Regulatory Affairs Specialist

4 weeks ago

Delhi, India Apsida Life Science Full time

Regulatory Affairs Specialist - CMC Variations/Submissions

12 month contract - Immediate start

Overview: Join our Regulatory Affairs team and contribute to the management of Chemistry, Manufacturing, and Controls (CMC) You’ll be pivotal in ensuring compliance and efficiency in our regulatory processes.

Key Responsibilities:
CMC Change Control Assessment: Evaluate and assess regulatory implications of changes within CMC processes.
Submission Planning: Organize and strategize regulatory submissions, maintaining compliance with both timelines and regulations.
Submission Coordination: Oversee the writing, review, and approval process of CMC submissions, ensuring quality and accuracy.
Submission Dispatch: Ensure timely dispatch of all regulatory documents to appropriate bodies.
Health Authority Correspondence: Manage responses to queries from health authorities, coordinating input from Subject Matter Experts (SMEs).
Regulatory Triage: Receive and prioritize incoming CMC-related regulatory requests and inquiries.
Response Coordination: Manage the writing, review, and dispatch of responses to health authorities.
Ad Hoc Responsibilities: Manage procurement of necessary documents, maintain and update tracking tools like Veeva, and coordinate data remediation and submission planning.
Qualifications:
Bachelor’s or higher degree in a relevant scientific field.
Proven experience in Regulatory Affairs, with a strong focus on CMC.
Deep understanding of regulatory submission processes and guidelines.
Excellent organizational, communication, and project management skills.
Ability to work independently and collaboratively in a dynamic environment.

  • Regulatory Affairs Specialist

    2 weeks ago

    Delhi, India ProductLife Group Full time

    (JOINING ASAP) We are seeking for a Regulatory Affairs Specialist who will be responsible for ensuring the delivery of regulatory activities performed in the platform/hub:About usResponsibilitiesTo contribute to the production of client administrative documents and reports to be included in regulatory submissionsCompile, or supervise the compilation of...

  • Regulatory Affairs Specialist

    1 week ago

    Delhi, India ProductLife Group Full time

    (JOINING ASAP) We are seeking for a Regulatory Affairs Specialist who will be responsible for ensuring the delivery of regulatory activities performed in the platform/hub:About usResponsibilitiesTo contribute to the production of client administrative documents and reports to be included in regulatory submissionsCompile, or supervise the compilation of...

  • Regulatory Affairs Specialist

    2 weeks ago

    delhi, India ProductLife Group Full time

    (JOINING ASAP) We are seeking for a Regulatory Affairs Specialist who will be responsible for ensuring the delivery of regulatory activities performed in the platform/hub:About usResponsibilitiesTo contribute to the production of client administrative documents and reports to be included in regulatory submissionsCompile, or supervise the compilation of...

  • Regulatory Affairs Specialist

    1 week ago

    delhi, India ProductLife Group Full time

    (JOINING ASAP) We are seeking for a Regulatory Affairs Specialist who will be responsible for ensuring the delivery of regulatory activities performed in the platform/hub:About usResponsibilitiesTo contribute to the production of client administrative documents and reports to be included in regulatory submissionsCompile, or supervise the compilation of...

  • Regulatory Affairs Specialist

    1 month ago

    delhi, India Apsida Life Science Full time

    Regulatory Affairs Specialist - CMC Variations/Submissions12 month contract - Immediate startOverview: Join our Regulatory Affairs team and contribute to the management of Chemistry, Manufacturing, and Controls (CMC) You’ll be pivotal in ensuring compliance and efficiency in our regulatory processes.Key Responsibilities:CMC Change Control Assessment: ...

  • Regulatory Affairs Officer

    1 week ago

    Delhi, India NKG ADVISORY BUSINESS AND CONSULTING SERVICES PVT LTD Full time

    Regulatory Affairs Specialist - Legal Metrology and EPR India **Responsibilities**: Regulatory Compliance: Stay up-to-date with the latest Legal Metrology and EPR regulations in India. Ensure that all products and processes comply with these regulations. Documentation: Prepare and maintain all necessary documentation required for regulatory submissions,...

  • Regulatory Affairs Specialist

    3 weeks ago

    Delhi, India Meril Full time

    We are currently seeking a highly motivated and experienced professional in Regulatory Affairs specializing in Medical Devices Domain to join our team. Positions are: Executive / Sr. Executive / Asst. Manager Regulatory Affairs Experience: 3 to 9 years Location: Andheri east, Mumbai Working Days: 6 days (Mon-Sat) WFO Responsibilities: 1. Dossier collation...

  • Regulatory Affairs Specialist

    4 weeks ago

    delhi, India Meril Full time

    We are currently seeking a highly motivated and experienced professional in Regulatory Affairs specializing in Medical Devices Domain to join our team.Positions are: Executive / Sr. Executive / Asst. Manager - Regulatory AffairsExperience: 3 to 9 yearsLocation: Andheri east, MumbaiWorking Days: 6 days (Mon-Sat) - WFOResponsibilities:1. Dossier collation and...

