RA (Senior) Specialist/Associate Manager
About this opportunity
Job Description
Role descriptionProduct registration & maintenance
Develop the regulatory strategy/plan for the earliest launch of new products on best conditions (indication, forms, minimum documents requirements etc) in Korea by sourcing necessary documents from HQ’s worldwide regulatory function.
Implement/manage products registration procedures required by Korean pharmaceutical regulation to achieve the earliest market entry.
Harmonize Korean products labels and promptly notice to GRA about local impositions for the labelling from the MFDS to avoid any local issue.
Update the safety information in line with the CDS and other reference countries.
Product lifecycle maintenance: Keep product license to be compliant with regulations.
Product QA
Package compliance: Secure the package compliance in line with the local regulation and AZ compliance.
Responsible for company’s compliance into all relevant Korean and AZ’s procedure including Good Regulatory Practice (GRP).
Review the compliance of promotional literatures from regulatory perspective
Relationship with customers (internal & external)
Maintain high level of authorities’ satisfaction through application of high
professional standard in all contacts, quick resolution of authorities’ enquiries and provision of support.
Maintain positive relationship with local contractors, customers and internal staff.
Comply with the relevant regulations and AZK’s ethical business practice with full understanding of the code of conducts.
Intelligence Gathering
Get any information relating to changes in the relevant regulatory regulations and health authorities and report to RA manager on any expected impact on our business.
Develop/maintain good relationship with government agencies and regulatory bodies to achieve above.
Skills
Sufficient regulatory knowledge and experience
Good command of spoken and written English
Qualifications
Education: BA or MA biology-related science (pharmacy preferred)
Language: Korean and English
Work Experience: Regulatory experience for 5 year minimum, Pharma industry experience 5-10 years
Competencies:
Experience of working on cross-functional teams
Knowledge of the drug development process
※ 채용 절차법에 따른 고지 사항
1. 제출한 서류는 채용 절차법에 따라, 일체 반환 의무가 없습니다.
2. 보훈대상자 및 취업보호대상자는 관련법에 의거하여 우대합니다.
3. 해외 여행 결격사유가 없어야 합니다.
4. 본 채용은 수시진행으로, 우수인력 채용 시 마감될 수 있습니다.
Date Posted
11-5월-2026
Closing Date
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
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 145 comparable Manager Regulatory Affairs roles across 42 biopharma companies.
Salary context
37 of 145 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 145 comparable roles
+ 16 more countries
Seniority mix
145 of 145 peers have a known seniority level
Therapeutic area mix
22 of 145 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.
Open in 2 locations
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.