Location: Bangalore, India, 560094
Company: Teva Pharmaceuticals
Job ID: 65569
Experience Required: 10+ years in Regulatory Affairs, APAC region experience preferred
Job Category: Regulatory Affairs / Pharmaceutical Compliance
Job Type: Full-Time, Permanent
About Teva Pharmaceuticals
Teva Pharmaceuticals is a global leader in biopharmaceuticals and generic medicines, dedicated to delivering high-quality healthcare solutions worldwide. Operating across nearly 60 countries, Teva drives innovation in generics, biosimilars, and specialty medicines while ensuring patient safety and regulatory compliance. Our culture values collaboration, professional growth, and global exposure, empowering employees to make a meaningful impact on healthcare.
Role Overview
The Manager – Regulatory Affairs, APAC will oversee regulatory submissions, product maintenance, and compliance activities for Teva’s products across Australia, New Zealand, Singapore, Malaysia, and other APAC markets. This role ensures regulatory compliance, supports new product launches, and provides strategic regulatory guidance to cross-functional teams to enable business growth in the region.
Key Responsibilities
Regulatory Submissions & Compliance
Manage submissions, post-approval changes, and maintenance activities for Branded, Specialty, and Generic products in APAC.
Ensure full regulatory compliance of marketed products through proactive change control, site transfers, and coordination with global RA teams.
Maintain regulatory data in systems including GRIDS, GI Insights, Teva Art, and Veeva.
Support new product launches by coordinating regulatory requirements, artwork approvals, and technical input for market introduction.
Regulatory Guidance & Intelligence
Provide regulatory guidance to ensure Teva meets responsibilities as importer, distributor, and sponsor in APAC markets.
Monitor, interpret, and communicate APAC regulatory guidelines and trends to commercial and cross-functional teams.
Maintain comprehensive regulatory records for ready retrieval and lifecycle management.
Collaborate with APAC market RA teams to complete regulatory tasks efficiently.
Capture RA activities and prepare monthly reports for leadership and global tracking systems.
Strategic Support
Advise internal teams on regulatory strategies for product compliance and lifecycle management.
Support continuous improvement in regulatory processes and compliance across APAC.
Ensure timely and accurate execution of all regulatory tasks, aligned with business priorities.
Required Qualifications & Experience
B. Pharm or M. Pharm (preferred) in a relevant scientific discipline.
Minimum 10+ years of experience in Regulatory Affairs within the pharmaceutical industry.
Proven expertise in Generics, Biosimilars, or Innovative Medicines, preferably in the APAC region.
Strong knowledge of APAC regulatory frameworks, including Australia, New Zealand, Singapore, and Malaysia.
Experience in product registration, regulatory submissions, and post-approval lifecycle management.
Proficiency with regulatory systems and compliance tools.
Excellent analytical, communication, and stakeholder management skills.
Ability to work in a global, matrixed organization with cross-functional teams.
Reporting
Reports to Head of Regulatory Affairs, APAC.
Why Teva?
Competitive benefits including flexible working schedules, health support, and generous leave policies.
Career development opportunities through Twist, Teva’s platform for learning programs, short-term projects, and internal mobility.
Inclusive, collaborative culture encouraging professional development, global exposure, and employee wellbeing.
Equal Opportunity Employer
Teva Pharmaceuticals is committed to equal employment opportunity. Employment decisions are made without regard to age, race, religion, gender, disability, sexual orientation, or any legally protected status. Teva fosters diversity, inclusion, and accessibility throughout recruitment and provides confidential accommodations to ensure an accessible candidate experience.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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amritsar | Bathinda | Bela | Chandigarh | ludhiana | Moga | Mohali | Patiala | Phagwara | Rajpura |Andra Pradesh :
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Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Madhya Pradesh :
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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | India | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
Digha | Kolkata | Mukundapur |Goa :
Goa | Panaji | Verna |Bihar :
Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
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