Associate Director, Regulatory Liaison Asia Pacific

1 week ago

Macquarie Park, Australia MSD Full time

Associate Director, Regulatory Liaison Asia Pacific Regulatory Affairs

  • Permanent fulltime position with competitive renumeration and benefits
  • Unique opportunity to work above market with direct collaboration with local country and headquarters
  • Upskill and grow in an area you're passionate about, whilst being fully supported and encouraged.
  • Join a trusted global leading pharmaceutical organisation
  • Requires flexibility to liaise with global timezones
  • Potential for up to 20% international travel


The Regulatory Liaison role is a broad role encompassing all aspects of regulatory strategy to support countries in region, including clinical, CMC and risk management requirements, and oversight of strategic regional labelling issues.


What You Will Do

Responsibilities include, however not limited to:

  • Serves as "single point of contact" for specific products for country and headquarters (HQ)
  • Provides regionally focused strategic input to product development across region and across portfolio
  • Contributes to region specific aspects of a development strategy
  • Leads identification of regional specific elements of submissions
  • Owns and leads the overall regional product regulatory strategy, including the corporation and maintenance of regulatory requirements for health authority registration approval
  • Monitors and communicates key strategic issues related to program progress and issues to/from countries and HQ
  • Helps ensure Health Agency deficiency letters are appropriately addressed in a timely manner, by providing specific input from the regional perspective
  • Ensures alignment of strategy and priorities for portfolio of products with stakeholders
  • Contributes to development and execution of regional regulatory policy issues.

What You Must have

  • Bachelor graduate degree in pharmacy, biological science, chemistry or related discipline required, coupled with extensive experience in regulatory affairs.
  • Individuals with other credentials and who possess an excellent working knowledge of Regulatory Affairs or Clinical Research gained within industry would be considered
  • Outstanding, interpersonal, written and oral communication skills; outstanding collaborative skills with an ability to work both proactively and reactively in a timely manner in a dynamic fastpaced environment
  • Ability to assess, prioritize, and complete multiple projects, tasks, and/or responsibilities
  • Able to manage complex problems/projects by exercising independent decision making and analytical thinking skills
  • Knowledge/experience of regulations, registration guidelines and regulatory processes for NCEs biologics and product life cycle maintenance in general and preferably in the intended region
  • Ability to work independently to achieve results
  • Ability to work in crossfunctional and international environment; detail
- and goal-oriented, quality conscientious, and customer-focused

  • Ability to adhere to strict project timelines
  • Strong team player, good judgment and problemsolving skills, with ability to identify, analyse, and resolve problems in a timely manner
  • Fluent written and spoken English is required, with a high attention to detail

What You Can Expect
-
Work autonomously whilst being supported and encouraged

  • Exposure to
    upskill and develop in your role
  • Flexibility and
    opening doors to other opportunities and skillsets
  • Joining a
    collaborative team of
    likeminded individuals
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Search Firm Representatives Please Read Carefully

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:
R250702

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