Regulatory Affairs Manager

2 weeks ago

Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 14,40,000 - ₹ 21,60,000

Job Title: Regulatory Affairs Manager

About the Role

This is an exciting opportunity for a highly skilled Regulatory Affairs professional to join our organization and contribute to the success of our team. We are seeking an experienced Regulatory Affairs Executive to lead our regulatory strategy, manage regulatory submissions, and maintain strong relationships with regulatory agencies.

Key Responsibilities
  • Compile and submit marketing authorization applications for EU, UK, and AUS-NZ in eCTD format, ensuring compliance with regulatory requirements.
  • Manage variation applications for EU, UK, and AUS-NZ, maintaining accurate records and communicating effectively with stakeholders.
  • Review documents related to dossier compilation, query responses, and regulatory submissions, ensuring quality and accuracy.
  • Stay up-to-date with regulatory guidelines, requirements, and industry developments, providing expert advice to the team.
Required Skills and Qualifications
  • Proven experience with eCTD software, e-publishing requirements, and regulatory submissions throughout the project lifecycle.
  • Initial MAA submission and Variations experience for EU, with a strong understanding of regulatory requirements.
  • Excellent technical knowledge, review skills, and analytical attitude, with a focus on regulatory submissions.
  • Strong knowledge of CTD/eCTD requirements for modules 2 and 3, with the ability to apply this knowledge in a practical setting.
  • Compilation of module 1 and portal submissions experience, preferably with a track record of success.
  • Ability to think critically, try new approaches when faced with challenges, and communicate effectively with stakeholders.
  • Excellent written and oral communication skills, with a focus on building strong relationships with regulatory agencies and internal stakeholders.
Benefits

This role offers a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and experienced Regulatory Affairs professional looking for a new challenge, we encourage you to apply.

How to Apply

To be considered for this exciting opportunity, please submit your resume and cover letter outlining your relevant experience and qualifications. We thank all applicants for their interest; however, only those selected for an interview will be contacted.

  • Regulatory Affairs Manager

    7 days ago

    Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

    Regulatory Affairs Manager - Submission Publishing Job DescriptionJob Summary:We are seeking a highly skilled Regulatory Affairs Manager to lead our submission publishing efforts. As a key member of our team, you will be responsible for delivering high-quality submissions while ensuring compliance with global health authority requirements.Key...

  • Regulatory Affairs

    2 weeks ago

    Mumbai, Maharashtra, India CliniLaunch Research Institute Full time

    Job DescriptionPosition: Sr. Executive/Asst. Manager/Deputy Manager-Regulatory Affairs (Domestic).Location: Andheri, Mumbai.Qualification: M. Pharm. (Experienced preferred).JOB DESCRIPTION Regulatory Affairs (Domestic)The role will involve expertise in D & C Act and Rules as well as FSSAI regulations withexperience in FDA related activities. This profile...

  • Regulatory Affairs Specialist

    2 weeks ago

    Mumbai, Maharashtra, India beBeeRegulatoryAffairs Full time ₹ 15,00,000 - ₹ 30,00,000

    Job OverviewThe Manager of Regulatory Affairs will be a specialist professional with comprehensive knowledge in the area of regulatory affairs.Main Responsibilities:Develop and manage product registration submissions, progress reports, supplements, amendments, or periodic experience reports as a highly experienced and knowledgeable resource within the...

  • Regulatory Affairs

    2 weeks ago

    Mumbai, Maharashtra, India CliniLaunch Research Institute Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Position: Sr. Executive/Asst. Manager/Deputy Manager-Regulatory Affairs (Domestic).Location: Andheri, Mumbai.Qualification: M. Pharm. (Experienced preferred).JOB DESCRIPTION – Regulatory Affairs (Domestic)The role will involve expertise in D & C Act and Rules as well as FSSAI regulations withexperience in FDA related activities. This profile will ensure...

  • Regulatory Affairs

    2 weeks ago

    Mumbai, Maharashtra, India Win in Life Academy Full time ₹ 6,00,000 - ₹ 12,00,000 per year

    Position: Sr. Executive/Asst. Manager/Deputy Manager-Regulatory Affairs (Domestic).Location: Andheri, Mumbai.Qualification: M. Pharm. (Experienced preferred).Experience- 1-5 YearsJOB DESCRIPTION – Regulatory Affairs (Domestic)The role will involve expertise in D & C Act and Rules as well as FSSAI regulations withexperience in FDA related activities. This...

  • Required Regulatory Affairs

    1 week ago

    Mumbai, Maharashtra, India NOVO Medi Sciences Pvt ltd Full time ₹ 7,00,000 - ₹ 9,00,000 per year

    Required Regulatory Affairs | Chembur Salary: Job Title: Regulatory Affairs Location: Chembur Key Responsibilities: Regulatory Expertise: Manage the regulatory process for Pharmaceutical Finished Formulations across CIS, LATAM, and Africa. Dossier Management: Compile and review ACTD and CTD dossiers to ensure accuracy and compliance. MOH Query Response:...

  • Regulatory Affairs

    1 week ago

    Navi Mumbai, Maharashtra, India Peoplefy Full time

    &## ; We're Hiring: Regulatory Affairs – CMC Associate &## ; Location: Navi Mumbai &## ; Years of Experience:4+ years &## ; Work from Office &## ; Notice Period: Looking for immediate joiners Skills Required: &## ; Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences, or a related field. &## ; 4+ years of experience in Regulatory Affairs...

  • Regulatory Affairs Specialist

    2 weeks ago

    Mumbai, Maharashtra, India beBeeRegulatoryAffairs Full time ₹ 1,04,000 - ₹ 1,30,878

    Job Overview:">Lead Consultant - Regulatory Affairs Specialist. At our company, we are seeking an experienced and skilled professional to support our clients in regulatory affairs. The ideal candidate will have a strong background in chemistry, manufacturing, and controls (CMC) with excellent analytical and problem-solving skills.">The role involves...

  • Regulatory Affairs Leadership Role

    2 weeks ago

    Mumbai, Maharashtra, India beBeeRegulatoryAffairs Full time ₹ 1,04,000 - ₹ 1,30,878

    Senior Manager Regulatory Affairs Job DescriptionThe Senior Manager Regulatory Affairs will lead a team of professionals within the Regulatory Affairs Sub-Function.This role involves supervising professionals in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.The Team Leader...

  • Regulatory Affairs Expert

    1 week ago

    Mumbai, Maharashtra, India beBeeSpecialist Full time ₹ 15,24,000 - ₹ 2,01,12,000

    Job Description:We are seeking an experienced Regulatory Affairs Specialist to operate as an individual contributor under limited supervision. The role requires applying subject matter expertise in Regulatory Affairs to ensure compliance and successful product approvals. The ideal candidate will have the capacity to adapt their skills and knowledge to meet...