Senior Regulatory Affairs Professional

3 days ago

Jaipur, Rajasthan, India beBeeRegulatory Full time ₹ 10,00,000 - ₹ 20,00,000

Job Title:

Regulatory Affairs Specialist

The main goal of this role is to prepare, review and maintain regulatory documents to ensure compliance with international guidelines and country-specific requirements.

This involves coordination with internal teams and external stakeholders to support product registrations, timely dossier submissions, query responses and compliance with regulatory standards.

Key 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. 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.

Requirements:

  • Graduate or postgraduate degree 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.

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.

Working Environment:

As an individual contributor, you will report directly to the Assistant Manager - RA.

  • Regulatory Affairs Specialist

    5 days ago

    Jaipur, Rajasthan, India beBeeRegulatoryAffairs Full time ₹ 10,00,000 - ₹ 15,00,000

    Job Opportunity:Regulatory Affairs SpecialistWe are seeking a skilled Regulatory Affairs Specialist to support the preparation and submission of regulatory documents for global markets. The ideal candidate will have experience with Lifecycle Management (LCM), Veeva Vault RIM, and complex Initial and Variation submissions.Key Responsibilities:Prepare...

  • CMC Regulatory Affairs Specialist

    2 weeks ago

    Jaipur, Rajasthan, India beBeeRegulatoryAffairs Full time ₹ 1,20,00,000 - ₹ 2,00,00,000

    Regulatory Affairs Specialist Job Description:This position is responsible for leading and managing CMC regulatory activities, including preparing, reviewing, and filing USFDA submissions.The specialist will oversee the compilation and submission of Annual Reports, amendments, and deficiency responses.They will interface with cross-functional teams to gather...

  • Senior Director of Regulatory Affairs

    3 days ago

    Jaipur, Rajasthan, India beBeeFood Full time ₹ 75,00,000 - ₹ 1,50,00,000

    Regulatory Affairs LeadWe are seeking a highly skilled and motivated individual to lead and manage activities in the Food Regulatory Affairs, focusing on driving policy initiatives, liaising with government departments, engaging with industry stakeholders, generating revenue, and organizing impactful initiatives.Key Responsibilities:Analyze food regulations,...

  • Public Policy and Regulatory Affairs Expert

    7 days ago

    Jaipur, Rajasthan, India beBeePolicyexpert Full time ₹ 20,00,000 - ₹ 25,00,000

    About the RoleWe are seeking a highly skilled Public Policy and Regulatory Affairs Expert to join our team. As a key member of our organization, you will play a critical role in navigating the regulatory environment and ensuring alignment with our business goals. Job DescriptionThe ideal candidate will have 5+ years of experience in public policy and...

  • Regulatory Affairs Specialist

    7 days ago

    Jaipur, Rajasthan, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 20,00,000

    Job SummaryWe are seeking a detail-oriented Regulatory Affairs Associate to support end-to-end submissions for global markets. The selected candidate will have exposure to Lifecycle Management (LCM), Veeva Vault RIM, and complex Initial and Variation submissions.About the Role:Prepare Variation documents and/or evaluate post-approval CMC changes in...

  • Regulatory Affairs Specialist

    4 days ago

    Jaipur, Rajasthan, India beBeeCompliance Full time ₹ 80,00,000 - ₹ 1,40,00,000

    Job DescriptionAs a seasoned Compliance Manager, you will be responsible for ensuring the organization's adherence to regulatory requirements and industry best practices. Your role will involve monitoring ongoing compliance activities, preparing and submitting required reports and filings, and liaising with regulators and external parties.Key...

  • Head of Regulatory Affairs

    1 week ago

    Jaipur, Rajasthan, India beBeeCompliance Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

    Job Title: Compliance OfficerMandatory qualified Company Secretary (CS) with a strong advantage in Chartered Accountant (CA) qualification.We are seeking an experienced and highly skilled professional to oversee all compliance functions, focusing on corporate governance, risk management, and statutory filings. Key responsibilities include advising the board...

  • Senior Regulatory Compliance Professional

    6 days ago

    Jaipur, Rajasthan, India beBeeCompliance Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

    Job OpportunityWe are seeking a detail-oriented and proactive compliance professional to join our organization. The successful candidate will play a critical role in ensuring that our trading activities and internal practices comply with regulatory standards and internal policies.Key Responsibilities:Conduct thorough reviews of employee trading activities,...

  • Chief Regulatory Compliance Officer

    2 weeks ago

    Jaipur, Rajasthan, India beBeeCompliance Full time ₹ 20,00,000 - ₹ 28,00,000

    Regulatory Compliance ProfessionalThis is a highly specialized role ensuring the organization adheres to all regulatory requirements.Key Responsibilities:Monitoring and implementing regulatory updates relevant to the organization.We are looking for an experienced professional with expertise in risk management, legal matters, and regulatory...

  • Manager, Regulatory Reporting

    1 week ago

    Jaipur, Rajasthan, India SK Finance Ltd Full time ₹ 15,00,000 - ₹ 20,00,000 per year

    Company DescriptionSK Finance Ltd. is a prominent Middle Layer NBFC specializing in vehicle loans, small business loans, and personal loans, primarily serving rural and semi-urban areas in North, West, and Central India. With over 570 branches across 12 states and Union territories, and a dedicated team of more than 11,000 employees, SK Finance Ltd. is...