PHARMAFull-time
Regulatory Affairs Associate II
By Admin · Regulatory Affairs
MUMBAI (IN)ONSITEPOSTED: 10/6/2026
PHARMAFull-time
HIRING ORGANIZATIONTEVA PHARMACEUTICALSBiopharmaceuticals / Life Sciences
ROLE OVERVIEW
Teva Pharmaceuticals is hiring a Regulatory Affairs Associate II in Navi Mumbai for work involving FDA submissions, post-approval changes, annual reports and regulatory documentation. The role is intended for candidates with at least four years of pharmaceutical industry experience and relevant regulatory, analytical, quality, laboratory or production exposure.
ROLE DEFINITION & RESPONSIBILITIES
- •Maintain assigned ANDA applications in accordance with FDA requirements
- •request and compile documentation for annual reports
- •prepare simple supplements for management review
- •assist with complex supplements
- •assess post-approval change controls using applicable FDA guidance
- •maintain regulatory databases and trackers
- •train Associate I employees on internal processes and systems when required
Reporting Hierarchy: The Associate II is expected to consult the manager or designated person before progressing change controls and works under management direction for assigned supplements.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Minimum 4+ years of pharmaceutical industry experience
- Regulatory, Analytical, Quality Assurance, laboratory or production experience preferred in the posting
- basic computer skills including Word and Excel
- ability to work independently and in teams
- good verbal and written communication
- strong organization, attention to detail, multitasking and changing-priority management
PREFERRED QUALIFICATIONS
- •M. Pharma degree in Regulatory Affairs/Quality Assurance discipline
REQUIRED VERIFIED SKILLS
FDA regulations
Regulatory submissions
ANDA
Annual reports
Supplements
Post-approval changes
Change controls
Word
Excel
Regulatory databases
Trackers
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
ORGANIZATION CONTEXT & CULTURE
Teva Pharmaceuticals is a biopharmaceutical company with a business covering innovative medicines and generic pharmaceuticals, including work in neuroscience and immunology.
INDUSTRY: Biopharmaceuticals / Life Sciences
Culture: The posting describes an inclusive workplace with collaboration, flexibility and development support.
EXPECTED CAREER ROADMAP
The role includes opportunities to gain experience with more complex supplements and to train Associate I employees on internal processes when required.
APPLICATION ADVISORY
Candidates should emphasize their four or more years of pharmaceutical industry experience and any direct Regulatory, Analytical, QA, laboratory or production experience. Experience with FDA-related submissions, ANDA annual reports, supplements, change controls and regulatory databases should be clearly highlighted, along with Word, Excel, communication and documentation skills.
RECOMMENDED TRAINING
1/5
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