Officer - Regulatory Affairs

2 weeks ago

Dwarka Delhi Delhi, India Harasha Pharma Pvt ltd Full time

Ø Preparation and reviewing of administrative documents.

Ø Preparation and Review of Dossier in CTD, ACTD and ECTD Format.

Ø Preparing the SPC/ Leaflet/ SMPC as per country guidelines.

Ø Preparation of Dossier for CIS, Africa countries, ASEAN, EU, LATAM, ROW and Gulf Countries,.

Ø Review and Making of Stability Data, Analytical Method Validation, Process Development record.

Ø Review of DMF (Close part)

Ø Review of Labels and Literature as per the country guideline

Ø Preparation of COA, MSDS, Packing Specification, Finished Product specification.

Dossier in CTD, ACTD and ECTD Format: 2-5 years (preferred)
REGULATORY AFFAIRS- FINISHED FORMULATION
- Preparation and reviewing of administrative documents.
- Preparation and review of Dossier in CTD, ACTD and ECTD Format.
- Preparing the SPC/ SMPC/ Leaflet as per country guidelines.
- Preparation of Dossier For CIS, Africa countries, ASEAN, EU, LATAM, ROW and Gulf Countries.
- Review and making of stability data, Analytical Method Validation, Process Development record.
- Review of DMF (Close Part, Open Part)
- Review of Labels and literature as per the country guideline
- Preparation Of COA, MSDS, Packing Specification, Finished Product Specification
- To Oversite third party manufacturing quality, COA and Control Samples
- To Co-ordinate with Warehouse, Designer, Cross Functional team
- Having Experience in handling audit of manufacturing site
- Making of STP, Manufacturing Flow Chart
- Preferred From Pharma finished products Background
- Review of Labels and literature artwork

Schedule:

- Day shift
- Monday to Friday
- Morning shift

**Education**:

- Bachelor's (preferred)

**Experience**:

- minimum: 2 years (preferred)

Work Location: In person

  • Regulatory Affairs Officer

    2 weeks ago

    Delhi, India ProductLife Group Full time

    Responsibilities In the context of a project for one of our top Pharma client, we’re looking for 2 talented Regulatory Affairs Officer to lead the following missions, and much more!Compile, or supervise the compilation of regulatory dossiers Provide on-going regulatory advice to project teams to ensure regulatory concerns are planned and accounted for and...

  • Executive - Regulatory Affairs

    2 weeks ago

    Delhi, Delhi, India Domnic Lewis Pvt. Ltd Full time

    **Executive - Regulatory Affairs - Delhi**: **Domnic Lewis has been mandated to hire for Executive - Regulatory Affairs - Delhi** **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 -...

  • Drug Regulatory Affairs

    4 days ago

    Delhi, Delhi, India OM Sai Management Consulting Services Full time

    Designation: - **Drug Regulatory Affairs-Male/Female** **JOB DESCRIPTION: -** - Delivery/Proper packing of goods for supplier - Maintaining the stock status at the back office - Settling of credit notes and following ups of payments from the parties - Coordinate with the vendors by keeping the track on purchase & delivery of orders sent - Maintaining the...

  • Regulatory Affairs Executive

    1 week ago

    Delhi, Delhi, India Oswal Crop Protection Pvt. Ltd. Full time ₹ 6,00,000 - ₹ 12,00,000 per year

    Company DescriptionOswal Crop Protection Pvt. Ltd. is an ISO 9001:2015 certified company, established by Mr. Ramesh Bansal, who has over 30 years of experience in the pesticides industry. As one of the leading agrochemical companies in India, Oswal Crop Protection is committed to strengthening agriculture with sustainable products and services. Our marketing...

  • Regulatory Affairs Executive

    3 weeks ago

    Delhi, India Oswal Crop Protection Pvt. Ltd. Full time

    Company Description Oswal Crop Protection Pvt. Ltd. is an ISO 9001:2015 certified company, established by Mr. Ramesh Bansal, who has over 30 years of experience in the pesticides industry. As one of the leading agrochemical companies in India, Oswal Crop Protection is committed to strengthening agriculture with sustainable products and services. Our...

  • Regulatory Affairs Executive

    2 weeks ago

    Delhi, Delhi, India SAVVI SALES AND SERVICE PVT.LTD. Full time

    Job Title: Regulatory Affairs Executive Location: Rohini, Delhi Industry: Pharmaceuticals / Nutraceuticals Salary Package: ₹25,000 - ₹50,000 per month Gender Preference: Male Experience Required: 2-3 years in Pharma or Nutra Industry (Regulatory Affairs) Key Responsibilities: - Prepare and submit regulatory dossiers such as INDs, NDAs, ANDAs,...

  • Regulatory Affairs Manager

    4 weeks ago

    Delhi, Delhi, India Self-employed Full time

    Company DescriptionFounded in the commercial operations year of 2015-16, NextGen Pharma, a majority-owned subsidiary of Ormendes SA, Switzerland, has emerged as a leading provider of specialized botanical and nutraceutical solutions. With a focus on proprietary Targeted Bacterio-Therapy (TBT), our offerings cater to diverse therapeutic segments ranging from...

  • Regulatory Affairs Executive

    2 weeks ago

    Delhi, Delhi, India SAVVI SALES AND SERVICE PVT. Full time ₹ 2,50,000 - ₹ 3,00,000 per year

    Job Title: Regulatory Affairs ExecutiveLocation: Rohini, DelhiIndustry: Pharmaceuticals / NutraceuticalsSalary Package: ₹25,000 – ₹50,000 per monthGender Preference: MaleExperience Required: 2–3 years in Pharma or Nutra Industry (Regulatory Affairs)Key Responsibilities:● Prepare and submit regulatory dossiers such as INDs, NDAs, ANDAs, MAAs.●...

  • Regulatory Affairs Executive

    3 weeks ago

    Delhi, India Savvi Sales & Services Full time

    Job Title: Regulatory Affairs Executive Location: Rohini, Delhi Industry: Pharmaceuticals / Nutraceuticals Salary Package: 25,000 50,000 per month Gender Preference: Male Experience Required: 2–3 years in Pharma or Nutra Industry (Regulatory Affairs) Key Responsibilities: Prepare and submit regulatory dossiers such as INDs, NDAs, ANDAs, MAAs. Ensure proper...

  • Regulatory Affairs Executive

    2 weeks ago

    Delhi, Delhi, India Savvi Sales & Services Full time ₹ 2,40,000 - ₹ 12,00,000 per year

    Job Title: Regulatory Affairs ExecutiveLocation: Rohini, DelhiIndustry: Pharmaceuticals / NutraceuticalsSalary Package: 25,000 50,000 per monthGender Preference: MaleExperience Required: 2–3 years in Pharma or Nutra Industry (Regulatory Affairs)Key Responsibilities:Prepare and submit regulatory dossiers such as INDs, NDAs, ANDAs, MAAs.Ensure proper...