Regulatory Affairs

3 weeks ago

Mumbai, India CliniLaunch Research Institute Full time

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 with

experience in FDA related activities. This profile will ensure timely and robust functional/cross-functional coordination (R&D, QC, Marketing, Legal, Production, etc.), transparent execution

and implementation of regulatory affairs and safety processes.

Local Regulatory Function (Licensing):

  • Prepare registration dossier for procuring certificates/license from local FDA, DCGI and
  • FSSAI. This would entail thorough familiarity with FDA, Sugam & FSSAI online portal, Drugs
  • & Cosmetics Act and its various Schedules e.g. Sch Y, M, etc.
  • Confirm product formula and label acceptability, as well as the receipt of necessary licenses,
  • prior to the release of product.
  • Co-ordinate with QC and R&D departments for technical documents (manufacturing
  • documents like batch records, specifications, analytical methods, validation reports, and
  • stability data) required to be incorporated in the registration dossiers.
  • Ensure timely renewal of drug and food licenses maintained by head office and also branch
  • offices based at various states in the country.
  • Online application for obtaining test license for import purpose.
  • Maintain archival of all regulatory permissions.
  • Keep abreast of the updates pertaining to regulatory requirements and accordingly
  • implement them.
  • Prepare responses to the legal & technical queries raised by the Regulatory authorities.

Compliance of Packaging Modules:

  • Formulate and implement statutory requirements pertaining to the artworks of the
  • products (label, carton, package insert, patient information leaflet, etc.).
  • Review the artwork of all packaging material.
  • Prepare package insert as per New Drugs and Clinical Trials Rules 2019.
  • Pharmacovigilance
  • Provide high quality medical writing from planning and coordination of literature research.
  • Draft and review PSURs with focus on medical aspects of the products and safety sections.
  • Review of Risk Management Plans as per Regulatory requirement.
  • Good knowledge in assessing the risk-benefit of a product and identify any gaps in the
  • aggregate documents.
  • Perform scientific review of aggregate reports / ICSRs produced by PV Associates.

  • Regulatory Affairs

    1 week ago

    Mumbai, Pithampur, India Gepach International Full time US$ 80,000 - US$ 1,20,000 per year

    Responsibilities of a Regulatory Affairs - Manager for HOD / Senior RA Executives :Manages all the functions of the Regulatory Affairs Department including but not limited to * Scheduling activities of the department.1. Dossier Preparation and ReviewOversee the preparation of technical product dossiers, ensuring accuracy, completeness, and compliance with...

  • Regulatory Affairs

    3 weeks ago

    Mumbai, India Win in Life Academy Full time

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

  • 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 ₹ 5,00,000 - ₹ 15,00,000 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...

  • Regulatory Affairs Executive

    13 hours ago

    Mumbai, Maharashtra, India R. Wadiwala Sec Pvt Ltd Full time

    Designation : Regulatory Affairs Specialist - Qualifications : Bachelor's degree in a scientific discipline, such as pharmacy, biology, or chemistry - Experience : Minimum 2-5 years of experience in regulatory affairs - Salary : Good Hike on Current CTC - Location : Sandhurst Road Mumbai - Head

  • Regulatory Affairs Executive

    2 weeks ago

    Mumbai, India Amico Formulations LLP Full time

    **Post**: RA Executive **Experience**: 5+ Years Experience in Regulatory Affairs in Pharma Industry (Formulation) **Location**: Masjid Bunder, Mumbai - Experience in handling regulatory affairs for ROW market mainly Central and Latin American, African & Asian countries for Pharma Formulations. - Preparation, Compilation & Review of Registration documents...

  • Regulatory Affairs Executive

    2 weeks ago

    Andheri East, Mumbai, Maharashtra, India Career Strategy Solutions Full time

    Seeking Drug Regulatory Affairs for a Company into Pharma Industry **Key Responsibilities**: - Research and stay updated on regulatory requirements and guidelines - Coordinate with cross-functional teams to gather necessary documentation and information for regulatory filings - Review and assess product labeling, packaging, and promotional materials to...

  • Office Regulatory Affairs

    3 weeks ago

    Mumbai, India Kremoint Pharma Full time

    Job Title / DesignationOffice Regulatory Affairs Organization NameKremoint Pharma Pvt. Ltd. Job LocationVikhroli Job Description / Responsibilities Prepare and compile dossiers for CTD, ACTD, and country-specific requirements for in-house, loan license, and third-party products for the ROW market. Apply for Free Sale Certificate (FSC) and Product Permission...

  • Office Regulatory Affairs

    2 weeks ago

    Mumbai, Maharashtra, India Kremoint Pharma Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Job Title / Designation Office Regulatory AffairsOrganization Name Kremoint Pharma Pvt. Ltd.Job Location VikhroliJob Description / ResponsibilitiesPrepare and compile dossiers for CTD, ACTD, and country-specific requirements for in-house, loan license, and third-party products for the ROW market.Apply for Free Sale Certificate (FSC) and Product Permission...

  • Regulatory Affairs Officer

    6 days ago

    Mumbai, India Glendale Biomed Pvt. Ltd Full time

    **Vacancy**: For Regulatory affairs officer **Job description** **Roles and Responsibilities** 2) To check artworks for regulated/ semi regulated countries. 3) To co-ordinate for documents and samples for regulatory submissions with manufacturing locations LL & TP 4) Handling of queries pertaining to regulatory submissions from various regulatory...