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Regulatory Affairs Associate I

2 to 3 years years
not specified
10 Sept. 5, 2025
Job Description
Job Type: Full Time Education: M.Pharm or M.Sc. (Mandatory) Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Regulatory Affairs Associate I

Job ID: 63835
Date Posted: September 3, 2025
Location: Navi Mumbai, Maharashtra, India – 400706
Company: Teva Pharmaceuticals


About Teva Pharmaceuticals

At Teva, we are on a mission to make good health more affordable and accessible, helping millions across nearly 60 countries live healthier lives. As the world’s leading manufacturer of generic medicines and a proud producer of many products on the World Health Organization’s Essential Medicines List, we impact over 200 million people every day. We are constantly striving to make a difference—with the help of passionate individuals like you.


Position Summary

The Regulatory Affairs Associate I is responsible for organizing and performing required regulatory activities to maintain existing European Union (EU) procedures in compliance with current regulations, guidelines, and internal standards. The role supports post-approval submissions and communication with relevant regulatory agencies and internal teams.


Key Responsibilities

  • Prepare, compile, review, and submit high-quality submissions for all required post-approval activities as per EU legislation and company standards.

  • Ensure Marketing Authorization (MA) compliance with current legislation and business needs.

  • Prioritize, plan, and monitor submissions for allocated procedures and update involved stakeholders on progress.

  • Secure approvals within stipulated timelines for designated projects.

  • Maintain registration documentation and electronic databases in line with internal procedures.

  • Provide regulatory support and product information to internal and external customers, stakeholders, and project teams.

  • Communicate with other Teva departments across Europe and European Regulatory Agencies regarding submissions.

  • Stay updated on current and upcoming regulatory legislation and guidelines.

  • Support other departmental duties and ad-hoc assignments as directed by Senior Regulatory Affairs personnel.


Qualifications & Experience

  • Education: M.Pharm or M.Sc. (Mandatory)

  • Experience Required:

    • 2 to 3 years in Post-approval Regulatory Affairs within the pharmaceutical industry.

    • Desirable: Experience with EU submissions and understanding of European regulatory procedures.


Skills & Competencies

  • Regulatory Knowledge:

    • Understanding of EU member state procedures and regulations (Desirable).

    • Knowledge of pharmaceutical industry processes and departments.

  • Technical Skills:

    • Computer literacy

    • Data and document analysis

  • Soft Skills:

    • Excellent oral and written communication

    • Time and organizational management

    • Attention to detail

    • Teamwork and collaboration

    • Initiative and problem-solving

    • Ability to work under pressure and meet tight deadlines

    • Negotiation and stakeholder engagement


Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal employment opportunity. We do not discriminate on the basis of age, race, religion, gender, disability, sexual orientation, gender identity or expression, veteran status, national origin, or any other protected status. We foster a diverse and inclusive workplace and ensure accessibility throughout the recruitment process. Please inform us of any accommodations needed during the selection process.