Responsible for the development and implementation of US and Canada 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 US and Canada regulatory requirements.
Assures that regulatory strategies defined within the GRPT, are effectively implemented and maintained in line with changing regulatory and business needs.
- Makes decisions and plans for operations (work flow, assignments, staff development) within area of responsibility with minimal direction. Sets strategy and leads cross-functional/multidisciplinary therapeutic teams and multidivisional initiatives. Operates independently, with recognition of when to consult departmental senior concerning risks.
- Assists in the management of the departmental budget, identifies and communicates budgetary needs to Operations and Finance, and identifies and projects current and future expenditures and business needs.
- Collects and analyzes issues/trends that affect business to identify and act on cross-organization or cross business opportunities. Uses knowledge of global marketplace, technology and business levels effectively.
- In absence of Director, is responsible for day-to-day operations, and departmental initiatives, which have significant impact on both internal and external customers. Manages direct reports and/or 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.
- Represents A&A on Global Regulatory Product Team (GPRT) and ADTs as appropriate. Advises on regional specific requirements and provides strategic input.
- Serves as Health Authority liaison and interfaces with Health Authority for meetings, teleconference, etc. Coordinates preparation of Health Authority meeting briefing packages
- Solid understanding of regulations and guidance of regulatory authorities, political and legal climate and industry practices to assist in meeting organizational goals. Possess and leverage broad industry knowledge. Coordinates and prepares submissions in line with Health Authority regulatory requirements and guidelines.
- Manages interface with Health Authority for key projects/issues, including direct negotiation with review division personnel. Coordinates and prepares submissions in line with Health Authority regulatory requirements and guidelines.
- Manages the preparation and review of regulatory submissions to assure effective presentation of data, complete and timely response to Health Authority during application review, and quality consistent with Health Authority regulatory requirements and guidelines.
- Manages direct reports and/or assists in the development, training, and mentoring of staff members.
- Required Education: Bachelor’s Degree (pharmacy, biology, pharmacology) or related life sciences
- Preferred Education: Relevant advanced degree is preferred. Certification a plus
- Required Experience: 8 years Regulatory, R&D or industry related experience
- 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
- Preferred Experience: 5 years in regulatory pharmaceutical affairs
- Strong leadership presence with prior management experience
- Experience developing and implementing successful global regulatory strategies
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Keyboard use (greater or equal to 50% of the workday)
Job Type: Experienced