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Regulatory Affairs Manager II

By Admin · Regulatory Affairs

BENGALURU (IN)HYBRIDPOSTED: 10/11/2026
PHARMAFull time
HIRING ORGANIZATIONASTRAZENECAPharmaceuticals / Biopharmaceuticals / Healthcare
AstraZeneca

ROLE OVERVIEW

AstraZeneca is hiring a Regulatory Affairs Manager II in Bangalore to work as an individual contributor for global markets within its maintenance Center of Excellence. The role combines hands-on regulatory affairs management with project management for moderately complex products and regions.

ROLE DEFINITION & RESPONSIBILITIES

  • •Contribute to regulatory submission strategy, flag submission risks and opportunities, and drive applications through approval
  • •Provide regulatory guidance on procedural and documentation requirements to the Global Regulatory Execution Team and cross-functional teams across regions
  • •Maintain global labelling documents for established brands and coordinate revised printed labelling, including USPIs and other regional labelling
  • •Analyse regulatory procedures and special designations used during development, authorisation and product extension
  • •Plan, prepare (authoring where relevant) and deliver regulatory maintenance submissions of simple to increasingly complex scope
  • •Develop and maintain submission delivery and content plans using digital tools such as Veeva Vault (ERV), with proactive status updates to stakeholders
  • •Coordinate project planning tool inputs and revisions and promptly flag unforeseen resource demand changes to the Lead RPM and line manager
  • •Identify regulatory risks and propose mitigations, support compliance activities including work requests, submission tracking, TMF and document management, and provide coaching, mentoring and knowledge sharing

QUALIFICATIONS & REQUIREMENTS

REQUIRED QUALIFICATIONS

  • Relevant university degree in Science or a related discipline
  • Minimum 8+ years of relevant regulatory experience in the biopharmaceutical industry, including licence maintenance, labelling and publishing, and work 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
  • Ability to perform regulatory affairs management for moderately complex products and regions under minimal supervision and to lead cross-functional activities

PREFERRED QUALIFICATIONS

  • •US regulatory affairs experience
  • •Experience managing regulatory deliverables at the project level
  • •Experience working with people based outside India, especially Europe and/or the 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 such as MS Project and document management tools
Basic understanding of emerging technologies such as AI and ML
Use of digital tools and solutions relevant to own work tasks
Ability to work independently and as part of a team
Influencing and stakeholder management skills
Ability to analyse problems and recommend actions
Continuous improvement and knowledge sharing focus

COMPENSATION & REWARDS

Salary: Competitive / Disclosed upon candidate shortlisting

ORGANIZATION CONTEXT & CULTURE

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that discovers, develops and commercialises prescription medicines for some of the world's most serious diseases.

TEAM SIZE: 89,000+ employees
INDUSTRY: Pharmaceuticals / Biopharmaceuticals / Healthcare

APPLICATION ADVISORY

Highlight your 8+ years of biopharmaceutical regulatory experience and make the posting's specifics visible: licence maintenance, labelling and publishing, and regulated-market exposure. Emphasise work with submission delivery and content plans in Veeva Vault (ERV) and project management tooling such as MS Project, plus any leadership of multi-disciplinary teams. If you have US regulatory affairs experience, project-level regulatory deliverables, or collaboration with Europe/USA-based colleagues, call that out as it matches the preferred list.
RECOMMENDED TRAINING
1/5
Biologics Regulatory Affairs Certification

Biologics Regulatory Affairs Certification

READY TO SUBMIT?

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