Job Opening: Regulatory Affairs: Mumbai
1 week ago
The Company Leading with Pharma and Chemical company for their office in Mumbai.
**Role: Regulatory Affairs: Mumbai**
**Job Description**:
**The position is responsible for Regulatory Affairs department where the person shall be responsible for the preparation, review and submission of API DMFs, LCM activities, Deficiency responses and customer support for the assigned molecules for global markets.
- DMF Submission:
Compilation, review and submission of the DMF's for various regulatory agencies across the globe including US, EU, Canada, Japan, TGA, Russia, China and other ROW markets.
- Life Cycle Management:
Compilation, review and submission of DMF Amendments, Annual Reports and Life Cycle management for all the regulatory filings as per regional requirement and to ensure the regulatory compliance.
- Deficiency Response
Evaluation of the regulatory queries and drafting, compilation and submission of the DMF Deficiency response/clarification received from various regulatory agencies.
- Customer Support
To address and provide customer support by providing the regulatory documentations including DMF AP, declarations, LOAs, customer queries etc.
- Change Management
Assessment of changes proposed and provide the regulatory strategy followed by customer notification and implementation.
Current Company
- Current CTC
- Expected CTC
- Notice Period- Role:
Pharmacist
- Salary:
Not Disclosed by Recruiter
- Industry:
Pharmaceutical & Life Sciences
- Functional Area
Healthcare & Life Sciences
- Role Category
Other Hospital Staff
- Employment Type:
Full Time, Permanent
- Key Skills
regulatory affairs
API
life cycle
regulatory compliance
change management
Deficiency response
RA
LCM
CMC
Regulatory Awareness
annual reports
dmf
WHO
Skills highlighted with ‘‘ are preferred keyskills
- Education
- PG:
MS/M.Sc(Science) in Any Specialization
Company Profile
- TopGear Consultants Pvt Ltd.
- Leading clients of TopGear Consultants Private Limited.
-
Executive - Regulatory Affairs, Mumbai
24 hours ago
Mumbai, Maharashtra, India Johnson & Johnson Full time**Job Function**: Regulatory Affairs Group **Job Sub Function**: Regulatory Product Submissions and Registration **Job Category**: Professional **All Job Posting Locations**: Mumbai, India - Archival for documents like approvals, query letters etc in appropriate manner - Sharing NMRA updates. - Support operational activities for product registrations in...
-
Regulatory Affairs Executive
2 weeks 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...
-
Regulatory Affairs Executive
5 days ago
Mumbai, India URRI HR Full time**Roles and Responsibilities** **Position :Regulatory Affairs Executive** **Qualification**:Graduation+ PG diploma in Regulatory Affairs**Experience **:0to 2 Years**Location **:Dombivali, Mumbai(Experienced or fresh) will be required for the expansion of the Regulatory department. The expansion of the department is necessary to cater to the requirements...
-
Regulatory Affairs Executive
5 days ago
Masjid, Mumbai, Maharashtra, 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...
-
Regulatory Affairs Officer
3 days ago
Mumbai, India Agile Consultants Full time**Job Code**:047/001/753 **Location**:Mumbai **Salary**:Based on experience **Industry**:Chemical Manufacturing Our client is hiring an experienced Regulatory Affairs Officer who can provide guidance and support sites with the implementation of Raw Materials such as Lubricant Additives, Epoxy Paints & Coatings, Rubber/Carbon Black, Coating, Foam, and...
-
Mumbai, India Double HR Consultancy Full timeMumbai DESCRIPTION **Job Description**: - 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. - Co-ordination with factory, purchase department, marketing department. - Reviewing of technical...
-
Regulatory Affairs Specialist
4 weeks ago
Mumbai, India OrbiTouch HR (orbiTouch outsourcing pvt ltd) Full timeJob Description Designation : Regulatory Affairs Specialist Qualifications: Bachelor's degree in a scientific discipline, such as pharmacy, biology, or chemistry Experience : Minimum 4 years of experience in regulatory affairs Salary : good hike on current salary Location : Sandhurst Road Mumbai - Head office Essential Duties and Responsibilities: -...
-
Regulatory Affairs Executive(Female)
3 days ago
Mumbai, Maharashtra, India Double HR Consultancy Full timeVACANCY 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...
-
Regulatory Affairs Officer
2 weeks 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...
-
Mumbai, India Double HR Consultancy Full timeMumbai 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...