Regulatory Affairs Api Role with Rusan Pharma
5 months ago
We have Excellent Job Opportunity for Regulatory Affairs Role (API), Kandivali.
**KRA:
- **To ensure the preparation, review and filing of annual reports, supplements, variations and periodic reports, for all approved products**
- **Timely Response of DMF deficiencies.**
**Job Responsibility:
- Planning, execution, review and submission of Drug Master File (DMF) for Regulated ,Semi Regulated & other geographical markets in CTD/eCTD format.
- Cross-functional meeting & satisfactorily addressing the deficiencies conveyed by the regulatory agencies with adequate data and within stipulated timeline.
- Compilation, review and submission of DMF amendments
- Interaction with cross functional team members of R&D, Marketing, QC, QA, Production and Purchase department on various commercial/technical issues, documentation as required for responding to queries etc.
- Provide notifications to clients for the prior-approval and annual changes. Arrange acceptance from client, schedule submissions to meet assigned goal by organization.
- Consolidate the submission plan in coordination with the business teams and ensure global regulatory filings as per the business plan.
- Review the Drug Master Files prepared by Plant Regulatory teams to ensure the submission requirements in respective countries/customer.
- Provide the inputs to the team for defining the regulatory strategy for post-approval changes with respect to specifications and methods, manufacturing process, alternate manufacturing sites, rationalized products to ensure timely support for their approvals and keep the customer updated on active and Inactive dmfs.
- Maintain and update the tracker for shared dmfs to customers, deficiency response to agencies, issued loas, shared change proposals.
**SKILLS & ABILITIES:
- M.Sc. / M. Pharmacy with 5 + years of work experience
- Hands on experience of API DMF preparation
- **Current guideline requirement awareness**:
- Advance Verbal and Written communication skills.
- Complete understanding of API global regulatory affairs
- Should have knowledge in Analytical, Quality, cGMP, Manufacturing & IP
- **Strong understanding of API development, manufacturing processes, and quality control systems.**:
- ** Detail-oriented with a high degree of accuracy and ability to work under pressure.**:
- ** Ability to multitask and prioritize tasks effectively.**
If you are not interested but know someone who might be interested, we would welcome the recommendations
- Role:
Regulatory Affairs Compliance
- Salary:
6-7 Lacs P.A.
- Industry:
Pharmaceutical & Life Sciences
- Department:
Legal & Regulatory
- Role Category:
Corporate Affairs
- Employment Type:
Full Time, Permanent
- Key Skills
Regulatory Affairs API
API global regulatory affairs
API DMF preparation
regulatory affairs
Skills highlighted with ‘‘ are preferred keyskills
- Education
- PG:
MS/M.Sc(Science) in Any Specialization
Company Profile
- Rusan Pharma
- Rusan is a research driven pharmaceutical company having its Manufacturing Units in India and Worldwide Marketing of Pharmaceutical Formulation, Active Pharmaceutical Ingredients and Intermediates. The company has its own Research & Development centre at Kandivli (west), Mumbai, state of the art, Bulk Manufacturing Plant at Ankleshwar and Formulation plant at Dehradun and SEZ, Kandla having approval of MHRA (UK), MCC (SA) and other International Health Authorities. March 2008 - 82 Crs., Expected by March 2009 €“ 150 Crs.
Contact Company:
Rusan Pharma
Address:
58-D,GOVT INDUSTRIAL ESTATE, MUMBAI, Maharashtra, India
-
Career Opportunity with Rusan Pharma in
5 months ago
Mumbai, India Rusan Pharma Full time**Greetings!** **Industry**:Pharma (Formulations) **Market**:Export / International ( ANZ, Canada ,Latam, Europe, SEA, CIS, MENA) **Experience**:18 + **CTC**:25 LPA **Job Responsibility**: - Develop the vision and strategy for expanding business in LATAM, Europe, MENA, SEA, CIS. - Maintain all company distributors for all assign territories and perform...
-
Sales Admin
5 months ago
Mumbai, India Rusan Pharma Full time**Job Responsibility: - SFA-Analysis and Reports to Management SFA-Addition/Deletion/Follow-up - SAP / SanEforce updating of Basic Data - SPR/Sample Accounting Control - Assisting Head HR/ Field HR / BU Head with his follow-ups - Full & Final settlement follow-up and papers - Field due/review/overdue of Appraisals. - Training programs letters & follow up -...
-
Career Opportunity in Tender Business
4 months ago
Charkop, Mumbai, Maharashtra, India Rusan Pharma Full time**We are looking Executive Tender / Institutional Business in our Kandivali HO.** **Qualification : B.Sc/ B.Pharma / Any Graduate.** - Track relevant tenders through various sources such as online search engines, industry and market intelligence data etc., which are needed for submission - Fill tenders accurately and timely and submit on time - Knowledge of...
-
Digital Marketing Executive
4 months ago
Mumbai, India Rusan Pharma Full time**Roles and Responsibilities** **Job brief**: We are looking for an experienced Digital Marketing Executive/Sr. Executive to assist in the planning, execution and optimization of our online marketing efforts for Navicare clinic Experience in the field of healthcare industry will be an added advantage. He/She should be will be well versed in the concepts...
