The Associate Director Regulatory Affairs Area & Affiliate defines and implements regulatory strategies and priorities in conjunction with Global Regulatory Lead and the GRPT, as appropriate. Ensures application of established policies and best practice regulatory standards within its region for all filings, maintenance of existing product registrations and agency interactions. Acts independently or under supervision. Has division level influence, responsibility, is a key opinion leader and an expert resource within AbbVie. May serve as primary regulatory contact with Health Authority. Assists Regulatory staff by outlining regulatory strategy and providing data needed to support filings, responses to Health Authorities inquiries, and registration maintenance.
- 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
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity and affirmative action employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic. If you would like to view a copy of the company’s affirmative action plan or policy statement, please email CorpJat_ABV@abbvie.com.