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

High Salary : Regulatory Affairs Executive

Biotech HealthcareIndia
2 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 :

    LinkedIn :

    Instagram :

    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

    High Salary Executive • India

    Related jobs
    • Promoted
    ▷ (High Salary) Regulatory Affairs Associate

    ▷ (High Salary) Regulatory Affairs Associate

    PeoplefyNagpur, Maharashtra, India
    Hi Everyone, I am on lookout for Regulatory Affairs Associate for US based, diversified pharmaceutical company in Navi Mumbai. Please refer below JD and share your profile on pallavi.Experienced in...Show moreLast updated: 21 days ago
    • Promoted
    • New!
    ▷ Apply Now : Regulatory Affairs Associate I

    ▷ Apply Now : Regulatory Affairs Associate I

    Teva PharmaceuticalsIndia
    Role : Regulatory Affairs Associate I (Regulatory Operation- Regulatory Data Analytics).The role of GRO Regulatory Data Analytics is to : . Manage Teva's data in accordance with requirements for xEVPMD...Show moreLast updated: 5 hours ago
    • Promoted
    • New!
    (Apply in 3 Minutes) Regulatory Affairs Associate I

    (Apply in 3 Minutes) Regulatory Affairs Associate I

    Teva PharmaceuticalsIndia
    Role : Regulatory Affairs Associate I (Regulatory Operation- Regulatory Data Analytics).The role of GRO Regulatory Data Analytics is to : . Manage Teva's data in accordance with requirements for xEVPMD...Show moreLast updated: 1 hour ago
    • Promoted
    Manager Global Regulatory Affairs

    Manager Global Regulatory Affairs

    Biocon BiologicsIndia
    Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products including technical and Regulatory aspects.Responsib...Show moreLast updated: 21 days ago
    • Promoted
    Regulatory Reporting

    Regulatory Reporting

    YES BANKIndia
    Should be well conversant with IRAC, Exposure, Large exposure norms, Resolution Plan Implementation, Sensitive sector monitoring, etc. Exposure in preparation of DSB, CRILC, PSL, MSME, SLBC, Default...Show moreLast updated: 30+ days ago
    • Promoted
    • New!
    Regulatory Affairs Associate II [3 Days Left]

    Regulatory Affairs Associate II [3 Days Left]

    Teva PharmaceuticalsIndia
    Role : Regulatory Affairs Associate II.Work location : Mumbai & Bangalore.The Associate II, Complex Gx, Regulatory Affairs is responsible for the preparation and submission of high-quality regulatory...Show moreLast updated: 1 hour ago
    • Promoted
    Regulatory Affairs Lead, Project Manager

    Regulatory Affairs Lead, Project Manager

    ArtiXioIndia
    We are looking for a Regulatory Affairs Lead / Project Manager.The ideal candidate is a passionate regulatory professional with hands-on experience in preparing and submitting applications to Health...Show moreLast updated: 21 days ago
    • Promoted
    AR Executive

    AR Executive

    MedyMatic Business Solutions PVT. LTDNagpur, Maharashtra, India
    At MedyMatic Business Solutions, we specialize in providing comprehensive revenue cycle management (RCM) and medical billing services tailored to meet the unique needs of healthcare providers.We be...Show moreLast updated: 20 days ago
    • Promoted
    Regulatory Affairs Associate II

    Regulatory Affairs Associate II

    Teva PharmaceuticalsIndia
    Role : Regulatory Affairs Associate II.Work location : Mumbai & Bangalore.The Associate II, Complex Gx, Regulatory Affairs is responsible for the preparation and submission of high-quality regulatory...Show moreLast updated: 30+ days ago
    • Promoted
    Regulatory Affairs Associate I

    Regulatory Affairs Associate I

    Teva PharmaceuticalsNagpur, IN
    Regulatory Affairs Associate I (Regulatory Operation- Regulatory Data Analytics).The role of GRO Regulatory Data Analytics is to : . Manage Teva’s data in accordance with requirements for xEVPMD in or...Show moreLast updated: 2 days ago
    • Promoted
    • New!
    Regulatory Compliance Specialist

    Regulatory Compliance Specialist

    Jupiter AI LabsNagpur, Maharashtra, India
    We are seeking a Regulatory & Compliance Specialist on a contract basis to support our compliance requirements in India and international destination countries. This role is ideal for professionals ...Show moreLast updated: 7 hours ago
    • Promoted
    • New!
    Regulatory Affairs Specialist

    Regulatory Affairs Specialist

    UpMan PlacementsNagpur, IN
    Regulatory Submissions and compliance.Prepare and submit various applications such as additional product permission, Layout approval, facility modification approval, technical person approval, Test...Show moreLast updated: 8 hours ago
    • Promoted
    Regulatory Compliance Specialist -2+

    Regulatory Compliance Specialist -2+

    Jupiter AI LabsNagpur, IN
    Regulatory & Compliance Specialist.India and international destination countries.This role is ideal for professionals experienced in handling regulatory filings, certifications, and export-related ...Show moreLast updated: 17 days ago
    • Promoted
    • New!
    ▷ Apply Now : Senior Manager Regulatory Affairs

    ▷ Apply Now : Senior Manager Regulatory Affairs

    SOLARIAN ASTRA PVT LTDIndia
    Job Title : Senior Manager – Regulatory Affairs.Location : Noida, India | Hybrid.EPC, commissioning, regulatory approvals, charging, and maintenance. We deliver integrated, end-to-end solutions for so...Show moreLast updated: 1 hour ago
    • Promoted
    Assistant Manager Regulatory Affairs

    Assistant Manager Regulatory Affairs

    Forest EssentialsIndia
    JOB TITLE- ASSISTANT MANAGER (REGULATORY AFFAIRS).DEPARTMENT- REGULATORY AFFAIRS.INDUSTRY- PERSONAL CARE - COSMETICS / AYURVEDIC. ROLE- TECHNICAL REGULATORY AFFAIRS.Review Product formulation as per...Show moreLast updated: 16 days ago
    • Promoted
    • New!
    ▷ Urgent : Regulatory Affairs Associate I

    ▷ Urgent : Regulatory Affairs Associate I

    Teva PharmaceuticalsIndia
    Role : Regulatory Affairs Associate I (Regulatory Operation- Regulatory Data Analytics).The role of GRO Regulatory Data Analytics is to : . Manage Teva's data in accordance with requirements for xEVPMD...Show moreLast updated: 1 hour ago
    • Promoted
    Executive

    Executive

    Rubicon Research LimitedIndia
    Responsible for formulation and process development of Oncology and hormonal products of oral dosage forms (Oral solid and Oral liquid formulations). Troubleshooting and problem-solving of unresolve...Show moreLast updated: 1 day ago
    • Promoted
    Regulatory Affairs Officer

    Regulatory Affairs Officer

    A.P. Moller - MaerskIndia
    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: 21 days ago
    • Promoted
    Regulatory Affairs Associate

    Regulatory Affairs Associate

    PeoplefyIndia
    I am on lookout for Regulatory Affairs Associate for US based, diversified pharmaceutical company in Navi Mumbai.Please refer below JD and share your profile on pallavi. Experienced in preparing, re...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Manager Regulatory Affairs

    Senior Manager Regulatory Affairs

    SOLARIAN ASTRA PVT LTDIndia
    Job Title : Senior Manager – Regulatory Affairs Company : Solarian Astra Pvt.Location : Noida, India | Hybrid.About Solarian Astra Solarian Astra Pvt. EPC, commissioning, regulatory approvals, charging...Show moreLast updated: 1 day ago