Executive Regulatory Affairs

3 - 6 Years
Anand

Job Description

  • To ensure that ensuring that quality standards are met and submissions according regulatory requirements.
  • Regular updates along with changes in regulatory legislation and guidelines.
  • Planning, undertaking and overseeing regulatory inspections.
  • Obtaining marketing permission, COPPs, FSCs and other certificate as required from the FDCA.


    Gathering, evaluating, organizing, managing and information in a variety of formats as per country specific requirements for dossier submissions.


    Liaison with regulatory authorities.


    To provide advice about regulations to the technical staff of the company.


    To provide guidance to the regulatory staff on dossier compilation and addressing of queries during registration.


    Review and approve the documents submitted by vendors (DMF, Specifications, COAs etc) required for dossier submission.


    Outlining regulatory requirements for manufacturing, labeling, storage and packaging studying scientific and legal documents.


    Review and approve the PDL for ensuring that the products manufactured, process and formula used, packing materials used are as per the regulatory submissions.


    To work in interaction with the QA team for internal audits, handling of market recalls, customer complaints (if required), compliance of regulatory audit findings.

    Required Candidate profile

    Key responsibilities of RA Executive/Officer

  • Preparing documents for obtaining marketing permission, COPPs, FSCs and other certificate as required from the FDCA.
  • Compilation & review of documents for dossier submissions.
  • Addressing queries received on dossiers submitted for approvals.
  • Supervising the preparation & submission of registration samples in interaction with the production and QC department.
  • Filing of the office copies of dossiers, certificates and other documents filed with regulatory authorities.
  • Preparation of PDL upon receipt of the regulatory approval.
  • Perks and Benefits

    Best in the Industry

    Keyskills

    Desired Candidate Profile

    Please refer to the Job description above

    Education-

    UG:B.Pharma - Pharmacy, B.Sc - Any Specialization

    PG:Post Graduation Not Required, M.Pharma - Pharmacy

    Company Profile

    Baroque Pharmaceuticals Pvt Ltd

    We are a quality focused manufacturer of pharmaceutical formulations based on Khambhat (Cambay), Gujarat, in India, strongly armed with a big portfolio of oral solid & liquid dosage forms spread across a wide range of therapeutic categories.
    View Contact Details+

    Recruiter Name:Kalpit Darji

    Contact Company:Baroque Pharmaceuticals Pvt Ltd

    Telephone:7574878021

    Address :NH No. 8, At. Vaghasi, Tal & Dist. Anand, ANAND, Gujarat - 388320,India

    Website:http://www.baroquepharma.com

    Salary

    Not Disclosed by Recruiter

    Role Category

    Drug Regulatory Affairs/Documentation

    Role

    Regulatory Affairs Manager

    Employment Type

    Full Time, Permanent