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Regulatory Affairs Specialist

8-12 years
Not Disclosed
10 Jan. 4, 2025
Job Description
Job Type: Full Time Education: MSc/M.Pharm 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

Company Overview

Dr. Reddy’s Laboratories Ltd. is a global leader in pharmaceuticals, with a mission to accelerate access to affordable and innovative medicines under the credo Good Health Can’t Wait. Founded in 1984, it has expanded from 20 employees to over 24,000, with operations in 66 countries. The company integrates deep scientific expertise with sustainability, diversity, and innovation to deliver affordable healthcare solutions. By 2030, it aims to reach over 1.5 billion patients worldwide.

As an equal opportunity employer, Dr. Reddy’s fosters a diverse and inclusive work environment that values talent, merit, and innovation, while maintaining the highest ethical standards.


Role: Regulatory Affairs Specialist – Europe Submissions

Objective:
To manage and ensure compliance in regulatory dossier preparation, submission, and approvals for the European market, while collaborating with regulatory authorities and internal teams.


Key Responsibilities

  • Regulatory Submissions:

    • Prepare, review, and submit new applications for EU markets via DCP, MRP, and NP pathways.
    • Develop and maintain Module 1 documentation aligned with Modules 2–5.
    • Coordinate and ensure compliance for product artwork and information.
  • Stakeholder Engagement:

    • Build and maintain relationships with EU regulatory authorities.
    • Provide regulatory guidance and strategies to IL partners and cross-functional teams.
  • Compliance and Communication:

    • Handle regulatory deficiencies and provide timely responses to agencies.
    • Support manufacturing sites during regulatory audits.
  • Goal Achievement:

    • Monitor and follow up on product filings to ensure timely approvals.
    • Meet registration targets with minimal supervision.
  • Knowledge Sharing and Process Improvement:

    • Stay updated on EMA guidelines and participate in industry associations.
    • Create and revise SOPs to reflect regulatory updates.

Qualifications

  • Educational Background:
    M.Sc. or M.Pharma in Pharmaceutical Sciences or related fields.

  • Experience:
    8–12 years in regulatory affairs, with a focus on European registrations, including Module 1 documentation.

  • Technical Skills:

    • Strong knowledge of EMA guidelines.
    • Proficiency in regulatory dossier preparation and submission pathways (DCP, MRP, NP).
  • Behavioral Skills:

    • Excellent communication and interpersonal skills.
    • Detail-oriented with strong organizational abilities.
    • Proficiency in Google Applications and MS Excel.

Department Overview

The Integrated Product Development Organization combines cutting-edge technology and deep scientific expertise to deliver innovative, accessible therapies. With end-to-end capabilities in API, formulations, clinical trials, intellectual property, and regulatory affairs, the organization serves 55+ markets globally.


Benefits

Dr. Reddy’s offers competitive benefits, including:

  • Relocation and joining support.
  • Comprehensive family support (maternity/paternity benefits).
  • Medical and life insurance coverage.
  • Learning and development opportunities tailored to career growth.

Work Culture

At Dr. Reddy’s, our guiding principle, Good Health Can’t Wait, inspires a culture of empathy, dynamism, and collaboration. We empower our employees to innovate and make meaningful contributions to healthcare.

For more details, visit the Dr. Reddy’s Careers Website.