Regulatory Affairs Officer

3 days ago


Andheri West Mumbai Maharashtra, India Oxford Laboratories Pvt Ltd Full time ₹ 40,00,000 - ₹ 1,20,00,000 per year
  • Oxford currently Looking for – Regulatory Affairs Officer for Mumbai H.Q.

Roles and Responsibilities:

The Regulatory Affairs Officer will provide support to the Regulatory Affairs Manager and assist in -

  • Independent preparation of CTD dossier along with complete regulatory compilation like Notarized / Apostle documents, registration samples etc. for timely registration of the products.
  • Preparation of Certificate of Analysis (COA) and other technical documents for Export.
  • Any queries in this regard either from Authorities of these countries, directly or through country head, as well as from the manufacturers of such products should be coordinated by you.
  • Maintaining Records related to regulatory documents
  • Verifying dossier related documents received from plant, FnD or outside agencies
  • Searching and Gathering documents of Innovator product.
  • Should have knowledge for pharmacovigilance and will be coordinating with the pharmacovigilance service providers and maintaining the complete activities regarding pharmacovigilance.

Job Qualifications and Skill Sets:

  • A Pharma Graduate or Post Graduate with a minimum of 2-3 years of relevant experience in Pharma Industry
  • Excellent written and verbal communication skills.
  • Proficient in Microsoft Office (Word, Excel)

Website :

Job Type: Full-time

Benefits:

  • Flexible schedule
  • Health insurance
  • Leave encashment
  • Provident Fund

Application Question(s):

  • What is your Current Annual CTC ?
  • What are your expectations in terms of salary ?
  • What is your Notice Period?

Education:

  • Bachelor's (Required)

Experience:

  • Regulatory reporting: 1 year (Required)

Work Location: In person



  • Santacruz West, Mumbai, Maharashtra, India Globofarm International Pvt Ltd Full time

    Job Profile - Regulatory Affairs (FSSAI) Position Regulatory Affairs - FSSAI Compliance Location Santacruz West mumbai Reports To Head - Director Role Purpose To ensure that all nutraceutical, pharmaceutical ingredients, oils, botanicals, and food products marketed/imported/distributed by the company are fully compliant with FSSAI regulations and other...


  • Mumbai, Maharashtra, India Orbitouch Outsourcing Pvt ltd Full time

    Designation : Regulatory Affairs Specialist Qualifications: Bachelor's degree in a scientific discipline, such as pharmacy, biology, or chemistry Experience : Minimum 8 years of experience in regulatory affairs Salary : As per industry Location : Sandhurst Road Mumbai - Head office **Job Summary**: **Essential Duties and Responsibilities**: -...


  • Mumbai, Maharashtra, 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...

  • Regulatory Affairs

    1 week ago


    Andheri, Mumbai, Maharashtra, India The Hiring Experts Full time

    **Job Title: Regulatory Affairs for a reputed pharmaceutical company** 1. Review all technical documents for submission of ANDA submission and post-approval submissions. 2. Ensuring all compiled ANDAs comply with current FDA guidelines and expectations to minimize deficiencies. 3. Preparation and review of pre-ANDA meeting packages, and controlled...


  • 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...


  • Mumbai, Maharashtra, India Fusion Market Research Full time

    Regulatory affairs officers ensure that products such as foods, cosmetics, pharmaceuticals and veterinary medicines - and the steps involved in developing, testing and marketing them - meet legislative requirements. **Typical duties include**: - studying scientific and legal documents to check they meet legal requirements. - gathering, evaluating,...

  • Regulatory Affairs

    2 weeks ago


    Mumbai, Maharashtra, India Clini launch Business Solutions 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....


  • Mumbai, Maharashtra, India CP HR Services Pvt.Ltd Full time

    **Company Name**: Anmol Chemicals - **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


  • Mumbai, Maharashtra, India Domnic Lewis Pvt. Ltd Full time

    **Executive - Regulatory Affairs - Mumbai**: **Domnic Lewis has been mandated to hire for Executive - Regulatory Affairs - Mumbai** **Position Title**: Executive - Regulatory Affairs **Grade**: C **Reports to**: Lead/Manager - Regulatory Affairs **Position Purpose**: - Monitor and report the status of all product licenses in a timely and accurate manner -...

  • Regulatory Affairs

    2 weeks 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...