Executive Regulatory Affairs

3 weeks ago


Mumbai Maharashtra, India EDGEPHARMA Full time

1) Complete understanding of requirements & regulations of ASEAN/ AFRICA/LATAM/ GCC/ MENA markets wrt New submissions, Re-registration & Variations.

2) Prior experience of carrying out high quality CMC review of all kind of technical documentation & Art-works,

3) Review and /or Compilation of country specific/ CTD/ACTD dossiers for new submissions & renewal.

3) Variations submission

4) Must be an Individual contributor + Good team player.

Specific requirements:
1) Collate, compile & author high quality CTD sections for M1, M2, M3, M4 & M5.

2) Detailed review of technical documents required for Regulatory submissions e.g. PVP/PVR/AMV/Stability report & Protocol/Specifications/ COAs/ BE study/ DMF etc.

4) Utmost care is recommended to minimize the unwanted errors while working with documents i.e. authoring & reviewing the data.

**Must have Key Skills**: CTD/ ACTD/ CMC/ technical review/ Dossier/ MOH queries/ Variations/ Renewals

**Other essential skills**: LATAM/ GCC/ MENA/ SEA/AFRICA/ change control/ Art work checking

**Job Types**: Full-time, Permanent

**Salary**: Up to ₹500,000.00 per year

**Benefits**:

- Leave encashment
- Provident Fund

Schedule:

- Day shift

Supplemental pay types:

- Yearly bonus

**Education**:

- Bachelor's (preferred)

**Experience**:

- Regulatory Affairs: 3 years (required)
- total work: 4 years (required)



  • Mumbai, Maharashtra, India Double HR Consultancy Full time

    VACANCY REGULATORY AFFAIRS EXECUTIVE (Pharma Company is manufacturing veterinary products) Job Location: 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 - Minimum 2 years experience in...


  • 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...


  • 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,...


  • Mumbai, India Kenvue Full time

    **Executive, Regulatory Affairs**-2307003094W Description Kenvue, part of the Johnson & Johnson Family of Companies (Kenvue), is currently recruiting for: Executive Regulatory Affairs **Job Description General Header Statement** This position reports into Manager Regulatory Affairs and is based at Mumbai. **Who we are** At Kenvue, part of the Johnson &...


  • Mumbai, Maharashtra, India Double HR Consultancy Full time

    Female - Urgent: Regulatory Affairs Executive(Female)/ Pharmaceutical Mumbai, Vile Parle Share VACANCY REGULATORY AFFAIRS EXECUTIVE (Pharma Company is manufacturing veterinary products) Job Location: Mumbai Maharashtra Eligibility: - M. Sc / B. Sc / M. Pharm / B. Pharm. Degree / Diploma in Regulatory Affairs. - Should have good knowledge of preparing...


  • Mumbai, India Morpheus Human Consulting Full time

    Reference Code: 319-54 Job Title: **Regulatory Affairs Executive - Animal Health Care - Mumbai** Category: Manufacturing **Job Description**: Our client is one of the leading Manufacturing company of Animal Healthcare Products since 1977. They have around 20 dedicated sales offices in India. They market wide range of poultry and cattle products. They are...


  • Mumbai, India Morpheus Human Consulting Full time

    Reference Code: - 319-54 - Job Title: **Regulatory Affairs Executive - Animal Health Care - Mumbai** - Category: - Manufacturing - Job Description: - Our client is one of the leading Manufacturing company of Animal Healthcare Products since 1977. They have around 20 dedicated sales offices in India. - They market wide range of poultry and cattle products....


  • Worli, Mumbai, Maharashtra, India RecruitApt Full time

    Looking for RA Executive having min 2 years of Experience **Salary**: ₹40,000.00 - ₹50,000.00 per month Schedule: - Day shift **Experience**: - Regulatory Affairs: 2 years (required) Work Location: In person **Speak with the employer** +91 8002870884


  • 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 Double HR Consultancy Full time

    VACANCY REGULATORY AFFAIRS EXECUTIVE (Pharma Company is manufacturing veterinary products) Job Location: 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 - Minimum 2 years experience in...


  • Mumbai, India SourceGrids Consulting LLP Full time

    One of our key client is a leading pharmaceutical company headquartered in Mumbai is conducting interview drive for "Regulatory Affairs Executive" role at Dadar office. Interview date and timing - 2nd August'23 between 2 to 5 PM Job role - Regulatory Affairs Executive Experience - 3+ Years Job location - Dadar East, Mumbai Industry - Pharmaceutical /...


  • 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...


  • 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...


  • 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...


  • Goregaon, Mumbai, Maharashtra, India Fast Track Jobs Full time

    We Requires 2 **Regulatory Affairs Executive** for **Pharma **Company at **Goregaon**: - West **Designation**:Regulatory Affairs Executive** Experience : 1 to 3 Years **Education**:B Pharm / M Pharm **[**Compalsary **] Salary : up to 30K Location**:Goregaon**: - **West** **Responsibilities**: - Preparing and submitting the relevant regulatory...


  • Mumbai, Maharashtra, India Apotex Pharmachem India Pvt Ltd Full time

    Apply for Executive Regulatory Affairs, Regulatory Intelligence, Career Progress Consultants in Mumbai for 3 - 6 Year of Experience on


  • Mumbai, Maharashtra, India Apotex Pharmachem India Pvt Ltd Full time

    Apply for Executive Regulatory Affairs, Regulatory Intelligence, Career Progress Consultants in Mumbai for 3 - 6 Year of Experience on


  • Mumbai, India Double HR Consultancy Full time

    Mumbai, Vile Parle, Dombivli East Regulatory Affairs Executive 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 - Minimum 2 years experience in the same industry. **Job Description**: - Managing regulatory...


  • 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...


  • Pune, Maharashtra, India Nissar Transformers Pvt Ltd Full time

    Position - Regulatory Affairs (RA) Executive Location - pirangut Experience - 1 to 3 yrs **Responsibilities**: Strategy & Planning: Develop regulatory strategies for product approvals. Guide project teams on regulatory needs. Submissions: Prepare and submit regulatory documents (e.g., INDs, NDAs). Ensure timely and accurate...