Talent.com
This job offer is not available in your country.
Regulatory Affairs Executive

Regulatory Affairs Executive

Biotech HealthcareAhmedabad, Gujarat, India
15 days ago
Job description

Role Objective

Key objective of this role is to prepare, review, and maintain regulatory documents to ensure compliance with international guidelines and country-specific requirements. The role involves coordination with internal teams and external stakeholders to support product registrations, timely dossier submissions, query responses, and compliance with regulatory standards.

Desired Candidate Profile

  • Graduate / Postgraduate in Pharmacy, Life Sciences, Biotechnology, or a related discipline.
  • 3–6 years of relevant experience in regulatory affairs, preferably in pharmaceuticals, biotechnology, or healthcare.
  • Strong understanding of global regulatory guidelines and dossier preparation.
  • Detail-oriented, with excellent organizational and analytical skills.
  • Proficiency in MS Office (Word, Excel, PowerPoint) and document management systems.
  • Good written and verbal communication skills.

Roles & Responsibilities

  • Screen and analyze documents received for product registration requests as per country-specific guidelines.
  • Prepare, compile, and review product dossiers in compliance with customer and regulatory requirements.
  • Prioritize dossiers to meet defined timelines and ensure timely submission to the regulatory authorities.
  • Draft and coordinate responses to regulatory queries with appropriate documentation and justifications.
  • Arrange supportive batch-related documents (e.g., DOC, COA) for registration samples.
  • Manage legalization or apostillation of registration documents, including coordination with agencies, tracking timelines, and processing payments / invoices.
  • Support the Compliance team by providing updated documents required for technical file preparation.
  • Periodically review and update Technical Master Files to ensure consistency across product categories.
  • Coordinate with cross-functional teams (Quality, Production, R&D, and Compliance) to fulfill regulatory requirements and address audit queries.
  • Ensure timely preparation and submission of documents related to audit findings.
  • Adhere to departmental priorities and provide support for additional tasks as assigned.
  • Functional Skills Required

  • Knowledge of international regulatory requirements and guidelines.
  • Expertise in dossier compilation, review, and submission processes.
  • Ability to prepare and analyze technical and compliance-related documentation.
  • Familiarity with audit documentation and regulatory query management.
  • Document management and record-keeping skills.
  • Behavioral Skills Required

  • Strong attention to detail and accuracy.
  • Ability to work effectively under pressure and meet strict deadlines.
  • Team player with strong collaboration and coordination skills.
  • Proactive, adaptable, and willing to take initiative.
  • Professional communication and interpersonal skills.
  • Team Size to be Handled :

    Individual contributor role, reporting to the Assistant Manager - RA.

    Important Links : Website :

    Instagram : Biotech Vision Care

    Biotech is an Equal Opportunity Organization promoting diversity while ensuring no discrimination on any ground, including gender, race, religion, age, sexual orientation, disability, etc.

    Create a job alert for this search

    Executive Regulatory • Ahmedabad, Gujarat, India

    Related jobs
    • Promoted
    Regulatory Affairs Specialist

    Regulatory Affairs Specialist

    Frisch Medical Devices PVT LTDAhmedabad, Gujarat, India
    Job Title : Regulatory Affairs Junior Manager.At Ahmedabad Office , Near Thaltej Crossroads.RA Head and Regulatory Department at HO / Director. Office hours : 9,30 AM to 6 PM.Week of : Sunday and Satu...Show moreLast updated: 30+ days ago
    • Promoted
    • New!
    ▷ Only 24h Left : Regulatory Affairs Manager

    ▷ Only 24h Left : Regulatory Affairs Manager

    Red Envelope ConsultantsAhmedabad, Gujarat, India
    Job Title : Senior Regulatory Manager – RoW Market Department : Regulatory Affairs Job Summary : The Senior Regulatory Manager will be responsible for the preparation, review, and submission of hig...Show moreLast updated: 1 hour ago
    • Promoted
    Regulatory Affairs Executive

    Regulatory Affairs Executive

    Cadila Pharmaceuticals LimitedDholka, Gujarat, India
    Cadila Pharmaceuticals Ltd, is one of the Largest Privately- held Pharmaceuticals companies in India.Over the past seven decades, We have been developing and manufacturing affordable medicines for ...Show moreLast updated: 26 days ago
    • Promoted
    Executive - Regulatory Affairs

    Executive - Regulatory Affairs

    ConfidentialAhmedabad
    Preparation of Financial Models for Tariff Petitions.Drafting of Tariff Petitions, Replying to queries of GERC / JERC / CERC related to Tariff Petitions. Analysis of Miscellaneous Petitions / Orders of di...Show moreLast updated: 3 days ago
    • Promoted
    Sr. Legal & Contracts Executive

