Manager – International Regulatory Lead
Location: Hyderabad, India (On-site)
Job ID: R-232877
Category: Regulatory Affairs
Posted Date: February 02, 2026
Employment Type: Full-Time
A leading global biopharmaceutical organization is seeking a Manager – International Regulatory Lead (IRL) to join its Regulatory Affairs function in Hyderabad. This strategic role provides regulatory leadership and subject matter expertise across multiple international markets for one or more products within the company’s portfolio.
The International Regulatory Lead Manager plays a critical role in shaping and executing international regulatory strategies, supporting global development programs, and enabling timely product registrations and lifecycle management across international regions.
Provide regulatory guidance to Global Development and Commercial teams on international regulatory requirements and implications across the product lifecycle.
Develop and execute international regulatory strategies to optimize clinical development, marketing authorization applications, and lifecycle management activities.
Advise on international regulatory mechanisms to accelerate development and approvals, including First-in-Human studies, orphan drug pathways, expedited designations, regulatory reliance, compassionate use, and pediatric plans.
Plan and support regulatory submissions under general supervision, including clinical trial applications, marketing authorization applications, and post-approval variations.
Contribute to international regulatory strategy documents, including filing plans, risk assessments, contingency strategies, and likelihood-of-success evaluations.
Author, review, and maintain clinical and regulatory documentation (excluding CMC) to support regulatory filings.
Lead international labelling submission strategies and manage label negotiation activities in collaboration with cross-functional teams.
Own and manage label deviation requests and outcomes across international markets.
Support local regulatory teams by triaging health authority questions and identifying precedent responses using knowledge management systems.
Serve as an active member of the Global Regulatory Team and other global clinical, labelling, and development forums.
Share regulatory intelligence and international considerations with global and regional stakeholders on an ongoing basis.
Partner with regional and local regulatory peers to align on product strategy, submission timelines, and approval expectations.
Build and maintain strong working relationships across global, regional, and local Regulatory Affairs organizations.
Monitor emerging legislation, regulatory policies, and technical guidance relevant to international markets.
Conduct regulatory research to support product advancement, including precedent analysis and regional regulatory history.
Educational Background:
Doctorate degree with 8+ years of relevant international or regional regulatory experience, or
Master’s degree with 9+ years of relevant regulatory experience, or
Bachelor’s degree with 10+ years of relevant regulatory experience.
Professional Experience:
Extensive experience within international regulatory environments supporting biotechnology and/or oncology products.
Proven experience managing clinical trial applications, marketing authorization applications, product variations, and labelling activities across multiple international markets.
Must-Have Skills:
Strong knowledge of international regulatory frameworks for clinical trials, marketing applications, post-approval variations, and product labelling.
Comprehensive understanding of regulatory principles and their impact on global development and commercialization strategies.
Working knowledge of registration procedures and regulatory challenges across international markets for clinical development and lifecycle management.
Good-to-Have Skills:
Strong problem-solving skills with the ability to resolve conflicts and drive optimal regulatory outcomes.
Cultural awareness and sensitivity to effectively collaborate across regional and international boundaries.
Excellent written and verbal communication skills.
Ability to interpret and clearly communicate complex scientific and clinical information.
Proven capability to work effectively within global, regional, local, and virtual teams.
High level of initiative, self-motivation, and accountability.
Strong planning, organization, and prioritization skills.
Ability to manage multiple, complex regulatory priorities simultaneously.
Collaborative, team-oriented mindset with strong negotiation and influencing capabilities.
The organization is an Equal Opportunity Employer and is committed to fostering a diverse and inclusive workplace. Qualified applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability. Reasonable accommodations are available throughout the recruitment process.
Apply via thepharmadaily.com to advance your regulatory career and contribute to the successful global development and approval of innovative biopharmaceutical products.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Netherlands |Remote Australia :
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Queensland |Melbourne :
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Uxbridge | Renfrew | Richmond Hill | Australia | North York | Mississauga |Canada :
Canada |Quebec :
Montreal |Brussels :
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Peru | Argentina |Brazil :
Brazil | Sao paulo |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
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Hà Nội | Hanoi |Ho Chi Minh :
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Japan | Saitama |Tokyo :
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Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
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Midrand | South Africa |Nišava District :
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Prague |Chile :
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