職位描述
Primary Responsibilities
The Regulatory Manager will have the following responsibilities:
· Deliver innovative and beneficial consumer health products regulatory strategy in a timely manner.
· Strategic leadership of consumer health product development and NPD/MPR registration projects to meet the business objectives for the business.
· Straight to point communication with stakeholders, such as: Plant, Regional, HQ, MKT, R&D, Med, Toxicity, Clinical Operation, GCMC etc.
· 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.
· Direct the growth and professional development of the RA team members.
· Manage the regulatory professionals ensuring high quality deliverables against their objectives
· Accountability for capacity and capability management.
· Development of working/partnering relationships with key agencies in the business.
· Timely submission of regulatory applications for new product registrations.
Be a recognized as a key partner for local business activities and initiatives, including licensing opportunity considerations, innovative regulatory strategies, and talent management.
Technical Skill Requirements· Good technology of CMC, preclinical, clinical.
· Understanding of regulatory agency philosophies and guidelines. Capture regulatory trend to reflect into regulatory strategy change. Experience preparing and submitting health product registration applications, variations and renewals. Working with and influencing, opinion leaders, external organizations and facilitating approval of innovational projects.
· Communicates effectively using a variety of mediums appropriate to the setting
· Can negotiate skillfully in tough situations with both internal and external groups. Can be direct and forceful as well as diplomatic. Gains trust quickly of other parties to the negotiations
· Effectively identifies issues and challenges and works with partner groups to identify options and implement agreed solutions
· Understands how role is impacted by and contributes to external business environment and financial drivers
· Makes decisions in a timely manner, sometimes with incomplete information and under tight deadlines and pressure; able to make a quick decision. (16- Timely Decision Making)
· Makes good decisions based upon a mixture of analysis, wisdom, experience, and judgment; most of his/her solutions and suggestions turn out to be correct and accurate when judged over time; sought out by others for advice and solutions. (17 – Decision Quality)
· Will stand up and be counted; doesn't shirk personal responsibility; can be counted on when times are tough; willing to be the only champion for an idea or position; is comfortable working alone on a tough assignment. (57- Standing Alone).
Qualifications (i.e., preferred education, experience, attributes)· Tertiary qualifications in nutrition, food, pharmacy or a science degree
· 6+ years Regulatory Affairs experience gained with multinational pharmaceutical or food companies working with consumer health products.
· Regulatory Experience with either as healthcare industry is required.
· Excellent English skills for accurate and effective communication.
· Proven ability to manage 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.
