Advise internal customers who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and others such as Commercial
- Demonstrates excellent negotiation skills, problem solving skills and builds consensus
- Able to deliver challenging messages effectively without compromising important business relationships
- Establishes solid relationships with management and key stakeholders fostering mutually beneficial interactions
- Operates independently, with recognition of when to consult management
- Makes decisions and plans for operations (work flow, assignments, staff development) within area of responsibility with minimal direction
- Assists in the development, training, and mentoring of staff members
- Encourages innovation and holds employees accountable for delivering on their goals; recognizes, mentors, rewards and recommends promotion for staff members based on their performance, results, and development
- Coordinates, prepares and/or supervises the preparation and review of regulatory submissions consistent within US regulatory requirements and guidelines and assures complete and timely response to Health Authorities during application review
- Ensures application of established policies and best practice regulatory standards for all US product registrations
- Demonstrates solid understanding of current US regulations and guidance, political and legal climate and industry practices to assist in meeting organizational goals
- Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas and is generally recognized as a resource & leads the department as a subject matter expert (SME) for Regulatory
- Uses problem solving skills to separate and combine tasks into efficient workflow and effectively/creatively solve complex and difficult problems
- Presents pertinent regulatory information to appropriate cross-functional areas.
- Provides input into the budget, identifies and communicates budgetary needs, and identifies current and future expenditures and business needs
- Provide budgetary input into the use of contractors and consultants.
- Operates in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP)
- Work is focused on operational plans in support of strategic goals.
Experience and Education
- Bachelor’s Degree (pharmacy, biology, pharmacology) or related life sciences
- Relevant advanced degree is preferred
- Certification a plus
- 10 plus years Regulatory, R&D or Industry-related experience
- 8 years in injectable pharmaceutical regulatory affairs
- Extensive experience interfacing with government Agencies and Health Authority personnel.
- Experience working in a complex and matrix environment
- Demonstrated success in negotiation skills, strategic thinking, and credibility within the organization
- Strong communication skills, both oral and written
- Proven skill at implementing successful US and Canada regulatory strategies; global regulatory experience is a plus