he Opportunity
As a manager, the function of an Associate Director Regulatory Affairs, APAC (Asia Pacific) is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. Additionally, the individual may develop and supervise regulatory professionals. The individual has department level influence and is generally recognized as an expert resource both within Abbott and externally. The individual may comment on changing regulations and guidance, interface with outside regulatory agencies and trade associations and provide executive management with regulatory metrics/information. The individual may ensure that data are identified, obtained and effectively presented for the registration of products in APAC.
What You’ll Work On
- Identify need for new regulatory policies, processes and SOPs in APAC and approve them.
- Develop and advance the organizations policy and procedures for regulatory affairs and compliance to establish a compliant culture.
- Anticipate regulatory and related obstacles and emerging issues throughout the product lifecycle.
- Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions.
- Develop APAC regulatory strategies and update based upon regulatory changes.
- Conduct regulatory due diligence for potential and new acquisitions and advise management.
- Utilize technical regulatory skills to propose strategies on complex issues.
- Integrate regulatory considerations into the APAC product entry and exit strategy.
- Recruit, develop and manage regulatory professionals.
- Provide guidance for resource and development planning
- Approve regulatory filing strategies based upon proposed preclinical, clinical and manufacturing charges.
- Review and approve labeling to ensure compliance.
- Represent regulatory affairs in product recall and recall communication process in APAC.
- Provide strategic input and technical guidance on regulatory authority queries.
- Oversee processes involved with maintaining annual licenses, registrations, listings and patent information.
- Create project plans and timelines.
- Lead cross functional groups in the development of relevant data to complete a regulatory submission.
- Develop and communicate a vision for the organizational unit assigned.
- Administer/meet regulatory requirements to achieve excellent compliance status with no enforcement actions.
- Negotiate with regulatory authorities during the development and review process to ensure submission approval.
- Write and edit technical documents.
- Ensure compliance with product post-marketing approval requirements
- Review and approve advertising and promotional items to ensure regulatory compliance.
Required Qualifications
- Bachelor's Degree, preferably in science, math or medical fields
- Minimum 10 years’ experience in a regulated industry.
Preferred Qualifications
- Masters in technical area or MBA
- Minimum 5+ years’ experience in regulatory affairs.
- Experience working with Medical Devices, software, or combination products.
- Experience working in supporting APAC region.
- Ability to communicate both orally and in writing in Chinese, Japanese and/or other Asian language.
- RAPS Certification.
