
Regulatory Affairs Officer
4 weeks ago
We 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, Compilation of the CTD/ACTD dossiers for the ROW market.
2. Ensuring that quality standards are met and submissions meet within stipulated timelines.
3. Prepare accurate and timely responses to queries received from regulatory agencies.
4. Ensure that all product artwork is updated and submitted in correct format
5. Communicate and follow up with the agent for progress of registration submission.
6. Maintain record for the Dossier and sample submission.
7. Coordinate with other departments for for relevant documents required for dossier.
8. To review all the documents for accuracy as per ICH or Country specific requirement.
9. Responsible for Compilation & Review of Quality documents like RM/FP, STP, Stability Protocols & Report, Process Validation protocols & reports, Analytical method validations.
10. Arranging samples, working standard, artwork as per country requirement and submitting them to the Regulatory authority within a specified time frame.
11. Maintaining & updating country wise registration status and arranging for renewal.
12. Should have experience in Pharma Formulation Company
Please send updated CV + Current CC and Notice Period
Pooja Nair
Schedule:
- Day shift
Work Location: In person
-
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...
-
Regulatory Affairs Officer
2 weeks 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...
-
Officer - Regulatory Affairs
4 weeks ago
Mumbai, India TheTalentforte.com Full time**Require**:REGULATORY AFAIRS EXECUTIVE/OFFICER **Experience**:Min.2 years experience in Pharma Formulations Regulatory Affairs. Schedule: - Day shift **Speak with the employer** +91 8097337489
-
Regulatory Affairs Officer
2 weeks ago
Mira Road, Mumbai, Maharashtra, India Vimek Bioconcept Pvt LTd Full timeA regulatory affairs (RA) professional in the in vitro diagnostics (IVD) industry typically has responsibilities that include: - **Developing regulatory strategies**: Creating and implementing global regulatory strategies for IVD products - **Reviewing submissions**: Reviewing and revising submissions to regulatory agencies - **Managing change control**:...
-
Compliance Officer
7 hours ago
Mumbai, Maharashtra, India Colgate-Palmolive Full timeJoin us as a Compliance Officer - Regulatory Affairs and play a key role in ensuring the quality and safety of our products.As a Compliance Officer - Regulatory Affairs, you will be responsible for managing and maintaining product compliance during the whole life-cycle for any category of products. You will work closely with the Regional Regulatory Affairs...
-
Regulatory Affairs Executive
2 weeks 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 Officer
3 weeks ago
Wagholi, Pune, Maharashtra, India Statistical Pharma Full time**Regulatory Affairs Officer Duties & Responsibilities** The role and function of a Regulatory Affairs Officer includes the following duties and responsibilities: - Preparing submissions of licence variations and renewals to strict deadlines; - Ensuring that a company’s products comply with regulations; - Keeping abreast of international legislation,...
-
Regulatory Affairs Officer
4 weeks ago
Mumbai, Maharashtra, India MEDVARSITY ONLINE LIMITED Full timeJob Title: Senior Executive - Regulatory Affairs UK/IE/MT Department: Regulatory Affairs Grade Level: P-2 Reports to: Manager / Sr. Manager - Regulatory Affairs Number of Reports: NONE Location: Mumbai **Main purpose of role**: To ensure adequate and prompt life cycle maintenance activities for Marketing Authorization’s (MA) held based on portfolio...
-
Regulatory Affairs Executive
4 weeks ago
Pune, 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, organising,...
-
Regulatory Affairs Executive
3 weeks ago
Mumbai, Maharashtra, India Clini launch Business Solutions Full timeWe are seeking a knowledgeable and experienced Regulatory Affairs Specialist with expertise in the Drugs & Cosmetics Act and FSSAI regulations, as well as experience in FDA-related activities. This role is essential for ensuring robust functional and cross-functional coordination (R&D, QC, Marketing, Legal, Production, etc.) and for the transparent execution...
-
Mumbai, Maharashtra, India Aurashine Essentials Private Limited Full time**Position: Regulatory Affairs Specialist - Fragrance & Flavours Location: Andheri East,** Mumbai Type: Full time Package: 7.0 L Key Responsibilities: Regulatory Expertise: - Possess a comprehensive understanding of international and national regulations specific to the fragrance and flavour industry, including FDA, FSSAI, SEDEX, BRC, ISO 9001:2015, ISO...
-
Team Member
3 weeks ago
Vikhroli, Mumbai, Maharashtra, India Cipla Full time**Division**: - Corporate Affairs **Department**: - Corporate **Sub Department 1**: **Job Purpose**: - Coordination for dossier checklist, preparation and submission, follow-up for timely regulatory approval and response submission. - Participate in discussions and coordinate with RA/IPD/Portfolio/Medical Affairs/Marketing team to obtain all the...
-
Female - Urgent: Regulatory Affairs
4 weeks ago
Mumbai, Maharashtra, India Double HR Consultancy Full timeFemale - 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...
-
Regulatory Affairs Executive
2 weeks ago
Mumbai, India Morpheus Human Consulting Full timeReference 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...
-
Associate, Regulatory Affairs
4 weeks ago
Mumbai, Maharashtra, India Colgate-Palmolive Full timeRelocation Assistance Offered Within Country Job Number #163733 - Mumbai, Maharashtra, India **Who We Are** Colgate-Palmolive Company is a global consumer products company operating in over 200 countries specializing in Oral Care, Personal Care, Home Care, Skin Care, and Pet Nutrition. Our products are trusted in more households than any other brand in the...
-
Regulatory Affairs Expert
16 hours ago
Mumbai, Maharashtra, India Tata Consultancy Services Full timeAt Tata Consultancy Services, we are seeking an experienced Regulatory Affairs Specialist to join our team.Job DescriptionThe successful candidate will be responsible for ensuring compliance with regulatory requirements and guidelines in the pharmaceutical industry.The ideal candidate should have:A minimum of 5-8 years of experience in Regulatory Affairs...
-
Regulatory Affairs Manager
2 weeks ago
Mumbai, India Astellas Pharma Full timeAstellas Pharma India i s looking for a Regulatory Affairs (RA) Manager , based in Mumbai, India. Purpose and Scope: Planning, preparation and submission for Market Authorization, Registration of product, new indication, and maintenance of registration and its compliances. Interaction and coordination with DCGI(CDSCO) and SFDA and concerned regulatory bodies...
-
Regulatory Affairs Executive
3 weeks ago
Mumbai, Maharashtra, India TheTalentforte.com Full timeIf you are interested in this opportunity, please send your updated CV + Current CTC Manufacturer and 100% Exporter of Pharmaceutical Formulations **REGULATORY AFFAIRS EXECUTIVE** Job Location: Vikhroli West, Mumbai Work Timings: 2nd & 4th Sat Off, Timings: 9.30 TO 6 OR 10 TO 6.30 Salary Range: 4 to 5 Lacs PA, depending on experience B. Pharma / M....
-
Regulatory Affairs Specialist
15 hours ago
Mumbai, Maharashtra, India Colgate-Palmolive Full timeAt Colgate-Palmolive, we are committed to ensuring the quality and safety of our products. As a Regulatory Affairs Specialist, you will play a key role in managing product compliance during the whole life-cycle for any category of products.You will work closely with the Regional Regulatory Affairs Department to support the regulatory strategy defined at...
-
Regulatory Affairs Specialist
6 days ago
Mumbai, Maharashtra, India Lifelancer Full timeWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Lifelancer, a talent-hiring platform in Life Sciences, Pharma and IT.Job DescriptionThe Regulatory Affairs Specialist will be responsible for providing support for the regulatory department to ensure efficient and compliant business processes and environment. This includes...