    Sr. Legal & Contracts Executive

    Aerocraft EngineeringAhmedabad, Gujarat, India
    Aerocraft Engineering India Pvt.Ahmedabad, provides services to US based Architecture, Engineering and Construction group of companies : . Russell and Dawson – An Architecture / Engineering / Planning fir...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Regulatory Affairs Executive

    Senior Regulatory Affairs Executive

    White Force GroupAhmedabad, Gujarat, India
    Dossier Preparation & Compilation : Lead and oversee the preparation, review, and submission of.CTD, ACTD, and eCTD formats for global markets, ensuring compliance with. Regulatory Strategy & Market ...Show moreLast updated: 3 days ago
    • Promoted
    R & D Executive

    R & D Executive

    ConfidentialGandhinagar
    Plan, setup, monitor, and work up chemical reactions independently.Monitor progress of reactions using standard analytical techniques (TLC, GC, HPLC, LCMS, etc. Isolate products and optimize reactio...Show moreLast updated: 8 days ago
    • Promoted
    • New!
    Apply Now : Regulatory Affairs Specialist

    Apply Now : Regulatory Affairs Specialist

    Frisch Medical Devices PVT LTDAhmedabad, Gujarat, India
    Job Title : Regulatory Affairs Junior Manager Location : At Ahmedabad Office , Near Thaltej Crossroads Department : RA Reports To : RA Head and Regulatory Department at HO / Director Employment Type...Show moreLast updated: 1 hour ago
    • Promoted
    Technical Recruitment Executive (Remote- India)

    Technical Recruitment Executive (Remote- India)

    hotsourcedGandhinagar, IN
    Remote
    Hotsourced’s vision is to democratise access to the world’s talent pool.Connecting great employers with great employees across geographic and regulatory boundaries. Our headhunter and employer-of-re...Show moreLast updated: 17 days ago
    • Promoted
    Regulatory Affairs Officer

    Regulatory Affairs Officer

    A.P. Moller - MaerskGandhinagar, Gujarat, India
    Moller - Maersk is an integrated container logistics company working to connect and simplify its customers’ supply chains. As the global leader in shipping services, the company operates in 130 coun...Show moreLast updated: 3 days ago
    • Promoted
    Regulatory Affairs Manager

    Regulatory Affairs Manager

    Red Envelope ConsultantsAhmedabad, Gujarat, India
    Job Title : Senior Regulatory Manager – RoW Market.The Senior Regulatory Manager will be responsible for the preparation, review, and submission of high-quality regulatory dossiers and documents for...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Manager Regulatory Affairs

    Senior Manager Regulatory Affairs

    Cadila Pharmaceuticals LimitedDholka, Gujarat, India
    Senior Manager Regulatory Affairs.Handling submissions in Sugam & NSWS Portal.Preparation & Submission of o New Drug applications, Subsequent New Drug Applications. Clinical trial application - Phas...Show moreLast updated: 19 days ago
    • Promoted
    Regulatory Affairs Executive

    Regulatory Affairs Executive

    ConfidentialAhmedabad, India
    Key objective of this role is to prepare, review, and maintain regulatory documents to ensure compliance with international guidelines and country-specific requirements. The role involves coordinati...Show moreLast updated: 8 days ago
    • Promoted
    Regulatory Affairs

    Regulatory Affairs

    ConfidentialAhmedabad
    Total of 10 to 15 years in Regulatory Affairs (RA).At least 6 years of experience in regulated markets such as the USA, EU, UK, or CA. Multiple market experience is an advantage.Excellent written an...Show moreLast updated: 8 days ago
    • Promoted
    BLA Regulatory Publishing Specialist – Veeva eCTD

    BLA Regulatory Publishing Specialist – Veeva eCTD

    vueverse.Gandhinagar, IN
    BLA (Biologics License Application).Compile, format, and publish regulatory documents according to global health authority requirements. Ensure compliance with regulatory guidelines (FDA, EMA) and i...Show moreLast updated: 20 days ago
    • Promoted
    Head of AI Powered SaaS Product / Regulatory SME

    Head of AI Powered SaaS Product / Regulatory SME

    ComplyLensAnand, IN
    Hybrid (India-based with remote work flexibility).Please only apply if you have experience of working in Capital Markets and with financial regulations. Are you a dynamic, action-oriented individual...Show moreLast updated: 5 days ago
    • Promoted
    QHSE / TRAINING Executive

    QHSE / TRAINING Executive

    PANORAMA TECHNOLOGIESAnand, IN
    Updating and Controlling quality manual of company, procedures, policies, Roles & responsibilities for all profiles.Independent quality checks on operations / services. Collecting customer feedbacks d...Show moreLast updated: 7 days ago
    • Promoted
    Executive

    Executive

    Cadila Pharmaceuticals LimitedDholka, Gujarat, India
    Pre-Clinical Pathology Lab Executive.Dholka (Near Ahmedabad), Gujarat.Core responsibility related to GLP : .Planning and execution of blood collection from various laboratory animals.Monitoring anest...Show moreLast updated: 17 days ago