The Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) Combination Products and Medical Devices is responsible for combining knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured, or distributed to meet required legislation. Develops, actively mentors and supervises a team of global regulatory professionals who develop strategy for development and marketed products, and managers the content of global regulatory dossiers. Has influence and responsibility and is a key leader and a driver of regulatory policy and strategy. Influences the development and changes of regulations and guidance. Interfaces with outside regulatory agencies and trade associations and provides executive management with regulatory metrics and information. Individual may plan, direct, coordinate and control regulatory affairs activities related to products worldwide.
- Leads a team of global regulatory professionals who develop strategy for development and marketed products including combination products and medical devices, and manages the content of global regulatory dossiers. Advises internal personnel on regulatory strategies
- Key internal leader and driver of regulatory policy and strategy. Provides executive management with meaningful regulatory measurements and regulatory opinion
- Advises management of the effect of current, newly finalized or proposed laws, regulations, guidelines and standards and on advisory committee recommendations.
- Influences the development of regulations and guidance. Advances the organization’s goals by participating and taking leadership roles in professional associations, industry and trade groups as appropriate for assigned projects
- Provides direction and guidance to exempt specialist and/or supervisory personnel who exercise significant latitude and independence in their assignments, may be asked to evaluate performance of and assist in career development planning for subordinates
- Develops, communicates and builds consensus for operating goals that are in alignment with the company.
- Provides leadership to organizational staff by communicating and providing guidance towards achieving department objectives.
- Recommends modifications to the structure of organizational units or a centralized functional activity subject to senior management approval. Develops, communicates, and builds consensus for operating goals that are in alignment with the company. Creates immediate to long-range plans to carry out objectives established by executive management
- Makes decisions regarding work processes or operational plans and schedules in order to achieve the program objectives established by senior management
- Makes decisions and provides guidance for handling and support for combination products and medical devices. Oversees regulatory team as they support combination products and medical devices.
- Required Education: Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject
- Preferred Education: Relevant advanced degree preferred
- Required Experience: 12+ years pharmaceutical or industry related experience. 5+ years in quality systems and process improvement or regulatory affairs. Proven 7+ years in a leadership role with strong management skills
- Experience working in a complex and matrix environment. Strong communication skills, both oral and written
- Preferred Experience: 5-7 years in regulatory affairs. 10+ years pharmaceutical experience (medical device/combination product)
- Experience developing and implementing successful global regulatory strategies. Interfacing ability with government regulatory agencies
- Experience working with Health Authority
- Note: Higher education may compensate for years of experience
*Position flexible based on experience
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)
Travel: Yes, 25 % of the Time
Job Type: Experienced