[Strategy/Planning]
- 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
[Filings]
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
[Regulatory Compliance]
- 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)
[People Management/Leadership]
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.
Requirements
- Overall 10 years work experience in Pharmaceutical Industry but at least 8years of experience in Regulatory Affairs/2~3 years RA managing experience Preferred
- B.A. and/or above majored in Pharmacy and Pharmacist licensed preferred.
담당자: 김대식
연락처: 02-6925-5391
이메일: ds@hrfind.co.kr