Regulatory Affairs Expert

4 days ago


Mumbai, Maharashtra, India Piramal Group Full time

Job Overview:

The Regulatory Affairs Expert will play a pivotal role in ensuring the compliance of pharmaceutical products with regulatory requirements. This position involves providing scientific input for new product development, reviewing and approving product claims, conducting claim substantiating studies, and collaborating with internal stakeholders to ensure successful project delivery.

Key Responsibilities:

  • Prepare Red Books for key therapeutic targets
  • Provide scientific understanding and training to relevant stakeholders
  • Evaluate claims as per regulations and technical requirements
  • Conduct research studies to support claims
  • Handle consumer and medical queries received through consumer care
  • Review FAQs to consumer care team
  • Liaise with internal stakeholders to ensure OTIF delivery of projects

Requirements:

This role requires a strong background in regulatory affairs, preferably in the pharmaceutical sector. The ideal candidate should have experience in preparing Red Books, training teams, and working on OTC drugs. Additionally, they should be well-versed with regulations such as the D&C Act, DMR Act, and UCPMP.

Salary: $120,000 - $150,000 per annum, depending on experience.



  • Mumbai, Maharashtra, India General Mills Full time

    Job Title: Regulatory Affairs Leader Job Summary: We are seeking a skilled Regulatory Affairs Leader to monitor regulatory changes and status in multiple markets, including India, the Middle East, and Southeast Asia. The successful candidate will conduct impact assessments for regulatory changes and partner with the business to build readiness plans. ...


  • Mumbai, Maharashtra, India Genpact Full time

    About the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Genpact. As a Lead Regulatory Affairs Expert, you will play a critical role in ensuring compliance with labeling regulations and guidelines.Key ResponsibilitiesLiaise with key interfaces to ensure project requirements are met and timelines are mutually...


  • Mumbai, Maharashtra, India 1925 GlaxoSmithKline LLC Full time

    Job Title: Regulatory Affairs CMC ManagerJob Summary:We are seeking a highly experienced Regulatory Affairs CMC Manager to join our team at 1925 GlaxoSmithKline LLC. The successful candidate will be responsible for managing global CMC regulatory activities, from early phase clinical through marketing applications and early lifecycle activities for multiple...


  • Mumbai, Maharashtra, India Colgate-Palmolive Company Full time

    Job OverviewThis position is responsible for handling and maintaining product compliance throughout the product lifecycle. The Regulatory Affairs Associate will work closely with the Regional Regulatory Affairs Department to ensure compliance with registration and regulatory requirements in Europe and North America.Key ResponsibilitiesSupport the regional...


  • Mumbai, Maharashtra, India Colgate-Palmolive Company Full time

    Job SummaryThis role is responsible for handling and maintaining product compliance throughout the entire product life-cycle, encompassing various product categories. The successful candidate will report to the Team Lead, Regulatory Operations.Responsibilities:Support the Regional Regulatory Affairs Department in new product registration and life-cycle...


  • Mumbai, Maharashtra, India Colgate-Palmolive Company Full time

    Colgate-Palmolive is seeking a skilled Regulatory Affairs Associate to join our team. In this role, you will be responsible for handling and maintaining product compliance during the entire product life-cycle.Key Responsibilities:Work closely with the Regional Regulatory Affairs Department to ensure compliance with regulatory requirements.Support the...


  • Mumbai, Maharashtra, India Lifelancer Full time

    We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Lifelancer in Mumbai, India. As a key member of our Regulatory Operations department, you will be responsible for ensuring compliance with regulatory requirements across various product categories.The ideal candidate will have a BS degree in Pharmacy or Life Sciences and 1+...


  • Mumbai, Maharashtra, India 1925 GlaxoSmithKline LLC Full time

    Job DescriptionAs a Regulatory Affairs Manager at 1925 GlaxoSmithKline LLC, you will be responsible for leading global CMC regulatory activities, from early phase clinical through marketing applications and early lifecycle activities for multiple projects and teams simultaneously. You will interpret and advise teams on global guidelines, procedures, and...


  • Mumbai, Maharashtra, India Piramal Group Full time

    Job Overview:The Piramal Group seeks a highly skilled Scientific Affairs Expert to join our team. As a key member of our Medical & Regulatory Affairs department, you will be responsible for providing scientific inputs for new product development, reviewing and approving product claims, conducting claim substantiating studies, conducting scientific training...


