Teva Pharmaceuticals is hiring Associate II, Regulatory Affairs in Bangalore. Apply now for sterile product regulatory submissions and compliance.
Location: Bangalore, India
Company: Teva Pharmaceuticals
Job Type: Full-time
Experience Required: 4+ Years
About Teva Pharmaceuticals
Teva Pharmaceuticals is a global leader in generic medicines and specialty pharmaceuticals, recognized for developing high-quality, affordable medicines that improve patient access worldwide. With a strong focus on complex generics, biosimilars, and sterile formulations, Teva plays a crucial role in transforming healthcare through innovation, compliance, and regulatory excellence. Teva Pharma Hiring for Associate II Regulatory Affairs
With operations in more than 60 countries and products available to millions of patients globally, Teva offers a collaborative work culture, career growth opportunities, and exposure to cutting-edge regulatory practices.
If you are passionate about ensuring medicines meet regulatory standards while shaping the future of affordable healthcare, this role is ideal for you.
Job Title
Associate II – Complex Generics, Regulatory Affairs
Location
Bangalore, India
Employment Type
Full-time, Onsite
Experience Level
Mid-level (4+ years)
Required Qualifications
Candidates applying for this role must fulfill the following criteria: Teva Pharma Hiring for Associate II Regulatory Affairs
| Qualification | Requirement |
|---|---|
| Education | Master’s degree in Regulatory Affairs, Quality Assurance, or Pharmacy |
| Industry Experience | Minimum 4+ years of pharmaceutical industry experience |
| Product Expertise | Strong exposure to sterile product development (preferred) |
| Regulatory Knowledge | In-depth understanding of FDA and ICH guidelines |
| Skills | Excellent communication, organizational, and critical thinking abilities |
Key Responsibilities
As an Associate II in Regulatory Affairs (Complex Generics), you will be responsible for ensuring compliance with global regulatory standards, particularly US FDA requirements, for sterile products and complex generics. Your day-to-day responsibilities will include: Teva Pharma Hiring for Associate II Regulatory Affairs
- Regulatory Submissions: Preparing, reviewing, and compiling regulatory dossiers, amendments, and deficiency responses (IRs, DRLs, CRLs).
- FDA Engagement: Supporting early interactions with FDA to align on development strategies and reduce regulatory risks.
- Regulatory Assessments: Conducting impact assessments for major changes such as site transfers and alternate API sourcing.
- Cross-functional Collaboration: Acting as the regulatory point of contact for R&D, Quality Assurance, Manufacturing, and DMF holders.
- Timeline Monitoring: Proactively identifying and addressing document gaps to ensure timely regulatory submissions.
- Change Control Evaluation: Assessing regulatory pathways (PAS, CBE-30, CBE-0, AR) for manufacturing or process changes.
- Post-approval Compliance: Filing supplements and variations to maintain compliance with FDA, ICH, and internal quality standards.
- Regulatory Intelligence: Monitoring updates in FDA databases such as Orange Book and Drugs@FDA.
- Audit Participation: Supporting regulatory audits, inspections, and internal process improvement initiatives.
Why Join Teva Pharmaceuticals?
Teva Pharmaceuticals offers an inclusive, collaborative, and innovative environment for regulatory professionals. By joining the team, you will benefit from: Teva Pharma Hiring for Associate II Regulatory Affairs
- Global Exposure: Work with cross-functional international teams across regulatory, R&D, and manufacturing.
- Specialized Focus: Hands-on experience in sterile formulations and complex generics, a growing segment in global healthcare.
- Career Growth: Access to structured training, mentorship, and global career advancement opportunities.
- Workplace Culture: Inclusive, supportive, and committed to equal employment opportunities.
- Impactful Contribution: Be part of a mission that enhances affordable healthcare accessibility worldwide.
Skills Required
To excel in this role, you should possess:
- Strong regulatory writing and submission expertise.
- Ability to interpret and apply FDA/ICH guidelines effectively.
- Knowledge of sterile manufacturing processes and challenges.
- Analytical and logical thinking for regulatory assessments.
- Effective communication to align with stakeholders and global teams.
- Organizational skills to manage multiple submissions and timelines simultaneously.
Preferred Experience
While not mandatory, the following experiences will give candidates an added advantage: Teva Pharma Hiring for Associate II Regulatory Affairs
- Experience in sterile injectable or ophthalmic product development.
- Prior regulatory interactions with the US FDA.
- Hands-on involvement in ANDA, NDA, or 505(b)(2) submissions.
- Familiarity with DMFs, CMC documentation, and lifecycle management.
Career Path at Teva
The Regulatory Affairs team at Teva plays a strategic role in ensuring that products meet compliance requirements while reaching the global market efficiently. Professionals starting as Associate II can progress to roles such as: Teva Pharma Hiring for Associate II Regulatory Affairs
- Associate III / Senior Associate – Regulatory Affairs
- Manager – Regulatory Affairs
- Regulatory Affairs Lead (Global Submissions)
- Director – Regulatory Strategy
Salary and Benefits
While Teva maintains a competitive salary structure based on experience and qualifications, candidates can expect:
- Attractive compensation package.
- Performance-based incentives.
- Health and wellness benefits.
- Retirement and insurance plans.
- Professional development and global training programs.
Application Process
Interested candidates can apply online through Teva’s official career portal. Ensure your CV highlights: Teva Pharma Hiring for Associate II Regulatory Affairs
- Experience in FDA submissions.
- Exposure to sterile formulations.
- Familiarity with regulatory databases and post-approval submissions.
- Strong communication and leadership contributions in regulatory projects.
About the Regulatory Affairs Team
The Regulatory Affairs team at Teva ensures compliance and drives regulatory strategy for complex generics and sterile products. The team works closely with R&D, Quality, Manufacturing, and Global Regulatory Authorities to accelerate product approvals and maintain compliance throughout the product lifecycle. Teva Pharma Hiring for Associate II Regulatory Affairs
Joining this team means you will not only contribute to Teva’s success but also play a vital role in ensuring patients worldwide have timely access to affordable medicines.
Why Regulatory Affairs in Complex Generics?
Complex generics require a higher level of regulatory expertise due to their formulation intricacies, sterile manufacturing processes, and stringent quality standards. Working in this space provides: Teva Pharma Hiring for Associate II Regulatory Affairs
- Exposure to cutting-edge technologies.
- A chance to influence regulatory strategy and global submissions.
- Experience in navigating challenges with FDA and ICH guidelines.
- Opportunities to contribute to life-saving medicines.
Final Thoughts
This is an exciting opportunity for regulatory professionals seeking to advance their careers with a world leader in generics. If you have a strong regulatory background, especially in sterile formulations, and wish to work in a globally recognized pharmaceutical company, Teva Pharmaceuticals offers the right platform for you. Teva Pharma Hiring for Associate II Regulatory Affairs
How to Apply
To apply for the position of Associate II, Regulatory Affairs (Complex Generics) at Teva Pharmaceuticals in Bangalore, click the link below:
