Regulatory Executive for Registration

5 months ago

Mumbai, India Double HR Consultancy Full time

Mumbai, Vile Parle East
- Share

Position: Regulatory Executive
Job Location: Vile Parle Mumbai: Maharashtra
Eligibility:
M. Sc / B. Sc / M. Pharm / B. Pharm. Degree / Diploma in Regulatory Affairs
Should have good knowledge of preparing registration of Drugs & Feed Supplements in different countries
FDA: Registration and Post-registration activities in the Rest of the world countries (AFRICA, ASIA, Latin America, CIS, Gulf Countries, and South Asia (Afghanistan and Sri Lanka).
Registration dossier submissions as per CTD, ACTD, and National guidelines.
Renewal and variation submission as per countries' guidelines.
Submission of documents for desktop audits, and registration of the manufacturing sites.
Involve in the budgeting - The budget includes site inspections, registrations, and renewals.
Involve in the yearly submission planning - Check guidelines and feasibility to register the products in the new countries.
Coordinate with the internal different departments to get and review the documents for compilation and submission purposes. Coordinate with the labeling team to develop new artwork.
Having good knowledge of CTD, ICH, guidelines.
- Managing regulatory affairs of the organization & its subsidiaries / associates.
- Liaising with regulatory bodies like State and Central FDA, DCI, etc.
- Well conversant with Drug law/feed supplement regulation.
- Coordination with factory, purchase department, marketing department.
- Reviewing of technical documents like process validation, stability, etc.
- Compilation of dossiers and handling dossier-related queries.
- Arranging and checking artworks for registration as per guidelines.
- Compilation and preparation of tender documents.
- Experience- 3 - 5 Years- Salary- 4 Lac To 5 Lac P.A.- Industry- Corporate Planning & Strategy / Management Consulting- Qualification- Diploma, Professional Degree, B.Pharma, B.Sc, M.Pharma, M.Sc- Key Skills- Regulatory Executive for Registration & Renewal of Drugs & Feed SupplementsAbout Company
- Contact Person- Kashinath Jha- Address- B 202, Bhavani Enclave Opp. Anand Old Age Home, New Satpati Road, Shirgaon, Palghar West- Mobile- 9820032472

  • Regulatory Executive for Registration

    5 months ago

    Mumbai, Maharashtra, India Double HR Consultancy Full time

    Mumbai, Vile Parle East, Maharashtra Nagar Position: Regulatory Executive Job Location: Vile Parle Mumbai: Maharashtra Eligibility: M. Sc / B. Sc / M. Pharma / B. Pharma. Degree / Diploma in Regulatory Affairs - Should have good knowledge of preparing registration of Drugs & Feed Supplements in different countries - FDA: Registration and Post-registration...

  • Regulatory Executive

    5 months ago

    Mumbai, Maharashtra, India Double HR Consultancy Full time

    Urgent Requirement Regulatory Executive (Female) (Preparing registration of Drugs & Feed Supplements in different countries) Pharmaceutical Company, Vile Parle East, Mumbai, Maharashtra Eligibility: - M. Sc / B. Sc / M. Pharm / B. Pharm. Degree / Diploma in Regulatory Affairs. - Should have good knowledge of preparing registration of Drugs & Feed...

  • Regulatory Affairs Executive

    5 months ago

    Mumbai, India AMPLE LEAP COGNITION & TECHNOLOGIES PVT LTD Full time

    **Designation**: Executive - Agriculture Regulatory Affairs **Location**: Marol, Mumbai **Experience**: 2 - 5 Years **Qualification**: B.sc Agri/ M.sc Agri/ Diploma in regulatory affairs - Responsible for licensing & registration of agricultural products locally with state Agri department for sales permission, Product inclusions in the State sale...

  • Regulatory Affairs Executive

    2 days ago

    mumbai, India Ipca Laboratories Limited Full time

    Position : Executive - Regulatory affairs formulation for USA market.Qualification : B.Pharm/M.PharmExperience : 4 - 7 years experience of working in regulated markets like USA/ Europe/Australia with experience of ANDA, USA market preferred.Role:Preparation of registration dossiers as per the US Regulatory guidelinesPreparation of renewal application as...

  • Regulatory Affairs Executive

    4 weeks ago

    mumbai, India Ipca Laboratories Limited Full time

    Position : Executive - Regulatory affairs formulation for USA market.Qualification : B.Pharm/M.Pharm Experience : 4 - 7 years experience of working in regulated markets like USA/ Europe/Australia with experience of ANDA, USA market preferred.Role:Preparation of registration dossiers as per the US Regulatory guidelines Preparation of renewal application as...

  • Regulatory Affairs Executive

    14 hours ago

    mumbai, India Ipca Laboratories Limited Full time

    Position : Executive - Regulatory affairs formulation for USA market.Qualification : B.Pharm/M.PharmExperience : 4 - 7 years experience of working in regulated markets like USA/ Europe/Australia with experience of ANDA, USA market preferred.Role:- Preparation of registration dossiers as per the US Regulatory guidelines- Preparation of renewal application as...

  • Regulatory affairs executive

    4 weeks ago

    Mumbai, India Ipca Laboratories Limited Full time

    Position : Executive - Regulatory affairs formulation for USA market. Qualification : B. Pharm/M. Pharm Experience : 4 - 7 years experience of working in regulated markets like USA/ Europe/Australia with experience of ANDA, USA market preferred. Role: Preparation of registration dossiers as per the US Regulatory guidelines Preparation of...

