Regulatory Affairs Manager
On-siteBengaluru, Karnataka, India
Job Summary
Execute regulatory strategies for APAC markets aligned with global standards, defining pathways and documentation for ophthalmic devices, lenses, eye drops, cosmetics, and dietary supplements. Lead end-to-end submission ownership by guiding SSC RA teams through authority interactions, deficiency responses, and electronic submissions via country-specific portals like NMPA and PMDA. Manage lifecycle and change control across product categories while maintaining RIMS data integrity and audit readiness. Act as the central APAC RA hub, coordinating submissions with dealers, local agents, and external consultants to ensure regional compliance with EU MDR, US FDA, and MDSAP frameworks.
Required Qualifications
- Bachelor's degree in Life Sciences, Biomedical Engineering, Pharmacy, or related discipline
- 7+ years in regulatory affairs within the healthcare / medical device industry
- significant experience coordinating regulatory activities across multiple APAC countries (hub role)
- working with dealers, in‐country RA agents, or external consultants
- Exposure to global regulatory frameworks (EU MDR, US FDA, MDSAP) is mandatory
- Proven experience with country‐specific requirements in major APAC markets (e.g. China, Japan, South Korea, Australia, India, ASEAN)
- Managing regulatory submissions for ophthalmic devices and/or eye care products
- familiarity with requirements for cosmetics and dietary/health supplements in at least one APAC jurisdiction
- Ability to independently manage multiple regulatory projects
- Mandatory experience with RIMS (Veeva RIM, Ennov, TrackWise, MasterControl, etc.)
- Strong regulatory data management and reporting skills
- Working knowledge of AI applications in regulatory affairs
- Experience with AI-enabled tools for documentation, analytics, or automation
- Ability to integrate digital technologies into regulatory workflows
- Highly autonomous with strong ownership mindset
- Excellent planning, prioritization, and execution capability
- Strong stakeholder engagement skills across global teams
- Ability to translate complex regulatory requirements into clear business actions
- Proven ability to coordinate country‐level RA activities in a regional hub model
- Strong skills in building standard processes, templates, and KPIs for multi‐country regulatory execution
- Experience managing virtual teams or influencing without direct line authority across cultures and time zones
Desired Qualifications
- Prior regulatory experience covering at least two of the following categories in APAC is strongly preferred: ophthalmic medical devices (including lenses), drug‐device combination products (e.g. medicated eye drops), cosmetics, and dietary supplements/health supplements
- Strong experience with APAC regulatory submissions and lifecycle management
- Experience with EU MDR technical documentation and PMS requirements
- US FDA submission types and regulatory pathways
- MDSAP audit principles and compliance expectations
- Ability to design and continuously improve end‐to‐end (digital) submission workflows
- Ability to leverage AI tools to improve efficiency in dossier compilation, gap assessment, and regulatory intelligence analysis
- Ability to pre‐validate electronic submission packages using AI or rules‐based tools
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