  • Mumbai, Maharashtra, India 1925 GlaxoSmithKline LLC Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at 1925 GlaxoSmithKline LLC.About the RoleAs a Regulatory Affairs Specialist, you will be responsible for ensuring the development of appropriate Precision Medicine and Digital Health regulatory strategy(s) and their execution for assigned precision medicine and digital...


  • Mumbai, Maharashtra, India SUN PHARMA Full time

    Regulatory Affairs ExecutivePosition: Executive/Sr. Executive – Regulatory Affairs (API)Responsibilities:Regulatory Compliance: Ensure compliance with regulatory requirements for API plants and corporate.Submission Guidelines: Develop and implement submission guidelines and ICH Quality guidelines.Change Control: Manage change control and related submission...


  • Mumbai, Maharashtra, India Jones Recruit Zo Full time

    Job Title: Head - Regulatory Affair - PharmaJob Description:Job Summary:The Head of Regulatory Affairs will be responsible for overseeing all regulatory aspects of our product development, manufacturing, and marketing processes. This role involves ensuring compliance with the Food Safety and Standards Authority of India (FSSAI), Legal Metrology, the...


  • Mumbai, Maharashtra, India Counselect Services Private Limited Full time

    Regulatory Affairs Role OverviewCounselect Services Private Limited is seeking a skilled Regulatory Affairs Specialist to join their team. This role involves handling the regulatory function for drugs, cosmetics, and food products in both domestic and international markets.The ideal candidate will have knowledge of regulations such as the Drugs and Cosmetics...


  • Mumbai, Maharashtra, India SUN PHARMA Full time

    Job Title: Regulatory Affairs SpecialistKey Responsibilities:Ensure compliance with regulatory requirements for API Plant operations.Manage DMF compilation and lifecycle management.Coordinate change control and related submissions.Develop and maintain quality standards.Requirements:Qualifications:Minimum 2 years of experience in regulatory affairs or quality...


  • Mumbai, Maharashtra, India 1925 GlaxoSmithKline LLC Full time

    Job Description:Career Opportunities at 1925 GlaxoSmithKline LLCThis is an exceptional opportunity to join our team as a Regulatory Affairs Director in Pharmaceutical Development. We are seeking an experienced professional to lead the development of global regulatory strategies for pharmaceutical products.Job Summary:The successful candidate will be...


  • Mumbai, Maharashtra, India Piramal Group Full time

    **Job Overview:**The Regulatory Affairs Specialist will be responsible for providing scientific inputs for new product development, reviewing and approving product claims, conducting claim substantiating studies, and collaborating with others in the organization to contribute to the success of the business.**Key Responsibilities:**Prepare Red Books for key...


  • Mumbai, Maharashtra, India Parexel Full time

    About the RoleWe are seeking a highly skilled Regulatory Affairs Consultant to join our team at Parexel.As a Regulatory Affairs Consultant, you will be responsible for handling the life cycle management of approved drug products, including tablets, syrups, and parenterals.You will lead and contribute to the planning, preparation, and delivery of regulatory...


  • Mumbai, Maharashtra, India Piramal Group Full time

    Business: Piramal Critical Care Department: Regulatory AffairsLocation: Kurla, MumbaiTravel: LowJob OverviewAs a Regulatory Affairs Specialist, you will be responsible for managing Regulatory Filings for Europe with minimal supervision.Key Stakeholders: InternalCountry manager, Plant, QA, Artwork department, Supply Chain, PVKey Stakeholders: ExternalHealth...


  • Mumbai, Maharashtra, India Chemill Pharma Ltd. Full time

    At Chemill Pharma Ltd., we are seeking an experienced Regulatory Affairs Manager to join our dynamic team. This pivotal role involves ensuring timely regulatory submissions, close coordination with manufacturers, and meticulous document management.Detailed Responsibilities:Review and evaluate assigned dossiers from manufacturers according to country-specific...


  • Mumbai, Maharashtra, India Abbott Full time

    Job Summary">We are seeking an Experienced Regulatory Affairs Manager to join our team at Abbott.About the Role">This is an individual contributor role that works under limited supervision and applies subject matter knowledge in the area of Regulatory Affairs.The ideal candidate will possess well-developed skills in directing development of product...