Regulatory Affairs Executive

3 hours ago

Borivali Mumbai Maharashtra, India TheTalentforte.com Full time

Manufacturer of Pharmaceutical Tablets, Oral Suspension & Pharmaceutical Medicines. A dynamic Pharmaceutical company of approximately turnover of US $ 200 million and operating business in more than 50 countries.

**REGULATORY AFFAIRS EXECUTIVE**
**Job Location: BORIVILI**

**QUALIFICATION**
BPharma / MPharma **OR** MSc + Diploma in Drug Regulatory Affairs

**EXPERIENCE**
4 to 5 years in Regulatory Affairs of Pharma Formulations

**JOB PROFILE**
Filing ACTD dossier in ROW/African and Indian Market.
Knowledge of ICH quality guidelines and maintain regular updates.
Application of COPP for exporting country.
Arrangement of Product Samples as per country guidelines/client requirements.
To arrange administrative documents required for dossier submission & export purpose.
Review and maintain regulatory documentation in databases or systems
To Co-ordinate and follow-up with manufacturer for documents & samples/WS required for regulatory submission.
Handling queries pertaining to regulatory submissions from various regulatory authorities.
Maintain record of Samples, Shade Cards and Registration Certificate etc.
Preparation of Package Inserts, Product characteristics and Patient information leaflet.
To check & approve the artworks for regulated / semi regulated countries

**COMPETENCIES REQUIRED**
Good technical knowledge, review skills and understanding of regulatory submissions
Strong knowledge of CTD /eCTD requirements for submission of dossiers
Good analytical and problem-solving skills.
Ability to try new approaches when faced with challenges.
Should have a good analytical and learning attitude.
Proactive to submission of response to any queries.
Excellent communication skills

**If you find this opportunity interesting, Please send us the following**:
Your updated CV
Current or last CTC:
Your Residence location:
Joining Period if you are selected

Regards,

Pooja Nair
TheTalentorte.Com
Pharmaceuticals & Chemicals Recruiter

Schedule:

- Day shift

  • Regulatory Affairs Executive

    3 hours ago

    Borivali, Mumbai, Maharashtra, India RG HR Solutions Full time

    Studying scientific and legal documents - Gathering, evaluating, organising, managing and collating information in a variety of formats - Ensuring compliance with regulations set by the Medicines and Healthcare products Regulatory Agency (MHRA) - Maintaining familiarity with company product ranges - Planning, undertaking and overseeing product trials and...

  • Executive - Regulatory Affairs - Mumbai

    2 days ago

    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 Executive

    7 days 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

    7 days ago

    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 Officer

    1 week ago

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

    **We are hiring Regulatory Affairs for a reputed company.** **We are looking for someone who has experience in** 1. CTD Dossier prepared 2. Someone who follows ICH Guidelines 3. Experience in preparation & review of Regulatory Documents 4. Have experience in Artwork and translation 5. Have experience in gap analysis and quality compliance. **Market...

  • Regulatory Affairs Executive

    7 days ago

    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....

  • Regulatory Affairs Executive

    2 days ago

    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...

  • Regulatory Affairs Executive

    2 weeks ago

    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

  • Executive – Regulatory Affairs

    5 days ago

    Mumbai Metropolitan Region, India Lyka Labs Limited Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Job Title:Executive – Regulatory AffairsLocation: Grant Road, MumbaiReporting To: General Manager – Regulatory AffairsFull-time, 5 Days working.Position Summary:We are seeking a detail-oriented professional to join our Regulatory Affairs team as an Executive. The role involves preparing, compiling, and submitting regulatory documents for product...

  • Regulatory Affairs Executive

    1 week ago

    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 /...