Teva Pharmaceuticals hiring Regulatory affairs Associates II

Regulatory Affairs Jobs in Navi Mumbai | Teva Pharmaceuticals Hiring Pharmacy Graduates with 4-6 Years Experience

Apply now for Regulatory Affairs Associate II at Teva Pharmaceuticals, Navi Mumbai. Ideal for M.Pharm or Life Sciences graduates with 4–6 years of regulatory experience in EU submissions.

 Regulatory Affairs Career Opportunity at Teva Pharmaceuticals, Navi Mumbai

Teva Pharmaceuticals, a global leader in generics and biopharmaceuticals, is looking for skilled professionals to join as Regulatory Affairs Associate II at its Navi Mumbai location. This role is well-suited for candidates with 4–6 years of regulatory affairs experience, especially those familiar with EU post-approval submissions.

If you’re passionate about compliance, strategic submissions, and working across global regulatory frameworks, this is your chance to join a purpose-driven organization that impacts over 200 million lives daily.

Position Details: Regulatory Affairs Associate II

Key Responsibilities:

• Develop US labeling documents to align with company goals and submission requirements for assigned ANDAs and/or 505(b)(2)s, if required, and ensure labeling meets all legal and regulatory requirements. This includes QC, proofing, editing, and formatting of documents, and coordinating the review and approval of final submission documents
• Develop US labeling documents needed for early development projects requiring a human factor or comparative analysis study and ensure established labeling meets all legal and regulatory requirements. This includes QC, proofing, editing, and formatting of documents, and coordinating the review and approval of final submission documents with all relevant departments
• Some experience in developing labeling content that requires carve-outs due to protected language associated with patents/exclusivities
• Establish and maintain SPL for assigned projects. Ensure product data elements align with the required drug listing regulations and established SPL is submitted through FDA’s Electronic Submission Gateway
• Prepare and electronically compile full responses to the FDA via the appropriate filing mode. This includes, but is not limited to, the development of side-by-side comparisons, SPL, and other required submission materials, as necessary
• Perform quality reviews of labeling and submission documents by proofreading established files for content accuracy, either manually or by utilizing the electronic proofreading tool TVT
• Work closely with external departments, including CMC and the Device team, to align with internal product/device strategy and process
• Work closely with Regulatory Operations, as well as in Teva’s publishing software, to ensure assigned projects are submitted on time following the eCTD requirements related to labeling
• Support products falling under Business Development deals, if required, from a labeling/artwork and drug listing perspective
• Attend assigned project meetings to ensure labeling timelines are met
• Maintain an accurate project tracker of all assigned projects with identified due date priorities and timelines of initial assignment, initiation, and completion of projects
• Maintain knowledge of US regulations, guidelines, and standard operating procedures applicable to US Gx labeling
• Work in a team environment with minimal supervision
• Perform all other job-related duties as required by management and dictated by process changes

Eligibility Criteria

• Bachelor’s in pharmacy/master’s in science & Life sciences – 4-5 Years in the Pharmaceutical Industry
• Master’s in pharmacy – 3-4 Years in the Pharmaceutical Industry
• Proven experience in regulatory affairs within the pharmaceutical, biotechnology, or medical device industry
• Be able to multi-task in a fast-paced work environment
• Have exemplary oral and written communication skills
• Be organized with keen attention to detail
• Have the ability to work independently as well as in a team environment with minimal supervision
• Have knowledge of US FDA regulations and guidance related to US Gx labeling
• Have knowledge of US FDA regulations and guidance related to US drug listing
• Have knowledge of US FDA eCTD submission standards and experience in applying these requirements to routine labeling submissions to the FDA
• PC, Microsoft Office Suite with a proficiency in Microsoft Word and Microsoft Excel
• Adobe Acrobat Professional is a must
• Familiarity with TVT preferred

📍 Job Location

• Teva Pharmaceuticals, Navi Mumbai, Maharashtra, India 400706

📆 Application Process

• Job ID: 62743
• Application Link: Click to Apply

Teva is committed to diversity and equal opportunity employment. All qualified applicants are encouraged to apply.

Quick Reference Table

Teva’s Equal Employment Opportunity Commitment

At Teva Pharmaceuticals, equal opportunity in employment is a global policy. The company values diversity, inclusivity, and accessibility, ensuring a workplace free from discrimination based on various factors. Accommodations are provided to support candidates throughout the recruitment and selection process.

How to Apply

Are interested about teva pharmaceuticals regulatory affairs associate role, Apply here