Regulatory Affairs Officer
3 days ago
- 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
-
Regulatory Affairs Officer
5 days ago
Santacruz West, Mumbai, Maharashtra, India Globofarm International Pvt Ltd Full timeJob 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...
-
Regulatory Affairs Officer
2 weeks ago
Mumbai, Maharashtra, India Orbitouch Outsourcing Pvt ltd Full timeDesignation : 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**: -...
-
Regulatory Affairs Officer
5 days ago
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...
-
Regulatory Affairs Executive
2 days ago
Andheri East, Mumbai, Maharashtra, India Career Strategy Solutions Full timeSeeking 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
7 days ago
Mumbai, Maharashtra, India Fusion Market Research Full timeRegulatory 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....
-
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 - 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
2 weeks ago
Mumbai, Pithampur, India Gepach International Full time US$ 80,000 - US$ 1,20,000 per yearResponsibilities 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...