Head of RA

A globally renowned pharmaceutical company is looking for their next Head of RA
Your new company
They are a leader in pharmaceuticals and are one of the world's largest biotech companies.

Your new role
They are seeking a dynamic and experienced Head of RA to lead the company's RA division.

Key Responsibilities
  • Develop and execute global and regional regulatory strategies aligned with the company’s product pipeline, lifecycle plans, and commercial goals.
  • Provide regulatory guidance to senior leadership on risks, opportunities, and regulatory pathways.
  • Serve as the regulatory subject-matter expert for new product development, line extensions, and post‑approval changes.
  • Lead and oversee the preparation, review, and submission of regulatory dossiers to global and local health authorities.
  • Ensure timely approvals for product registration, renewals, variations, and amendments.
  • Manage interactions, meetings, and correspondence with regulatory agencies.
  • Ensure ongoing compliance with applicable regulations, guidelines, and standards (e.g. ISO, local regulatory laws).
  • Establish and maintain internal regulatory policies, procedures, and SOPs.
  • Monitor regulatory intelligence and assess the impact of regulatory changes on the business.
  • Partner closely with R&D, Quality, Clinical, Manufacturing, Supply Chain, Marketing, and Commercial teams to embed regulatory requirements into business processes.
  • Provide regulatory input for labelling, promotional materials, claims, and advertising reviews.
  • Manage external consultants, agents, and local regulatory representatives as required.
  • Drive capability development and succession planning within the RA function.
  • Identify and proactively manage regulatory risks, including compliance gaps and approval delays.
  • Drive continuous improvement initiatives to enhance regulatory efficiency, quality, and timelines.


What you'll need to succeed
  • Bachelor’s degree in Pharmacy, Life Sciences, Biotechnology, Chemistry, Engineering, or a related discipline.
  • Minimum of 10 to 15+ years of progressive experience in Regulatory Affairs, with 5+ years in a leadership or regional/global role.
  • Proven track record of successful product registrations and regulatory approvals across Malaysia.
  • Strong experience working directly with global and/or local health authorities (NPRA).

What you'll get in return
  • Competitive salary
  • Career advancement opportunities

What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV to ChunKeat.Wong@Hays.com.my, or call me at +60 3-5870 5024 now.
If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.

Summary

Job Type
Permanent
Industry
Pharmaceuticals
Location
Malaysia
Specialism
Life Sciences
Ref:
1286811

Talk to a consultant

Talk to Chun Keat Wong, the specialist consultant managing this position, located in Sunway
Corporate Suite 19-01 at Sunway Resort Hotel,, Persiaran Lagoon,

Telephone: +60 3-5870 5024