Senior Regulatory Affairs Specialist
About this opportunity
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com .
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Regulatory Affairs Group
Job Sub Function:
Regulatory Affairs
Job Category:
People Leader
All Job Posting Locations:
Bangkok, Bangkok, Thailand
Job Description:
Essential Job Duties and Responsibilities
The Senior Regulatory Affairs Specialist is responsible for maintaining all pharmaceutical product licenses in Thailand, Cambodia and Myanmar market. Ensure business continuity through the product registration, lifecycle management, regulatory compliance and vital documents management.
Prepare, coordinate and submit regulatory applications, including registrations, variations, renewals and lifecycle maintenance activities.
Ensuring that life-cycle management activities of pharmaceutical products are carried out in compliance with Johnson & Johnson standards.
Monitor regulatory changes and assess potential business impact to ensure compliance as per local market regulations or requirements, as well as internal standard procedures.
Managing all changes and quality issues related to regulatory activities according to internal procedures.
Coordinate communications with the Thai FDA and relevant stakeholders.
Coordinating with cross functional team to ensure that new products and/or approved variations are implemented on time for uninterrupted supply chain including launch readiness.
Ensuring timely implementation of package inserts and packaging components.
Ensuring that product package inserts are not deviated from the international package inserts or otherwise follow management of local labeling deviation.
Assessing and communicating any new local regulations that impact the business to all relevant stakeholders.
Establishing and maintaining strong relationships with internal stakeholders across local, regional, and global levels, as well as external stakeholders such as health authorities and third-party suppliers.
Manage vital documents retention in RA storage room and keep the vital document list storage at outsource vendor e.g. Iron Mountain company up to date.
Keep the registration licenses up to date throughout the lifecycle of products as required by local regulations and as data emerges, where applicable.
Performing any additional duties assigned by your supervisor.
Minimum Qualification
University degree in pharmacy, Pharmaceutical Sciences.
Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers - proficiency in written and oral English is required.
Excellent computer proficiency e.g. MS Office.
Must be able to work independently with minimum supervision to meet tight deadlines and maintain a positive attitude.
Previous experience in preparing documents for health authority submissions is desirable.
Ability to interpret complex issues and technologies and present them in simple terms.
Demonstrated ability to handle multiple projects.
Must be able to develop and maintain excellent working relationships.
Good collaboration with and communication to all relevant stakeholders
Other requirements
Pharmacist license
Required Skills:
Preferred Skills:
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 83 comparable Senior Regulatory Affairs roles across 39 biopharma companies.
Salary context
32 of 83 peers report a salary range (USD, annualized)
Peers share this role's job function and a matching or adjacent seniority level -- not necessarily the same therapeutic area or country.
Where these roles are based
Top locations among the 83 comparable roles
+ 11 more countries
Seniority mix
83 of 83 peers have a known seniority level
Therapeutic area mix
6 of 83 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.
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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.