
Regulatory Project Manager
2 weeks ago
This position will be responsible for leading and coordinating regional regulatory registrations. Managing all facets of regulatory support for all segments products and assist in administration work pertaining to activities in regulatory affairs to support regional registration priorities.
**Principal Duties and Responsibilities**:
- Oversee the APAC regulatory submission process with 3rd party regulatory service providers and distributors; oversee the authorship and publication of electronic submissions.
- Manage the development of dossiers for registration of products in countries in the APAC region
- Lead in-country project RA teams while providing regulatory direction to development project teams
- Develop and communicate regulatory strategy for new products by working with the regional and global commercial teams.
- Track and monitor regulatory submissions in APAC markets based on commercial prioritization and business plans
- Establish ZimVie RA policy and procedures and ensures compliance with them.
- Keep all areas of ZimVie informed of regulatory requirements and emerging issues which may affect the registration approval of products in the countries of responsibility
- Communicate with Regulatory agencies.
- Responsible for oversight and prioritization of departmental tasks and projects.
**_This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions"._**
**Expected Areas of Competence**:
- Business proficiency in spoken and written English
- Superior interpersonal and communication skills
- Responsible, professional, detail oriented and with patience
- Strong computer skills (MS Excel)
- Ability to work and partner with both internal and external stakeholders.
- Ability to manage multiple projects and registrations.
**Education/Experience Requirements**:
- Bachelor’s Degree in life sciences, technical (engineering) or related field; advanced degree strongly preferred.
- Minimum of 10 years of experience required in a Regulatory Affairs capacity.
- Experience in the areas of medical devices, drugs, biologics, and combination products regulations is strongly preferred.
- Project management experience is preferred.
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