-
Regulatory Affairs Executive/ Veterinary Pharma
4 months 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...
-
Head of Regulatory Affairs
5 days ago
Mumbai, Maharashtra, India Jones Recruit Zo Full timeJob Title: Head - Regulatory Affair - PharmaJob Description:Job Summary:The Head of Regulatory Affairs will be responsible for overseeing all regulatory aspects of our product development, manufacturing, and marketing processes. This role involves ensuring compliance with the Food Safety and Standards Authority of India (FSSAI), Legal Metrology, the...
-
Regulatory Affairs Officer
5 months ago
Mumbai, Maharashtra, India TheTalentforte.com Full timeWe are looking for **REGULATORY AFFAIRS OFFICER** - BPharma / MPharma / BSc / MSc - 1 - 2 years experience in Regulatory Affairs or relevant (_Freshers please do not apply_) - English Speaking is a Must - Work Timings: Mon to Sat, 10am to 6pm (2nd & 4th sat off) - Salary 18 to 22000 PM, depending on suitability **Should be able to handle**: 1. Preparation,...
-
Regulatory Affairs Specialist
2 weeks ago
Mumbai, Maharashtra, India BEST-FIT Recruitment Riders Full timeJob Profile:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at BEST-FIT Recruitment Riders. The ideal candidate will have a strong background in regulatory affairs, with experience in product registration, document preparation, and submission to regulatory authorities.Responsibilities include collection and preparation of...
-
Regulatory Affairs Associate
5 months ago
Mumbai, Maharashtra, India Planet Science Full time**About Us**: An established player in the B2B Pharma raw material space has recently launched an exciting new E-commerce platform **- CLYZO** **Position - Regulatory Affairs Associate.** An organization with a reputed history of 10+ years in the Pharma raw material industry, dealing in excipient products is looking for Regulatory Affair Executive having...
-
Regulatory Affairs Executive
5 months ago
Sion, Mumbai, Maharashtra, India Fast growing pharma company Full timePlease find JD for Regulatory Affairs (ROW Market formulation): 1. Preparation of Dossier in CTD, ACTD and country specific format. 2. Resolving queries received from various Ministry of Health. 3. Preparation of Technical master file for Medical Device. 4. Finalization of Artwork as per Country specific guidelines. 5. Co-ordination with vendors for DMF...
-
Regulatory Affairs Officer
2 months ago
Mumbai, Maharashtra, India TheTalentforte.com Full timeManufacturer of Bio-Pharmaceuticals, Soft Gel Capsules & Multi-Vitamins **REGULATORY AFFAIRS** Job Location: Borivali West **Experience: Min. 2 years in Pharma Formulations** - Conduct quality assurance activities to ensure compliance with regulatory requirements. - Manage regulatory audits by providing necessary documentation and support. - Maintain...
-
Regulatory Affairs Executive
5 months ago
Mumbai, India Morpheus Human Consulting Full timeReference 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
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...
-
Head of Regulatory Affairs
1 week ago
Mumbai, Maharashtra, India Jones Recruit Zo Full timeJob Summary:The Head of Regulatory Affairs will be responsible for overseeing all regulatory aspects of our product development, manufacturing, and marketing processes. This role involves ensuring compliance with the Food Safety and Standards Authority of India (FSSAI), Legal Metrology, the Advertising Standards Council of India (ASCI), and managing Extended...
-
Head - Regulatory Affair - Pharma
2 months ago
Mumbai, India Jones Recruit Zo Full timeJob Summary:The Head of Regulatory Affairs will be responsible for overseeing all regulatory aspects of our product development, manufacturing, and marketing processes. This role involves ensuring compliance with the Food Safety and Standards Authority of India (FSSAI), Legal Metrology, the Advertising Standards Council of India (ASCI), and managing Extended...
-
Regulatory Affairs Executive
5 months ago
Goregaon, Mumbai, Maharashtra, India Fast Track Jobs Full timeWe 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...
-
Regulatory Affairs Executive(Female)
5 months 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...
-
Executive Assistant
2 weeks ago
Mumbai, Maharashtra, India Talent Corner Full timeKey Responsibilities:We are seeking a highly skilled Regulatory Affairs Coordinator to join our team at Talent Corner. The successful candidate will be responsible for:Coordinating with the MOH for herbal and pharma product documentation filing, particularly for CIS products.Preparing product label artworks and ensuring compliance with FDA...
-
mumbai, India Unichem Laboratories Limited Full timeJob description Responsibilities Compile and submit registration dossiers and eCTD submission (ACTD / ASMF / CDMF / CEP / JDMF / KDMF / USDMF / TD Brazil/ Technical Package) to the international health authorities and customers. Prepare LOA (DMF) / LOE / LOC & other declarations as per customer's requirement & handle queries received from Bulk Drug...
-
Executive / Senior Executive- Regulatory Affairs API
2 months ago
mumbai, India Unichem Laboratories Limited Full timeJob description Responsibilities Compile and submit registration dossiers and eCTD submission (ACTD / ASMF / CDMF / CEP / JDMF / KDMF / USDMF / TD Brazil/ Technical Package) to the international health authorities and customers. Prepare LOA (DMF) / LOE / LOC & other declarations as per customer's requirement & handle queries received from Bulk Drug...