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Open Position

Open Position

Regulatory Affairs Manager(차장~부장 약사)님을 채용합니다.

  • 2021-02-23 17:16:00
  • 1.223.120.93

Position Summary

  • 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.

Main Responsibilities

[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 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.

   담당자: 김대식
   연락처: 02-6925-5391
   이메일: ds@hrfind.co.kr

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