PHARMAFull-time
Regulatory Affairs Associate II
MUMBAI (IN)ONSITEPOSTED: 9/28/2026
PHARMAFull-time
HIRING ORGANIZATIONTEVA PHARMACEUTICALSBiopharmaceuticals / Life Sciences
ROLE OVERVIEW
Regulatory Affairs Associate II responsible for preparing, reviewing and submitting high-quality FDA regulatory submissions, managing post-approval change controls, maintaining regulatory databases and supporting ANDA annual reports and supplements.
ROLE DEFINITION & RESPONSIBILITIES
- •Maintain approved applications in compliance with FDA regulations for assigned ANDA annual reports
- •Request and compile documentation required for annual reports and prepare materials for management review
- •Independently work on simple supplements and support management on complex supplements
- •Evaluate post-approval change controls for regulatory impact and completeness
- •Review applicable FDA post-approval guidance and regulations
- •Maintain regulatory databases and team trackers accurately and in real time
- •Train Associate I employees on internal processes, procedures, databases and trackers when required
- •Perform other assigned regulatory projects and duties
Reporting Hierarchy: Reports to Regulatory Affairs management or designated manager; Works independently with moderate to minimal guidance and collaborates with regulatory and cross-functional teams
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Minimum four years plus of pharmaceutical industry experience
- Regulatory, analytical, QA, laboratory or production experience preferred
- Ability to prepare and review regulatory submissions
- Basic computer skills including Word and Excel
- Ability to work independently and collaboratively
- Strong verbal and written communication skills
- Strong organization, attention to detail and multitasking ability
PREFERRED QUALIFICATIONS
- •M. Pharma degree in Regulatory Affairs or Quality Assurance
- •Experience with ANDA annual reports and post-approval supplements
- •Experience with FDA regulatory requirements and post-approval guidance
- •Experience training junior regulatory associates
REQUIRED VERIFIED SKILLS
FDA regulations
ANDA
regulatory submissions
post-approval changes
annual reports
supplements
change controls
regulatory databases
compliance
pharmaceutical regulations
Word
Excel
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Medical insurance, OPD coverage, annual health checkups, term life and accident insurance, employee assistance program, healthy meals at work, wellbeing initiatives, volunteering programs, continuing education and mentorship
No salary or bonus information is disclosed in the provided job posting. Compensation should therefore be evaluated from the employer's formal offer and applicable local market context rather than inferred from the posting.
ORGANIZATION CONTEXT & CULTURE
Teva Pharmaceuticals is a global biopharmaceutical company with a major generics business and innovative medicines activities in areas including neuroscience and immunology.
TEAM SIZE: 50,000+ employees
INDUSTRY: Biopharmaceuticals / Life Sciences
Culture: Teva describes a people-first, inclusive and collaborative culture focused on patient needs, professional growth, global teamwork and continuous learning.
EXPECTED CAREER ROADMAP
Progression can include Senior Regulatory Affairs Associate or specialist responsibilities, followed by broader regulatory project ownership and potential management-track opportunities within global Regulatory Affairs.
APPLICATION ADVISORY
Highlight four-plus years of relevant pharmaceutical experience; demonstrate knowledge of FDA regulations, ANDA annual reports and post-approval submissions; emphasize change-control assessment and regulatory documentation experience; show strong attention to detail and ability to work independently; mention experience with regulatory databases and Excel.
RECOMMENDED TRAINING
1/5
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