- Represents department and participates in meetings with US Commercial. Represents Regulatory on Global Regulatory Product Team (GPRT) and ADTs as appropriate. Advises on region specific requirements and provides strategic input.
- Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
- Ensures departmental training and compliance with established regulations, guidance’s and SOPs related to regulations for self and direct reports. Manages direct reports and assist in the development, training and mentoring of staff members
- Effectively presents pertinent information to appropriate cross-functional groups. Effectively delivers difficult messages to commercial organization without damage to relationships
- Establishes solid relationships with management and key stakeholders fostering mutually beneficial interactions and exchange.
- Assesses R&D programs against region specific regulatory requirements
- Influences internal customers on Regulatory /Health Authority issues including commercial, public affairs, clinical development, legal, and others who contribute to regulated communication
- Supervises the preparation and review of regulatory submissions consistent within a geographic region, Regulatory requirements and guidelines and assures complete and timely response to Health Authorities during application review
- Serves as Health Authority liaison and interfaces with Health Authorities for meetings, teleconference, etc. Coordinates preparation of Health Authority meeting briefing packages
- Demonstrates excellent negotiation skills, problem solving skills and builds consensus. Functions independently in negotiation and decision-making for project related issues that have cross-functional impact.
- Required Education: Bachelor’s degree (pharmacy, biology, chemistry, pharmacology) or industry related
- Preferred Education: Advanced Degree a plus. Certifications a plus
- Required Experience: 7 years Regulatory, R&D or industry related experience
- Proven skill at implementing successful global regulatory strategies
- Experience working in a complex and matrix environment
- Preferred Experience: 2-3 years’ experience in pharmaceutical regulatory activities
- Experience interfacing with government regulatory agencies
Travel: Yes, 20 % of the Time
Job Type: Experienced