Senior Regulatory Submissions Manager

2 days ago

Navi Mumbai, Maharashtra, India G&L Scientific Full time ₹ 12,00,000 - ₹ 36,00,000 per year

Contract: Permanent Full-Time

Closing Date: 05/12/25

We are seeking two Senior Regulatory Submissions Managers to play a pivotal role in shaping how regulatory submissions are managed within our new Veeva RIMS platform.

This is a high-impact opportunity to influence process design, system configuration, and regulatory compliance across a global organization.

The Role

Key Responsibilities:

Define Submission Management Processes -

  • Lead the design and documentation of end-to-end Regulatory Submission Management workflows
  • Partner across RA, QA, Clinical, and IT to identify process gaps and drive operational excellence

Translate Business Needs into Veeva Configuration -

  • Convert business requirements into Veeva RIMS configuration specifications
  • Collaborate with IT and Veeva consultants to ensure the system supports planning, tracking, publishing, and archival of submissions

Ensure Compliance & Best Practice Alignment -

  • Align processes with Health Authority expectations and industry standards
  • Maintain robust documentation of decisions, processes, and configurations

Serve as SME & Project Contributor -

  • Act as Subject Matter Expert in workshops, design sessions, testing cycles, and UAT
  • Help guide change management and end-user adoption
Requirements

Required Skills & Experience:

  • Experience in Regulatory Affairs and Submissions Management
  • Hands-on familiarity with Veeva RIMS (or comparable regulatory systems)
  • Strong communicator, collaborator, and process-thinker
  • Comfortable influencing cross-functional teams in a global environment

Why Join Us?

This role offers the opportunity to work at the forefront of global drug development while embedded with a top-tier pharmaceutical client. You will gain exposure to high-impact projects, contribute to advancing innovative therapies, and play a strategic role in shaping regulatory pathways worldwide - all while being supported by our expert, global teams of consultants.

If you're passionate about regulatory excellence and digital transformation in life sciences, we'd love to hear from you.

How to Apply

If you would be interested in joining the team at G&L Scientific, please send your CV to [email protected] today.

G&L Scientific is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status or race.

We recruit based on talent alone and firmly believe that an individual's background should play no part in the recruitment and selection process.

  • Compliance Manager-Regulatory Relationship

    17 hours ago

    Mumbai, Maharashtra, India b-3044-47a7-a621-0e0120a896a4 Full time ₹ 12,00,000 - ₹ 25,00,000 per year

    Job RequirementsRole/ Job Title:Compliance Manager-Regulatory RelationshipFunction/ Department:Regulatory ComplianceJob PurposeThe role entails the responsibility to support Senior Compliance Manager in ensuring bank's submissions, to ensure policies and procedures comply with regulatory and ethical standards. It includes evaluating all current and new...

  • ICSR Submission Specialist

    2 days ago

    Mumbai, Maharashtra, India Alkem Laboratories Ltd. Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    About AlkemAlkem Laboratories Limited is an Indian multinational pharmaceutical company headquartered in Mumbai, that manufactures and sells pharmaceutical generics, formulations and nutraceuticals in India and globally over 50 countries. We have consistently been ranked amongst the top five pharmaceutical companies in India. Our portfolio includes...

  • Manager Regulatory Affairs

    6 days ago

    Navi Mumbai, Maharashtra, India Bharat Serums and Vaccines Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    Role & responsibilitiesPreparation and reviewing of CTD and ACTD dossier.Co-ordination with Plant and R&D to collect inputs required for Regulatory Submission.Co-ordination with plant for Regulatory compliances.Timely achievement of monthly plan & timely query response.Gap Analysis/Updation of Master data.Review of Change Controls, Stability Protocol,...

  • Manager / Sr Manager Regulatory Affairs– US Markets

    6 days ago

    Navi Mumbai, Maharashtra, India Umedica Laboratories Private Limited Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    UMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA.UMEDICA was...

  • Regulatory Manager

    1 week ago

    Mumbai, Maharashtra, India Quality HR Services Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Responsibilities.Global Product Registration & Dossier ManagementLead the full registration lifecycle (pre-market research, submission, renewal) for all target export countries.Compile regulatory dossiers, including 5-batch analysis and efficacy data, ensuring strict adherence to national formats.Serve as the primary Point of Contact (POC) to coordinate data...

  • Asst Manager/ Manager- Regulatory Affairs

    16 hours ago

    Navi Mumbai, Maharashtra, India Bharat Serums and Vaccines Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Role & responsibilitiesPreparation and reviewing of CTD and ACTD dossier.Co-ordination with Plant and R&D to collect inputs required for Regulatory Submission.Co-ordination with plant for Regulatory compliances.Timely achievement of monthly plan & timely query response.Gap Analysis/Updation of Master data.Review of Change Controls, Stability Protocol,...

  • Regulatory Operations Expert

    4 days ago

    Navi Mumbai, Maharashtra, India Fortrea Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Job Overview:Perform various project management and regulatory affairs activities for Fortrea clients.Manage team including performance reviews, human resource issues, and assist Senior Management in assigning resources to projects as required.Manage, coordinate and oversee the overall Regulatory Operations associated with...

  • Senior Manager Regulatory Affairs

    1 week ago

    Mumbai, Maharashtra, India Abreast Global Consulting Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Role DescriptionThis is a full-time on-site role for a Senior Manager of Regulatory Affairs based in Mumbai.Check for compliance on formulation as per FSSAI / Export/ International RegulationsLabelling in accordance with FSSAI regulations /Export/ International Regulations for products.Scrutinize and approve all labels/Artwork for conformance with all the...

  • Vice President Regulatory Affairs

    7 days ago

    Mumbai, Maharashtra, India Utkarsh Placement Pvt. Ltd. Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    One of our esteemed Pharma client based at Mumbai is looking for AVP/VP Regulatory Affairs for US Markets. Job Description is given below;Job Description – Vice President (VP) Regulatory AffairsIndustry:Pharmaceutical ManufacturingLocation: MumbaiExperience:20+ yearsQualification:BPharm/M.Pharm / Ph.D. in Pharmaceutical SciencesRole OverviewWe are seeking...

  • Regulatory Affairs Trainee

    6 days ago

    Navi Mumbai, Maharashtra, India Shalina Healthcare Full time ₹ 4,00,000 - ₹ 8,00,000 per year

    Job Purpose:To assist the Regulatory Affairs team in day-to-day activities related to CDSCO, ONDL and State FDA submissions, documentation, and compliance.Key Responsibilities:Submissions & CoordinationPreparation and submission of applications to CDSCO, ONDL and State FDA for:Export NOC Application of Banned & Unapproved productsProduct Permission...