Job Title:
Specialist - Regulatory Affairs Manager
📍 Bangalore, Karnataka, India
🕒 Full-time
🔢 Job ID: 291311
Company Overview
Join us in innovating with science and technology to enrich lives across Healthcare, Life Science, and Electronics. We are passionate about caring for a diverse mix of people, customers, patients, and the planet. If you see yourself imagining the unimaginable, this is the place for you.
Role Overview
As a Specialist Licence Management professional, you will prepare dossiers and execute actions to support license security and product compliance across markets, ensuring alignment with company policies and health authorities’ requirements.
You will:
Navigate complex challenges to align all involved disciplines on licensing strategy and approach.
Work in a matrix organization collaborating extensively with stakeholders from Global Regulatory Affairs and other functions.
Support the resolution of complex regulatory tasks under supervision and guidance from experienced personnel.
Who You Are
Minimum Qualifications
5+ years of overall experience in the Pharma environment, competent authority, or academia/R&D relevant to the role.
At least 1 year of experience in Regulatory Affairs.
Degree in Life Science or related discipline, preferably MSc.
Experience & Skills
Experience preparing and managing regulatory documentation, including full international submissions (e.g., new product applications) or major variations.
Knowledge of life-cycle management activities in at least two regions (Europe, USA, International preferred).
Strong understanding of Regulatory Affairs, especially post-approval changes, dossier types, and global regulatory procedures.
Familiarity with supportive registration and life-cycle management documents (CPPs, GMP certificates, Marketing Licenses, Authorizations to Operate, etc.) and legalization frameworks.
Ability to review and interpret country-specific and international regulatory guidelines, policies, and regulations to create submission-ready deliverables.
Adherence to timelines with proactive risk communication.
Project management and documentation skills with proactive communication.
Experience with Regulatory Information Management (RIM) and Electronic Document Management Systems (EDMS).
What We Offer
A diverse, inclusive environment that fosters innovation and excellence.
Opportunities to develop and grow at your own pace.
Comprehensive benefits including:
Financial & Protection: Long-term financial stability for you and your family.
Health & Wellbeing: Support for physical and mental health (health checkups, medical insurance).
Family: Benefits supporting fertility and family life stages.
Time Away: Paid leaves and support for important life events.
Lifestyle: Flexible work, gyms, car benefits, and shopping discounts.
Recruitment Process
|
Step |
Description |
|---|---|
|
You apply |
Submit your application online or join our Talent Zone. |
|
We screen |
Application review to identify good fits. |
|
We assess |
Interviews conducted via phone, video, or in-person. |
|
Mutual agreement |
Finalize the offer if both parties agree. |
|
Work your magic! |
Onboarding and preparation for your new role. |
Important Notice
Beware of fraudulent job offers. Verify all employment opportunities through official company channels.
Apply Now
Join a passionate team dedicated to sparking discovery and elevating humanity. Work your magic with us!
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