PHARMAFull time
Regulatory Affairs Manager I
By Admin · Regulatory Affairs
BANGALORE (IN)HYBRIDPOSTED: 10/11/2026
PHARMAFull time
HIRING ORGANIZATIONASTRAZENECAPharmaceuticals / Biopharmaceuticals / Healthcare
ROLE OVERVIEW
AstraZeneca is hiring a Regulatory Affairs Manager I in Bangalore. This full-time, hybrid individual contributor role leads planning and execution of global regulatory maintenance deliverables within the maintenance Center of Excellence.
ROLE DEFINITION & RESPONSIBILITIES
- •Plan, coordinate and execute assigned global regulatory maintenance deliverables end-to-end as an individual contributor within a Global Regulatory Execution Team.
- •Contribute to regulatory submission strategy for simple to moderately complex products or regions, identifying risks and opportunities and managing procedures through approval.
- •Provide regulatory guidance on procedural and documentation requirements to cross-functional teams and the GRET across regions.
- •Lead maintenance of global labelling documents for established brands, including revised printed labelling such as USPIs and regional labelling.
- •Prepare, author and deliver regulatory maintenance submissions, including divestments, marketing authorisation transfers, withdrawals, response documents, risk management plans and core labelling documentation.
- •Develop and maintain submission delivery and content plans using digital tools such as Veeva Vault (ERV), and update stakeholders on status.
- •Identify regulatory risks and propose mitigations to the Lead RPM and cross-functional teams; support compliance activities including work requests, submission tracking, TMF and document management.
- •Coach and mentor colleagues, share knowledge, contribute to process improvement, and use AI tools responsibly to improve efficiency.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Relevant university degree in science or a related discipline.
- Minimum 6+ years of relevant regulatory experience in the biopharmaceutical industry, including license maintenance, labelling and publishing, and working in regulated markets.
- General knowledge of drug development.
- Thorough knowledge of the regulatory product maintenance process.
- Strong project management skills.
- Leadership skills, including experience leading multi-disciplinary project teams.
PREFERRED QUALIFICATIONS
- •US regulatory affairs experience.
- •Experience managing regulatory deliverables at the project level.
- •Experience working with people from locations outside India, especially Europe and/or USA.
REQUIRED VERIFIED SKILLS
Excellent English written and verbal communication.
Cultural awareness.
Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions.
Proficiency with project management tools (e.g., MS Project) and document management tools.
Basic understanding of emerging technologies such as AI and ML.
Ability to use digital tools and solutions relevant to the role.
Influencing and stakeholder management skills.
Ability to analyse problems and recommend actions.
Continuous improvement and knowledge-sharing focus.
Ability to work independently and as part of a team.
Digital tools such as Veeva Vault (ERV).
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
ORGANIZATION CONTEXT & CULTURE
AstraZeneca is a biopharmaceutical company that discovers, develops and commercialises prescription medicines for serious diseases.
TEAM SIZE: 89,000+ employees
INDUSTRY: Pharmaceuticals / Biopharmaceuticals / Healthcare
APPLICATION ADVISORY
Highlight your 6+ years of regulatory experience, especially in license maintenance, labelling and publishing for regulated markets. Mention project management and leadership of multi-disciplinary teams, and name digital tools you have used such as Veeva Vault (ERV) or MS Project. If you have US, European or other non-India regulatory exposure, bring that forward.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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