EXT - Regulatory Affairs Executive (Kuala Lumpur, Malaysia, Federal Territory of Kuala Lumpur)
Notify me about similar jobsAbout this opportunity
This is an agency‑hired role supporting the Regulatory MSI Department for Boehringer Ingelheim Malaysia. The successful candidate will be employed by the agency and assigned to Boehringer Ingelheim Malaysia. This role is not a direct employment with Boehringer Ingelheim.
The Position
Are you ready to take on a role where your regulatory expertise drives healthcare innovation forward?
This role is responsible for achieving timely and successful product registrations in accordance with corporate and local strategies, collecting and sharing updates on new regulations and guidelines with the local RA team, and ensuring compliance with company regulatory policies, regulations, and procedures.
Task & Responsibilities
Regulatory Planning and Submission
Support the regulatory tasks & projects, including attaining, maintaining product and operation licenses for assigned portfolio.
Support the compilation of registration applications for assigned portfolio and ensure timely approval.
Monitor submission progress of submissions and coordinate timely responses to health authority queries.
Comply with corporate policies, regulations & procedures, timely implementation of Company Core Data Sheet (CCDS), Change Review Committee (CRC) and local change control procedures.
Regulatory Intelligence and Interaction
Collect and share new or updated local regulations from various sources with the local RA team.
Communicate with Regulatory Authorities and local industry groups on regulatory issues.
Cross-functional collaboration and Support
Provide administrative support to local RA team for regulatory consultation and collaboration with local business stakeholders.
Support and contribute to local or global initiative and project implementation.
Quality and Compliance
Perform timely administrative entries in regulatory databases across all products in the assigned territories to reflect current registration status and requirements.
Support the local RA team for audits and inspection readiness.
Archive local regulatory submission documents.
Requirements
Degree in Pharmacy or Life Sciences or equivalent professional qualifications.
1 to 3 years of experience working in the pharmaceutical, generic, medical device or healthcare industry.
Good knowledge of national drug regulations and procedures.
Good communication skills for internal & external interactions.
Good computer literacy skills, Microsoft Office proficiency, comfortable working with databases.
Analytical mindset and meticulous attention to detail.
About the Assignment Company
Boehringer Ingelheim Malaysia is the host company for this assignment. In this role, you will support Boehringer Ingelheim’s Regulatory MSI Department activities while being employed by the agency .
Why this assignment?
This role offers the opportunity to work closely with Boehringer Ingelheim teams on meaningful operational initiatives in a fast-paced environment. Please note that this is an agency-hired assignment, and all employment terms and conditions will be managed the agency .
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Job details
How this role compares
Computed from every other active Regulatory Affairs role in our database, not just this employer's listings.
We currently track 438 comparable Regulatory Affairs roles across 98 biopharma companies.
Salary context
119 of 438 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 438 comparable roles
+ 45 more countries
Seniority mix
348 of 438 peers have a known seniority level
Therapeutic area mix
36 of 438 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
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Get an email when we spot other openings like this one – same job function, comparable seniority, roles you'd actually want to see.
How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.