Regulatory Affairs Associate I Jobs at Teva Pharmaceuticals
Introduction
Teva Pharmaceuticals, a globally respected biopharmaceutical organization, is hiring a Regulatory Affairs Associate I for its Navi Mumbai location. This opportunity is ideal for regulatory professionals with foundational experience in FDA submissions and ANDA lifecycle management who want to grow within a structured, compliance-driven global environment.
The role focuses on annual report submissions, change control evaluations, and regulatory database management under FDA guidelines. If you are looking to build a long-term career in Regulatory Affairs with a global pharma leader, this position offers strong learning, stability, and growth potential. Regulatory Affairs Associate I Jobs
Company Overview
Teva Pharmaceuticals is a leading global biopharmaceutical company with a strong presence across branded, specialty, and generic medicines. The organization combines innovation in complex therapies with a world-class generics platform to deliver high-quality, affordable medicines to patients worldwide. Regulatory Affairs Associate I Jobs
With operations across multiple continents, Teva promotes a culture of collaboration, inclusion, and continuous learning. The company supports professional development while encouraging work-life balance and employee well-being, making it a preferred employer in the pharmaceutical industry. Regulatory Affairs Associate I Jobs
Job Location & Employment Type
- Job Location: Navi Mumbai, Maharashtra (400706)
- Employment Type: Full-time
- Work Mode: On-site
- Industry: Regulatory Affairs / Pharmaceutical Compliance
Open Positions / Department Details
- Position Title: Regulatory Affairs Associate I
- Department: Regulatory Affairs
- Job ID: 65573
- Career Level: Entry to Junior-Level Regulatory Professional
- Reporting: Under Regulatory Affairs Manager / Designee
This role supports regulatory submission activities related to ANDA maintenance and FDA compliance. Regulatory Affairs Associate I Jobs
Key Roles & Responsibilities
The selected candidate will work under direct supervision and contribute to regulatory submission and compliance activities. Key responsibilities include: Regulatory Affairs Associate I Jobs
- Preparing ANDA Annual Reports in accordance with FDA regulatory requirements
- Assisting in the preparation of regulatory supplements and amendments as experience increases
- Reviewing supporting documentation for change controls, including batch records, analytical methods, and specifications
- Supporting change control evaluations to ensure regulatory accuracy and compliance
- Maintaining approved applications in line with FDA regulations for assigned products
- Accurately updating and maintaining regulatory databases, trackers, and internal systems in real time
- Gaining familiarity with FDA regulations and guidance documents related to filing determinations
- Supporting additional regulatory projects and tasks as assigned by the reporting manager
- Ensuring high attention to detail, data accuracy, and documentation integrity
Eligibility Criteria
Education
- M.Pharm degree in Regulatory Affairs or Quality Assurance (preferred)
- Candidates with strong pharma regulatory exposure and relevant education may also be considered
Experience
- Minimum 2 years of experience in:
- Regulatory Affairs
- OR Analytical / Quality Control
- OR R&D / Laboratory / Production roles within the pharmaceutical or biotech industry
Skills Required
- Working knowledge of FDA regulations and ANDA lifecycle concepts
- Basic proficiency in Microsoft Word and Excel
- Ability to manage multiple tasks and shifting priorities
- Strong attention to detail and documentation accuracy
- Good written and verbal communication skills
- Ability to work both independently and within cross-functional teams
- Organized, methodical, and compliance-focused work approach
Salary & Benefits
- Salary: As per company norms and based on experience
Employee Benefits Include:
- Competitive leave and reward programs
- Flexible working arrangements (role-dependent)
- Health and wellness support programs
- Access to internal learning and career development platforms
- Opportunities for internal mobility and professional growth
- Inclusive, supportive, and employee-centric work culture
Regulatory Affairs Associate I Jobs
Selection Process
The selection process may include:
- Application Screening
- Technical / Regulatory Interview
- Managerial Discussion
- HR Interview
Final selection will be based on regulatory knowledge, experience relevance, and organizational fit. Regulatory Affairs Associate I Jobs
How to Apply
Interested candidates should apply through Teva Pharmaceuticals’ official career portal:
Applicants are advised to keep their resumes updated with regulatory submission experience and FDA-related responsibilities. Regulatory Affairs Associate I Jobs
Important Dates
- Last Date to Apply: Not specified
Why Apply for This Pharma Job?
This role offers an excellent opportunity to work on real FDA submissions and ANDA maintenance activities within a global regulatory framework. It is especially suitable for professionals who want to deepen their expertise in US regulatory affairs while working with a globally established pharmaceutical company.
Teva provides structured learning, regulatory exposure, and a clear pathway for long-term growth in Regulatory Affairs. Regulatory Affairs Associate I Jobs
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform that shares pharmaceutical and life sciences career updates for informational purposes only. We are not affiliated with Teva Pharmaceuticals or any recruiting organization. Candidates should independently verify job details and must not pay any fees for job applications or recruitment processes. Regulatory Affairs Associate I Jobs
Final Call-to-Action
If you have regulatory experience and are eager to strengthen your career in FDA and ANDA regulatory affairs, this opportunity at Teva Pharmaceuticals is worth pursuing. Apply at the earliest and take the next step toward a global regulatory career. Regulatory Affairs Associate I Jobs
