Sr. Executive- Regulatory Affairs

2 weeks ago

Navi Mumbai, Maharashtra, India Titan Laboratories Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Role & responsibilities

Dossier Preparation and Submission:

  • Compile and review regulatory submissions in ACTD, CTD and formats.
  • Ensure all regulatory documents are accurate, complete, and compliant with regulatory requirements.
  • Review of Plant and R&D Data:
  • Review R&D data to confirm compliance with regulatory expectations and assist in developing effective submission strategies.
  • Regulatory Compliance and Updates:
  • Stay informed of changes in Asian or Regulated market regulations, ensuring timely implementation of updates to maintain compliance.
  • Provide regulatory insights to internal teams on best practices for data management and documentation.
  • Documentation and Record Keeping:
  • Maintain well-organized records of submissions, communications, and approvals.
  • Use regulatory software and systems for document tracking, version control, and report generation.

Markets - Regulated (EU/UK/Aus) or ROW (Asia & Africa)

Desirable Skills & Competencies:

  • Attention to Detail: Ability to review and analyze technical documentation with precision.
  • Collaboration: Effective communication skills for working with R&D, manufacturing, and quality assurance teams.
  • Problem Solving: Proactive in identifying compliance issues and developing solutions to address regulatory challenges.
  • Proficient in MS Office and regulatory documentation software.

Interested candidates can apply or mail your resume on or -contact Ext 725).

If you have good references you can share on above details.

Thanks & Regards,

Vaibhavi Behere

HR Department

Titan Laboratories Pvt Ltd

  • 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

    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...

  • Executive Regulatory Affairs

    3 days ago

    Navi Mumbai, Maharashtra, India METSL Full time ₹ 3,00,000 - ₹ 4,00,000 per year

    Dear Candidates,We have job opportunity for the position of Regulatory Affairs Executive & QMR in our leading manufacturing Medical Devices companies.Position:-Regulatory Affairs Executive & Quality Management RepresentativeExperience:-2 to 4 yrsGender:-Male/FemaleThe JD as follows:-· Maintain regulatory files. Maintain and update regulatory authorizations,...

  • Regulatory Affairs

    7 days 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 Executive

    2 weeks ago

    Mumbai, Maharashtra, India Talent Sutra Full time US$ 90,000 - US$ 1,20,000 per year

    Designation:Regulatory affairs -Executive/ Sr. ExecutiveJob Location:MumbaiJob Summary:The primary responsibility for the position is to oversee the daily activities of the Regulatory Affairs. Ensure that deliverables are being met based on planned submission timelines. Directs the development of submission of Product registration Dossiers, amendments, PSUR...

  • Regulatory Affairs Specialist

    4 days ago

    Navi Mumbai, Maharashtra, India beBeeRegulatoryAffairs Full time ₹ 6,00,000 - ₹ 8,00,000

    Regulatory Affairs SpecialistOur organization is seeking an experienced Regulatory Affairs Specialist to join our team. The ideal candidate will have a strong understanding of US FDA regulations and ICH guidelines.Key Responsibilities:• Develop and implement regulatory strategies for new and existing products• Collaborate with cross-functional teams to...

  • Regulatory Affairs Specialist

    2 weeks ago

    Mumbai, Maharashtra, India Win in Life Academy Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Position:Sr. Executive / Asst. Manager / Deputy Manager – Regulatory Affairs (Domestic)Location:Andheri, MumbaiQualification:M. Pharm. (Experienced preferred)Job Description – Regulatory Affairs (Domestic)The role requires strong expertise in theDrugs & Cosmetics Act and Rules,FSSAI regulations, andFDA-related activities. The profile will ensuretimely...

  • Regulatory Affairs Professional

    2 weeks ago

    Mumbai, Maharashtra, India beBeeRegulatoryAffairs Full time ₹ 90,00,000 - ₹ 1,50,00,000

    Regulatory Affairs SpecialistMain Purpose of Role:We are seeking a highly experienced and knowledgeable Regulatory Affairs Specialist to join our team. The ideal candidate will have comprehensive knowledge in the area of Regulatory Affairs and be able to execute complex projects.The Regulatory Affairs Specialist will direct the development of product...

  • Regulatory Affairs Professional

    2 weeks ago

    Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 20,00,000 - ₹ 25,00,000

    Regulatory Affairs Executive RoleJob Summary:We are seeking a highly motivated and experienced Regulatory Affairs professional to join our organization.Main Responsibilities: