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Senior Regulatory Affairs AssociateParexel · Serilingampalli, Telangana, India
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Parexel

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Senior Regulatory Affairs Associate

🗓️ Posted 2026-09-01 Serilingampalli, Telangana, India Full-time Hybrid Healthcare Medical
💰 Salary Not shared 📊 Market ₹60,000–₹100,000/mo

About the Company

Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world's life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our 22,000+ global employees work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind - broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare's most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients - With Heart. We continue to earn recognition industrywide, including the 2025 Scrip Award for "Best Contract Research Organization - Full-Service Provider," 2024 Fierce Biotech CRO Award for "Innovative Approaches to Patient-Centric Research" and the 2024 and 2023 Society for Clinical Research Sites Eagle Award. Community Guidelines Because Parexel's social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: Abusive, harassing or threatening to others. Defamatory, offensive, obscene, vulgar or depicting violence. Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. Sexually explicit or pornographic. Fraudulent, deceptive, libelous, misleading or unlawful. Referencing criminal or illegal activity. Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page. Pharmaceutical Manufacturing Specialties: Regulatory and product development consulting, early phase clinical research, phase II-III clinical research, late phase clinical research, eClinical solutions, patient and site recruitment, medical device consulting, clinical research organization, pharmacovigilance, biotechnology, biotech, market access

Responsibilities

  • ● + years experience in handling life cycle management of approved drug products (small molecules as well as biologicals including Vaccines, monoclonal antibodies) in various markets.
  • ● Good understanding of regulatory framework, including regional trends, for various types of applications and procedures
  • ● Contribute to preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions from either a global and/or regional perspective.
  • ● Working knowledge of EU/US regulatory procedures including post approval requirements.
  • ● Good understanding of regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions as well as knowledge of global pharmaceutical legislation and guidance specifically linked to regulatory CMC aspects in the ICH countries.
  • ● Authoring and review of CMC component of Marketing Authorization Applications & Variations for various types of medicinal products (orals & parenteral) for filing in EU through different types of procedures (DCP/MRP/National Procedures).
  • ● Preparation of documentation for different types of Variation procedures like Super Grouping,
  • ● Grouping and Work-sharing to the Marketing Authorizations.
  • ● Regulatory review of DMFs, batch records, specifications, and stability data to ensure their compliance with the regulatory requirements.
  • ● Author CMC components of Annual Reports and renewals (m 1/2/3), GMP submissions e.g., site registrations
  • ● Providing regulatory impact assessment for any change control and identification of required documentation for EU/US submissions and other markets.
  • ● Liaise closely with cross-functional members with aligned product responsibilities.
  • ● Execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
  • ● To prepare, review and submit safety variations to Health Authorities and perform post Approval CMC related updates.
  • ● Working experience in Regulatory Information Management Systems (RIMS) like Veeva Vault.
  • ● Strong communications skills and ability to guide and mentor team members, and ability to work independently.
  • ● Authoring content of the label (EU, Canada, AU/NZ & US) based on Company Core Data Sheet (CCDS) / PRAC / CMDH recommendations.
  • ● Familiarity with EU Guidelines for QRD / Excipients.