- Provides regulatory directions into local business objectives by managing regulatory projects to obtain the most rapid and optimal registration of new products and indications.
- Participates in and support the development and implementation of regulatory strategies to facilitate the development and approval of Products in Korea
- Ensures all regulatory applications and activities occur within defined timeframes according to Regulatory Stragtegy & Standards, including achieving the best indications possible.
- As assigned, participate in industry associations on regulatory policy and regulations; taking regulatory convergence into consideration
- With guidance, contribute to global regulatory strategies, considering local regulation and business needs
- As assigned, gather and disseminate regulatory intelligence within the Affiliate; involving regional and global organisations, when appropriate
- Provide Regulatory Affairs input into relevant cross-functional Affiliate business strategies (e.g. market access, medical affairs, promotional activities, public policy, technical assessments, technical agreements, local manufacturing/packaging activities, legal issues, etc.)
- Develop innovative, risk-based regulatory strategies and workplans for assigned products or business areas within the Affiliate to accelerate access in alignment with global
- Participates as a standing member or ad-hoc member in the cross-functional product development meeting or business meeting and advise others on applicability of new or existing regulations and guidelines including providing internal teams with direction on regulatory authority interactions
- Develop local regulatory strategic management plan and pipeline datatbase. Periodically update and maintain uptodated.
- Maintain Country Specific Requirements up to date and communicate it with Global PDR & PTR. Also,keep the regulatory team informed and updated
- Proactively Manage Patent Status & Trademarks for the pipeline under development and properly communicate with Global Patent/Trademarks team and Local Legal Agency to protect Intellectual Properties
Ensure all regulatory applications and activities occur within defined timeframes according to Regulatory Strategies, including achieving the best indications possible and effectively managing all regulatory aspects of a product through the entire lifecycle
- Where assigned, supervise and manage execution of regulatory filing activities across your staff, which may involve performing some of the work of DRA staff
- Interact and negotiate with local HAs and internal stakeholders to build and cultivate trusted partnerships
- Ensure regulatory filings are aligned with commercial and supply needs to assure business continuity
Influence internal and external stakeholders for successful regulatory outcomes
- Ensure and maintain the registration of currently marketed products through entire lifecycle, complying to global Regulatory standards and QMS
- Ensure Regulatory implementation of the variations to the existing products and support its’ implementation in a timely manner
- With your team, develop and maintain current knowledge of international and local regulations and other governing regulatory practices, policies, procedures, processes, systems and standards
- Support regulatory inspection-readiness for the Affiliate, including leading or participating in internal/external regulatory audits
- Ensure assigned Affiliate regulatory activities comply with global standards and local regulations
- Ensure all the PV activities should be completed as defined in global SOPs & QMS
- Ensure that all the changes (CDS, TRIC) for responsible products are proceeded according to local SOPs and avoid the non-compliance
- Timely manage HA request within defined timeframe by HA:(Re-evaluation, Safety instruction, Patent, Orphan Renewal, Barcode registration)
- Timely inform the relevant stakeholders of the approval
- Ensure the Regulatory Affairs database is updated with regulatory activities, timelines and priorities as per the Regulatory Standards and ensure accuracy of the data(GPRS, Local Tracking logs)
Ensure that teams are adequately resourced, motivated and skilled to support the Regulatory function
- Recruit, onboard, train, develop and retain talent on the assigned Affiliate Regulatory Affairs team (a sub-set or sub-sets of the overall Affiliate DRA staff)
- Oversee and manage Regulatory Affairs work of the assigned Affiliate DRA staff
- Work with Affiliate DRA Head to identify and recommend appropriate Regulatory Affairs resources and budget
- Provide clear standard/expectations for performances and offers support through knowledge sharing and cooperation.
- Overall 9 years work experience in Pharmaceutical Industry but at least 6-7 years of experience in Regulatory Affairs/2~3 years RA managing experience Preferred
- B.A. and/or above majored in Pharmacy and Pharmacist licensed preferred.