  • Regulatory Affairs Specialist

    4 weeks ago

    Delhi, India Meril Full time

    We are currently seeking a highly motivated and experienced professional in Regulatory Affairs specializing in Medical Devices Domain to join our team.Positions are: Executive / Sr. Executive / Asst. Manager Regulatory AffairsExperience: 3 to 9 yearsLocation: Andheri east, MumbaiWorking Days: 6 days (Mon-Sat) WFOResponsibilities:1. Dossier collation and...

  • Regulatory Affairs Officer

    1 month ago

    Delhi, India NKG ADVISORY BUSINESS AND CONSULTING SERVICES PVT LTD Full time

    **Job Title: Cosmetics Regulatory Affairs Specialist - Delhi** Key Responsibilities: - Conduct regulatory assessments of cosmetic products to ensure compliance with relevant regulations and guidelines - Prepare and submit regulatory dossiers to the appropriate authorities for import registration of cosmetics under COS 02 and COS 04 categories - Stay...

  • Regulatory Affairs Specialist

    1 week ago

    Delhi, India Meril Full time

    We are currently seeking a highly motivated and experienced professional in Regulatory Affairs specializing in Medical Devices Domain to join our team.Positions are: Executive / Sr. Executive / Asst. Manager - Regulatory AffairsExperience: 3 to 9 yearsLocation: Andheri east, MumbaiWorking Days: 6 days (Mon-Sat) - WFOResponsibilities:1. Dossier collation and...

  • Regulatory Affairs Cdsco Executive

    2 months ago

    Delhi, Delhi, India Professional Utilities Full time

    We are currently seeking a proactive and dedicated Regulatory Affairs Specialist to join our team of business consultants. The primary responsibility of this role is to assist our clients in obtaining the necessary licenses and registrations from the Central Drugs Standard Control Organization (CDSCO) to establish and operate their pharmacy shops...

  • Regulatory Affairs Cdsco Executive

    1 month ago

    Delhi, Delhi, India Professional Utilities Full time

    We are currently seeking a proactive and dedicated Regulatory Affairs Specialist to join our team of business consultants. The primary responsibility of this role is to assist our clients in obtaining the necessary licenses and registrations from the Central Drugs Standard Control Organization (CDSCO) to establish and operate their pharmacy shops...

  • [23/05/2024] Regulatory Affairs Specialist

    3 weeks ago

    Delhi, India Apsida Life Science Full time

    Regulatory Affairs Specialist - CMC Variations/Submissions12 month contract - Immediate startOverview: Join our Regulatory Affairs team and contribute to the management of Chemistry, Manufacturing, and Controls (CMC) You’ll be pivotal in ensuring compliance and efficiency in our regulatory processes.Key Responsibilities:- CMC Change Control Assessment:...

  • Senior Regulatory Affairs Specialist

    2 months ago

    Delhi, India Meril Full time

    We are currently seeking a highly motivated and experienced professional in Regulatory Affairs specializing in Medical Devices to join our team. Job Titles: Executive / Senior Executive / Assistant Manager Regulatory AffairsExperience: 3 to 9 yearsLocation: Andheri east, MumbaiWorking Days: 6 days (Mon-Sat) WFOResponsibilities:1. Dossier collation and...

  • Regulatory Affairs Executive Cdsco

    2 months ago

    Nehru Place, Delhi, Delhi, India PU Professional Utilities Pvt. Ltd Full time

    We are currently seeking a proactive and dedicated Regulatory Affairs Specialist to join our team of business consultants. The primary responsibility of this role is to assist our clients in obtaining the necessary licenses and registrations from the Central Drugs Standard Control Organization (CDSCO) to establish and operate their pharmacy shops...

  • Regulatory Affairs Executive Cdsco

    3 days ago

    Nehru Place, Delhi, Delhi, India PU Professional Utilities Pvt. Ltd Full time

    We are currently seeking a proactive and dedicated Regulatory Affairs Specialist to join our team of business consultants. The primary responsibility of this role is to assist our clients in obtaining the necessary licenses and registrations from the Central Drugs Standard Control Organization (CDSCO) to establish and operate their pharmacy shops...

  • Regulatory Affairs Cdsco Executive

    1 week ago

    New Delhi, India Professional Utilities Full time

    We are currently seeking a proactive and dedicated Regulatory Affairs Specialist to join our team of business consultants. The primary responsibility of this role is to assist our clients in obtaining the necessary licenses and registrations from the Central Drugs Standard Control Organization (CDSCO) to establish and operate their pharmacy shops...

  • Regulatory Affairs

    2 weeks ago

    New Delhi, India People First Consultants Full time

    Job:Regulatory Affairs Specialist/SeniorSpecialist/Assistant Manager Experience:1012YearsSkills:The ideal candidate would have adiploma/degree in a scientific discipline such asBiology Microbiology Pharmacy pharmacology Biotechnologyengineering or medical technology. • Minimum 5years of experience in Medical devices regulatory affairs and 78years of...

  • Regulatory Affairs

    2 weeks ago

    new delhi, India People First Consultants Full time

    Job:Regulatory Affairs Specialist/SeniorSpecialist/Assistant Manager Experience:1012Years Skills: The ideal candidate would have adiploma/degree in a scientific discipline such asBiologyMicrobiology Pharmacy pharmacology Biotechnologyengineering or medical technology.• Minimum 5years of experience in Medical devices regulatory affairs and 78years of...