Regulatory Affairs Manager(1 year contract)

    • Taipei, Taiwan

Site Name: Taiwan - Taipei
Posted Date: Mar 12 2020
JOB PURPOSE :
Manage regulatory activities in facilitating GSK Taiwan business goal achievement and ensure commercial activities to comply with government regulations and corporate regulatory policies, including:

  • Ensure products within scope (incl. medicines, devices, cosmetics and foods) can be placed on the market with optimal yet compliant claims, advertising and promotion in line with commercial plans.
  • Ensure products are maintained and meet internal and external compliance requirements.
  • Be a productive part of defined local regulatory team, including being a proactive partner to other stakeholders, e.g., marketing/sales within local commercial business, supply chain and quality etc.
  • Support Regulatory Director to engage with the external regulatory environment within defined area of responsibility and act as a responsible voice of GSK CH with local regulators, trade associations and other key external regulatory bodies.
  • Work together with regulatory colleagues and other stakeholders to proactively look for opportunities and solutions to challenges, including leading implementation of improvement initiatives.
  • Provide input into regulatory strategies and process improvement/compliance activities within defined areas of scope.

KEY ACCOUNTABILITIES / RESPONSIBILITIES:
Product license Registration/Notification , including:
  • Develop regulatory strategy/product registration plan
  • Prioritize regulatory projects and site registration timeline
  • Obtain approval / complete notification to meet launch timeline
  • Monitor, consult and advise regulatory processes to LOC and above country stakeholders
  • Address trouble shooting for regulatory events
  • Deal with Category team for ongoing and forthcoming product registrations/switch projects to ensure get sufficient support for submissions
  • Conduct L1 audit for identified or potential risk area
  • To work with cross-function (commercial, supply chain, medical and quality teams) to ensure proper manage on new product launch and post-approval change control
  • Maintain label information to make sure product usage and safety information updated

Drive Regulatory Change and Process
  • Gain regulatory intelligence to cope with regulatory environment change and seek for business opportunities and report new regulations on Cx products to GRA
  • Analyse regulatory issues and communicate with key stakeholders. Work together to help develop plans to mitigate, so that we can deliver science that is robust and aligned with business needs in a timely manner.
  • Contact window for regional/headquarters/sites/regional demand hub
  • Build up communication channel for any regulatory events or issues among departments internally or between the company and the authority externally
  • Compliance of Artwork registration, Artwork creation / revision initiation and final approval, and Approve the first sample of new / revised printed component
  • Drive Regulation change through participation of Industry Association Taskforce
  • Complete e-learning/training on RA global and local SOPs
  • Manage compliance within defined portfolio/activity streams in line with GSK CH expectations - support key processes and ways of working (eg. In relation to GSK CMC, quality, product labelling requirements as well as local MoH regulations)

Ensure regulatory compliance in commercial activities
  • Participate the marketing activities design and provide advice in order to allow well design in activities
  • Ensure products within scope (including medicines, medical device, cosmetics and foods) can be placed on the market with optimal yet compliant claims, advertising and promotion in line with commercial plans

KNOWLEDGE / EXPERIENCE / SKILLS / COMPETENCIES REQUIRED :
Education and Experience:
  • Bachelor degree or above in Life-science, pharmacy background and professional knowledge of regulatory affairs or legal basis
  • Minimum of 3 years' experience in Regulatory Affairs

Essential Skills and Abilities:
  • Business acumen
  • Good communication / interpersonal skills
  • Excellent English written and verbal abilities
  • Familiar with regulatory environment and the communication with regulatory authority
  • Strategic thinking in driving direction among stakeholders

List of additional Role and Responsibilities
  • Support Regulatory and Product Development Director (Regulatory & PD Director) for external engagement in regulatory issues
  • Deputy for Regulatory and PD Director


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