  • Regulatory Affairs Executive

    1 day ago

    mumbai, India Ipca Laboratories Limited Full time

    Position : Executive - Regulatory affairs formulation for USA market. Qualification : B.Pharm/M.Pharm Experience : 4 - 7 years experience of working in regulated markets like USA/ Europe/Australia with experience of ANDA, USA market preferred. Role: - Preparation of registration dossiers as per the US Regulatory guidelines - Preparation of renewal...

  • Regulatory Affairs Executive

    5 months ago

    Mumbai, India Morpheus Human Consulting Full time

    Reference Code: - 319-58 - Job Title: **Regulatory Affairs Executive - Animal Health Care - Mumbai** - Category: - Manufacturing - Job Description: - Job Title: Regulatory Affairs Executive - Vile Parle - Mumbai - **Job Description**: - Managing regulatory affairs of the organization & its subsidiaries / associates. - Liaising with regulatory bodies like...

  • Regulatory Affairs Executive

    5 months ago

    Navi Mumbai, India METSL Full time

    We have job opportunity in our leading manufacturing company of Medical devices Position: - Regulatory Affairs Executive Experience: - 2 to 4 Yrs The JD as follows: - Maintain regulatory files. Maintain and update regulatory authorizations, such as IDEs, Medical device licenses, and CE dossiers for certifications etc. - Documenting technical file for...

  • Regulatory Affairs Executive

    3 days ago

    mumbai, India Ipca Laboratories Limited Full time

    Position : Executive - Regulatory affairs formulation for USA market.Qualification : B.Pharm/M.PharmExperience : 4 - 7 years experience of working in regulated markets like USA/ Europe/Australia with experience of ANDA, USA market preferred.Role:- Preparation of registration dossiers as per the US Regulatory guidelines- Preparation of renewal application as...

  • Regulatory Affairs Executive

    3 days ago

    Mumbai, India Ipca Laboratories Limited Full time

    Position : Executive - Regulatory affairs formulation for USA market.Qualification : B.Pharm/M.PharmExperience : 4 - 7 years experience of working in regulated markets like USA/ Europe/Australia with experience of ANDA, USA market preferred.Role:- Preparation of registration dossiers as per the US Regulatory guidelines- Preparation of renewal application as...

  • Regulatory affairs executive

    1 week ago

    Mumbai, India Ipca Laboratories Limited Full time

    Position : Executive - Regulatory affairs formulation for USA market.Qualification : B. Pharm/M. PharmExperience : 4 - 7 years experience of working in regulated markets like USA/ Europe/Australia with experience of ANDA, USA market preferred.Role:Preparation of registration dossiers as per the US Regulatory guidelinesPreparation of renewal application as...

  • Regulatory Affairs Executive

    1 month ago

    Mumbai, India Ipca Laboratories Limited Full time

    Position: Executive - Regulatory affairs formulation for USA market.Qualification: B.Pharm/M.PharmExperience: 4 - 7 years experience of working in regulated markets like USA/ Europe/Australia with experience of ANDA, USA market preferred.Role:Preparation of registration dossiers as per the US Regulatory guidelinesPreparation of renewal application as per...

  • Regulatory Affairs Executive

    5 months ago

    Mumbai, India AMPLE LEAP COGNITION & TECHNOLOGIES PVT LTD Full time

    **Job Description Form** **Fields** **Required Information** **Job Title** **Executive - Agriculture Regulatory Affairs** Reports To Manager Position Type New position Location Marol, Mumbai Job Overview Planning, undertaking, and overseeing regulatory work for local & export related products in Agri and Scientific support Responsibilities and...

  • Executive Regulatory Affairs

    5 months ago

    Mumbai, India Ample Leap Cognition & Technologies Pvt Ltd Full time

    **Job Description Form** **Fields** **Required Information** **Job Title** **Executive - Agriculture Regulatory Affairs** Reports To Manager CTC Budget 3-4 LPA Position Type New position Location Marol, Mumbai Job Overview Planning, undertaking, and overseeing regulatory work for local & export related products in Agri and Scientific...

  • Regulatory Affairs Executive

    1 month ago

    Mumbai, India Ipca Laboratories Limited Full time

    Position : Executive - Regulatory affairs formulation for USA market.Qualification : B.Pharm/M.Pharm Experience : 4 - 7 years experience of working in regulated markets like USA/ Europe/Australia with experience of ANDA, USA market preferred.Role:Preparation of registration dossiers as per the US Regulatory guidelines Preparation of renewal application as...

  • Regulatory Affairs Executive

    4 weeks ago

    mumbai, India Ipca Laboratories Limited Full time

    Position : Executive - Regulatory affairs formulation for USA market. Qualification : B.Pharm/M.Pharm Experience : 4 - 7 years experience of working in regulated markets like USA/ Europe/Australia with experience of ANDA, USA market preferred. Role: Preparation of registration dossiers as per the US Regulatory guidelines Preparation of renewal...

  • Regulatory Affairs Executive

    1 month ago

    mumbai, India Ipca Laboratories Limited Full time

    Position : Executive - Regulatory affairs formulation for USA market.Qualification : B.Pharm/M.Pharm Experience : 4 - 7 years experience of working in regulated markets like USA/ Europe/Australia with experience of ANDA, USA market preferred.Role:Preparation of registration dossiers as per the US Regulatory guidelines Preparation of renewal application as...

  • Regulatory Affairs Executive

    1 month ago

    Mumbai, India Ipca Laboratories Limited Full time

    Position : Executive - Regulatory affairs formulation for USA market.Qualification : B.Pharm/M.Pharm Experience : 4 - 7 years experience of working in regulated markets like USA/ Europe/Australia with experience of ANDA, USA market preferred.Role:Preparation of registration dossiers as per the US Regulatory guidelines Preparation of renewal application as...