Regulatory Affairs Manager, CMC

4 weeks ago


Mumbai, Maharashtra, India 1925 GlaxoSmithKline LLC Full time
Job Summary

We are seeking a highly skilled CMC Regulatory Affairs Manager to join our team at 1925 GlaxoSmithKline LLC. As a key member of our regulatory affairs department, you will be responsible for managing global CMC regulatory activities, from early phase clinical through marketing applications and early lifecycle activities for multiple projects and teams simultaneously.

Key Responsibilities
  • CMC Strategy Development: Develop and implement CMC regulatory strategies to support the development and registration of new pharmaceutical products.
  • Regulatory Document Preparation: Prepare and author technical (CMC) regulatory documents to support development/registration/lifecycle maintenance submission content, in accordance with the applicable regulatory & scientific standards.
  • Risk Management: Identify risks to the business associated with submission data and information packages and provide and communicate well-defined risk mitigation strategies.
  • Team Leadership: Mentor or train staff, and may have direct line management responsibility for managing project activities for multiple complex projects and teams simultaneously.
  • Subject Matter Expertise: Engage and may lead CMC Subject Matter Expert activities and typically has deep/specialized area of expertise, both internally (for increased compliance, harmonization and efficiency) and externally (external advocacy and shaping the regulatory environment).
  • Regulatory Strategy: Deliver CMC regulatory strategy to support major inspections (eg PAIs) or quality incidents (PIRCs).
  • Submission Content: Has accountability for submission content. Understands, interprets and advises on regulations, guidelines, procedures and policies relating to development, registration and manufacturing of biopharmaceutical products.
  • Regulatory Processes: Formulates novel approaches and influences people, evaluating/improving CMC Regulatory processes, policies and systems to enhance the efficiency and quality of departmental work.
  • Communication: Directs and communicates complex regulatory issues independently across the company and with external agencies and third parties as necessary, to influence CMC project and policy issues that are aligned with business needs.
Requirements
  • Education: Bachelor's degree.
  • Experience: 6 + years of regulatory affairs experience.
  • Skills: Drug development and manufacturing and supply processes, negotiating with regulatory agencies, industry bodies, and internal colleagues in a variety of settings, filing activities (MAA/NDA/BLA, significant manufacturing change or key development interactions at EOP2/prePhase 3 or other regulatory interactions in early development).

We are an equal opportunity employer and welcome applications from diverse candidates. Please visit our website to learn more about our comprehensive benefits program.



  • 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 1925 GlaxoSmithKline LLC Full time

    Job DescriptionAs a Regulatory Affairs - Chemistry, Manufacturing and Controls (CMC) Manager at 1925 GlaxoSmithKline LLC, you will be responsible for overseeing global CMC regulatory activities, from early phase clinical through marketing applications and early lifecycle activities for multiple projects and teams simultaneously.Key ResponsibilitiesDrives the...


  • 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 1925 GlaxoSmithKline LLC Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Manager to join our team at 1925 GlaxoSmithKline LLC. As a key member of our regulatory affairs team, you will be responsible for managing global CMC regulatory activities, from early phase clinical through marketing applications and early lifecycle activities for multiple projects and teams...


  • Mumbai, Maharashtra, India Sun Pharma Advanced Research Company Ltd. Full time

    Job Summary:Sun Pharma Advanced Research Company Ltd. is seeking a highly skilled Regulatory Affairs Specialist to support the development and execution of regulatory strategies for our pharmaceutical products. The ideal candidate will have a strong background in CMC regulatory affairs and excellent communication skills.Key Responsibilities:Authoring CMC...


  • Mumbai, Maharashtra, India 1925 GlaxoSmithKline LLC Full time

    About the Role:We are seeking a highly skilled Project Manager, CMC Regulatory Affairs to join our team at GSK. As a key member of our regulatory affairs team, you will be responsible for ensuring the successful development and submission of CMC regulatory documents for our investigational and commercial products.Key Responsibilities:Develop and implement...


  • 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

    Job OverviewPiramal Pharma Solutions is seeking a highly skilled Regulatory Affairs professional to join our Corporate Regulatory Affairs team. As a key member of our team, you will be responsible for ensuring compliance with regulatory requirements and guidelines for our products in the US, EU, and Canada.Key ResponsibilitiesCompilation and submission of...


  • 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

    Business: Piramal Pharma Solutions Department: Corporate Regulatory Affairs Job OverviewWe are seeking a skilled Regulatory Affairs Specialist to join our Corporate Regulatory Affairs team at Piramal Pharma Solutions. In this role, you will be responsible for submitting regulatory dossiers for targeted markets as per business needs to support CDMO and Agile...


  • Mumbai, Maharashtra, India Piramal Group Full time

    Business: Piramal Pharma SolutionsDepartment: Corporate Regulatory AffairsLocation: GlobalTravel: LowJob OverviewSubmission of regulatory dossiers for targeted markets as per business needs to support CDMO and Agile businesses.Key Stakeholders: InternalSites – Pithampur, Lexington, Morpeth, PPDS-Ahmedabad, Mumbai R&D, Digwal, Supply Chain, Finance, Shared...


  • Mumbai, Maharashtra, India Piramal Group Full time

    Job OverviewAs a key member of the Corporate Regulatory Affairs team at Piramal Pharma Solutions, you will be responsible for the submission of regulatory dossiers for targeted markets as per business needs to support CDMO and Agile businesses. This role requires a strong understanding of regulatory requirements and guidelines, as well as excellent...


  • 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 Piramal Group Full time

    Job Title: Regulatory Affairs Specialist Job Summary: We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Piramal Critical Care. The successful candidate will be responsible for managing regulatory filings for Europe, ensuring compliance with eCTD requirements, and providing support to the Pharmacovigilance team. Key...


  • 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 Kenvue Full time

    JOB TITLEAssociate Manager, Regulatory AffairsROLE DESCRIPTIONAs a key member of our Regulatory Affairs team at Kenvue, you will play a critical role in ensuring the company's products comply with relevant regulations in the Indian market. This position reports to the Director-Regulatory Affairs and is based in Mumbai.KEY RESPONSIBILITIESDevelop and...


  • Mumbai, Maharashtra, India Kenvue Full time

    About the RoleWe are currently recruiting for an Associate Manager, Regulatory Affairs to join our team at Kenvue. This position reports to Director-Regulatory Affairs and is based at Mumbai.Key ResponsibilitiesAct as a strategic business partner to lead the Essential Health portfolio, Cosmetics (Exports), specific cosmetics brand, and self-care drug brands,...


  • 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 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 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...