Life Sciences Regulatory Affairs Jobs at Johnson & Johnson, Apply Now!
Are you ready to take the next big leap in your pharmaceutical career? Johnson & Johnson Innovative Medicine is looking for a dynamic and experienced Senior Regulatory Affairs Professional to join its APAC team. This role is based in the Mumbai Metropolitan region and plays a pivotal role in shaping regulatory strategies and driving global health outcomes. Discover how you can be part of one of the world’s most respected healthcare innovators.
About the Company
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Job Posting: Senior Regulatory Affairs Professional APAC
Job Function: Regulatory Affairs Group
Job Sub Function: Regulatory Affairs
Job Category: Professional
Locations: India (Mumbai)
Position Summary
The Senior RA Professional is a member of the Global Regulatory Affairs organization at Johnson & Johnson Innovative Medicine. The position resides in the AP Region and is responsible for working with local regulatory affairs departments, AP regional cross-functional teams, Global Regulatory Teams, and other global functions to define and implement the regional strategy for assigned products.
Responsibilities for Life Sciences Regulatory Affairs:
Regulatory Strategy and Expertise
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Provide strategic input into global regulatory planning based on APAC region requirements.
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Guide local affiliates on submission and approval strategies.
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Maintain up-to-date knowledge of APAC regulatory frameworks.
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Evaluate and support licensing activities within APAC for Life Sciences.
Health Authority & Business Partner Interactions
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Manage communications with regional operating companies and regulatory authorities.
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Facilitate regulatory discussions and support local teams in preparing for authority meetings.
Regulatory Submissions
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Plan and track submission timelines, including lifecycle updates and safety reporting.
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Review critical documentation and ensure compliance with regulatory standards.
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Participate in Rapid Response Teams to address health authority inquiries.
Additional Duties
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Contribute to process development and implementation within the APAC regulatory office.
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Inform global teams of regulatory updates from the region for Life Sciences.
Required Technical Competencies & Knowledge
Regulatory Strategy
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Strong grasp of pharmaceutical development and the regulatory environment.
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Ability to interpret regional regulatory changes and influence global strategies.
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Awareness of medical, scientific, and pricing considerations for Life Sciences.
Health Authority Interactions
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Understand structure and operations of regional health authorities.
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Experience influencing regulatory decisions and supporting business needs.
Submission Management
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Deep knowledge of regional dossier requirements and documentation needs.
- Assess and align reports with regulatory strategy.
Labeling
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Familiarity with local labeling standards and competitive benchmarks.
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Support negotiations and revisions as part of the submission process.
Problem Solving
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Make informed decisions within complex regulatory contexts.
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Resolve regional priorities in collaboration with stakeholders.
Independence & Autonomy
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Operates independently with minimal supervision.
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Sets long-term objectives and resolves routine work issues effectively.
Qualifications & Skills
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Bachelor’s degree in Pharmacy, Life Sciences, or Health Sciences.
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2–8 years of relevant industry experience, ideally in regulatory roles.
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Hands-on experience with APAC product registration preferred.
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Strong organizational and communication skills.
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Ability to manage cross-functional projects in a matrixed, multicultural environment.
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Proficiency in English (and preferably Mandarin/other Asian languages).
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Occasional regional and international travel required.
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Comfort with flexible work hours to coordinate across time zones.
Keywords: Senior Regulatory Affairs Professional, APAC, Johnson & Johnson, Jobs, Regulatory Affairs, Healthcare Innovation, Regulatory Strategy, Health Authority Interactions, Regulatory Submissions. Life Sciences Regulatory Affairs Jobs at Johnson & Johnson, Apply Now!
