Pfizer Regulatory Affairs Manager in Tamsui, Taiwan
- The Pfizer Consumer Healthcare (PCH) Regulatory Affairs Manager will lead the regulatory team providing leadership, strategic regulatory direction and managerial oversight for PCH category products. The Regulatory Affairs Manager will ensure regulatory strategies and plans are developed and executed in a timely manner and work closely with marketing and business development to create innovative regulatory strategies. The Regulatory Category Manager will interface with other function leads (e.g. R&D leaders, Commercial, Clinical/Medical Affairs/Safety) to ensure collaborative connectivity with these key stakeholders, business strategies and objectives.
Responsibilities: The Regulatory Manager will have the following responsibilities:
Deliver innovative and beneficial consumer healthcare supplement products with competitive claims in a timely manner.
Strategic leadership of consumer health supplement product development and registration projects to meet the business objectives for the business.
Full compliance with all government regulations and corporate policies including oversight of corrective actions.
Coordination and implementation of consistent standards and processes, as well as sharing of best practices across the PCH regulatory organization.
Accountability for capacity and capability management.
Oversee the development of strong working/partnering relationships with key agencies in the business.
Timely submission of regulatory applications for PCH category products and life cycle management adopting strategies for minimising the registration approval time frame
Be a recognised as a key partner for local business activities and initiatives, including licensing opportunity considerations, innovative regulatory strategies, and talent management.
Qualifications (Training, Education & Prior Experience):
Tertiary qualifications in nutrition, pharmacy or a science degree
You will have 5 years + Regulatory Affairs experience gained with multinational pharmaceutical or food companies working with health supplements such as vitamin and mineral supplements
Regulatory Experience with Consumer products required.
Proven ability to manage complex regulatory issues and is solutions orientated.
Proven ability to consistently deliver to time, cost and quality standards.
General management experience with line management and demonstrates leadership in driving for success is desirable
Demonstrable experience of effective delivery of objectives in a complex matrix environment.
Proven track record in working with government officials.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.