Regulatory Affairs Associate II Jobs in Navi Mumbai at Teva Pharmaceuticals focusing on FDA submissions, ANDA maintenance, and post approval changes
About the Company
Teva Pharmaceuticals is a global pharmaceutical leader dedicated to making good health more affordable and accessible. Operating in nearly 60 countries, Teva is the world’s leading manufacturer of generic medicines and a key producer of products listed on the World Health Organization’s Essential Medicines List. Every day, more than 200 million people worldwide rely on Teva medicines, reflecting the company’s strong commitment to global healthcare and patient well-being. Regulatory Affairs Associate II Jobs in Navi Mumbai
Teva fosters a diverse, inclusive, and collaborative work culture where professionals are empowered to grow and make a meaningful impact. Regulatory Affairs Associate II Jobs in Navi Mumbai
Job Details
- Job Title: Regulatory Affairs Associate II
- Job ID: 64918
- Location: Navi Mumbai, Maharashtra, India – 400706
- Employment Type: Full Time
- Experience Required: Minimum 4+ Years
- Department: Regulatory Affairs
Job Description
Teva Pharmaceuticals is seeking an experienced Regulatory Affairs Associate II to support FDA regulatory submissions and post-approval activities. This role involves preparing, reviewing, and submitting high-quality regulatory documentation in compliance with FDA regulations and internal timelines. Regulatory Affairs Associate II Jobs in Navi Mumbai
The Associate II will work with minimal supervision, independently evaluate post-approval change controls, and maintain regulatory databases and trackers. Annual reports, supplements, and post-approval submissions will be the primary focus of this position. Regulatory Affairs Associate II Jobs in Navi Mumbai
Key Responsibilities
- Maintain approved ANDA applications in compliance with FDA regulations
- Prepare, compile, publish, and submit ANDA Annual Reports within defined timelines
- Proactively request and collect documentation required for annual reports under minimal supervision
- Independently work on simple post-approval supplements and support management on complex supplements
- Evaluate post-approval change controls to ensure completeness, accuracy, and regulatory compliance
- Consult with management before progressing change controls when required
- Review applicable FDA post-approval guidance documents to strengthen regulatory knowledge
- Accurately populate and maintain regulatory databases, trackers, and internal systems in real time
- Train and mentor Associate I team members on internal processes, procedures, and systems when required
- Support additional regulatory projects and responsibilities as assigned
Regulatory Affairs Associate II Jobs in Navi Mumbai
Skills / Qualifications
Educational Qualification
- M.Pharm degree in Regulatory Affairs or Quality Assurance is a plus
Experience
- Minimum 4+ years of pharmaceutical industry experience
- Experience in Regulatory Affairs, Analytical, Quality Assurance, Laboratory, or Production functions preferred
Technical Skills
- Good understanding of FDA regulations and post-approval submission requirements
- Basic to intermediate computer skills, including Microsoft Word and Excel
- Familiarity with regulatory documentation workflows and compliance standards
Soft Skills
- Ability to work independently with minimal supervision
- Strong teamwork and collaboration skills
- Good verbal and written communication abilities
- Well-organized, detail-oriented, and capable of multitasking
- Ability to manage changing priorities in a dynamic regulatory environment
Benefits / Perks
- Opportunity to work with a globally recognized pharmaceutical organization
- Exposure to FDA regulatory submissions and post-approval lifecycle management
- Inclusive and diverse workplace culture
- Professional growth and long-term regulatory career development
- Stable work environment with global regulatory exposure
Regulatory Affairs Associate II Jobs in Navi Mumbai
Why You Should Join
- Be part of a mission-driven organization improving access to affordable medicines worldwide
- Gain hands-on experience with FDA submissions and ANDA lifecycle maintenance
- Work in a collaborative and knowledge-driven regulatory team
- Develop leadership and mentoring skills by supporting junior associates
- Build a strong, long-term career in Regulatory Affairs with global impact
Regulatory Affairs Associate II Jobs in Navi Mumbai
How to Apply
FAQs
Is this role suitable for mid-level regulatory professionals?
Yes, this position is ideal for candidates with 4 or more years of pharmaceutical regulatory experience.
Which regulatory authority will I primarily work with?
You will primarily handle submissions and compliance activities related to the US FDA.
Will I handle post-approval submissions?
Yes, annual reports, supplements, and post-approval change controls are key responsibilities.
Does this role involve mentoring junior team members?
Yes, Associate II may train and guide Associate I staff on processes and systems.
Is Teva an equal opportunity employer?
Yes, Teva is committed to equal employment opportunity and maintaining a diverse and inclusive workplace.
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