Regulatory Affairs Career Opportunity

21 hours ago

Tiruchi, Tamil Nadu, India beBeeRegulatoryAffairs Full time ₹ 15,00,000 - ₹ 20,00,000

Job Title: Regulatory Affairs Professional

This is a role that requires regulatory affairs expertise to ensure compliance with international guidelines and country-specific requirements. The successful candidate will be responsible for coordinating with internal teams and external stakeholders to support product registrations, timely dossier submissions, query responses, and compliance with regulatory standards.

The ideal candidate should have a strong understanding of global regulatory guidelines and dossier preparation. Additionally, they should possess excellent organizational and analytical skills, as well as proficiency in MS Office and document management systems.

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., 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.

Required Skills and Qualifications:

  • 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.

Benefits:

  • A dynamic and challenging work environment.
  • Ongoing training and development opportunities.
  • The chance to work with a talented team of professionals.

Other Information:

  • This is an individual contributor role, reporting to the Assistant Manager - RA.

Functional Keywords: Regulatory Affairs Expertise

  • Regulatory Affairs Expert

    2 weeks ago

    Tiruchi, Tamil Nadu, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 20,00,000

    Regulatory Affairs ProfessionalThe ideal candidate will possess a strong background in regulatory affairs, with a focus on chemical, manufacturing, and controls (CMC) aspects.Key Responsibilities:Oversee the compilation and submission of annual reports, amendments, and deficiency responses to ensure compliance with regulatory requirements.Interface with...

  • Compliance and Regulatory Affairs Expert

    2 days ago

    Tiruchi, Tamil Nadu, India beBeeRegulatoryAffairs Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

    Job OverviewWe are seeking an experienced Compliance and Regulatory Affairs Expert to join our team. The ideal candidate will have a strong background in regulatory compliance, excellent communication skills, and the ability to navigate complex regulations.Key Responsibilities

  • Senior Medical Device Regulatory Affairs Specialist

    1 week ago

    Tiruchi, Tamil Nadu, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

    Regulatory Affairs ExecutiveWe are seeking an experienced Regulatory Affairs Executive to join our team in the Medical Device Industry. This role involves supporting clients in ensuring compliance with regulatory frameworks and quality systems.

  • Food Regulatory Affairs Leader

    18 hours ago

    Tiruchi, Tamil Nadu, India beBeeRegulatory Full time ₹ 12,00,000 - ₹ 20,00,000

    Job Description:Our ideal candidate will lead a team in the Food Regulatory Affairs department, drive policy initiatives, engage with government departments, and generate revenue through impactful programs.This is a high-profile position that requires a strong understanding of Indian food regulations, policy, advocacy, trade, etc. The successful candidate...

  • Chief Corporate Affairs Officer

    4 days ago

    Tiruchi, Tamil Nadu, India beBeeInfluencer Full time ₹ 2,00,00,000 - ₹ 2,51,00,000

    Corporate Affairs Leadership RoleThis is a key leadership position that oversees corporate affairs, ensuring alignment with the organization's objectives.Key Responsibilities:Forge strategic partnerships with government officials to advance business interests.Maintain compliance with regulatory requirements, including environmental clearances and labor...

  • Senior Medical Device Regulatory Specialist

    1 week ago

    Tiruchi, Tamil Nadu, India beBeeRegulatoryAffairs Full time ₹ 80,00,000 - ₹ 1,50,00,000

    Job Overview:We are seeking an experienced Regulatory Affairs professional to join our organization.The ideal candidate will have a strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration to support product development, registration, and commercialization.Main Responsibilities:We are looking for a skilled...

  • Senior Food Regulatory Specialist

    6 days ago

    Tiruchi, Tamil Nadu, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

    Job OpportunityWe are seeking a highly skilled Senior Regulatory Expert to join our team.The ideal candidate will have in-depth knowledge of international food regulations and the ability to lead regulatory intelligence on domestic and export food labelling regulations across multiple markets.Main Responsibilities:Analyse and interpret global regulatory...

  • Chief Regulatory Analyst

    7 days ago

    Tiruchi, Tamil Nadu, India beBeeRegulatory Full time ₹ 72,00,000 - ₹ 1,20,00,000

    Data Solutions Coordinator Role Overview\helpers to a Data Solutions Coordinator role involve monitoring and analyzing the global regulatory landscape within the life sciences industry. Key responsibilities include supporting regulatory intelligence products and services by participating in global surveillance and data acquisition activities, as well as...

  • Career Opportunities in Auditing and Taxation

    18 hours ago

    Tiruchi, Tamil Nadu, India beBeeTaxation Full time ₹ 10,000 - ₹ 12,000

    Job DetailsWe are seeking highly motivated and skilled professionals to join our team at Asire Consulting LLP. This is an excellent opportunity for individuals pursuing a career in auditing and taxation.The ideal candidate will have strong research skills, excellent communication and presentation skills, and a willingness to learn complex aspects of the...

  • Career Opportunities in IT

    1 week ago

    Tiruchi, Tamil Nadu, India beBeeIT Full time ₹ 8,00,000 - ₹ 12,00,000

    Unlock Your IT Career PotentialWe are on a mission to equip students, freshers, and working professionals with the latest industry-focused IT skills. Our comprehensive training programs feature hands-on learning, live projects, and placement support.