Regulatory Affairs- Nutraceuticals,vitamins

3 days ago

Mumbai, India Jayant Specialities Pvt. Ltd. Full time

**Preferred from Nutraceuticals Background**

**Preferred from Western Line of Mumbai**

**RESPONSIBILITIES & ACCOUNTABILITIES**
- Principle accountabilities are assisting in Regulatory Fillings.
- This involves, manageable knowledge on the regulatory and quality guidelines from various regulatory agencies FASSI (Nutraceuticals) ,ICH, FDA, EMA, Health Canada, ANVISA, PMDA, MFDS, CFDA etc.
- Strong knowledge on compilation of dossier and regulatory filling for ROW market, Japan, Europe and US/Canada as per requirement.
- Should have hands on experience on eCTD regulatory submission tools.
- Filling of regular amendments and annual updates to regulatory agencies. And complete life cycle management of existing filled products.
- Handling customer and regulatory queries as per requirement.
- Participation in the cross functional team meetings and providing regulatory inputs to the Product Development Teams.
- Liaisoning with various Govt. bodies and overseas partners for external interface and with Plant, RD, QC and Business Development for internal interface.
- Identifying the product quality issues, investigating the root causes and providing the technical solutions for compliance.
- Help in investigating regulatory complaints, customer market complaints, incidents, deviations, OOS, recalls and stability.
- Developing new procedures for various departments for strict compliance to GMP standards.
- Strong Knowledge on cGMP and ICH Guidelines.
- Representing during various regularity inspections (Local FDA, CDSCO, WHO, etc.).

**REQUIRED KNOWLEDGE AND EXPERIENCE (Job Specification)**:
**Education**: B. Pharm / M. Pharm

**Additional**: Diploma in Regulatory Affairs is preferred

**Experience**: 4yrs to 10 Yrs of experience in Regulatory Affairs

**IT Skills**: Should be familiar MS Office (Word, Excel & Power Point)

**Salary**: ₹360,000.00 - ₹500,000.00 per year

Schedule:

- Fixed shift

**Speak with the employer**
+91 7506726060

  • Regulatory Affairs Specialist

    2 days ago

    Mumbai, Maharashtra, India beBeeRegulatoryAffairs Full time ₹ 9,00,000 - ₹ 12,00,000

    Regulatory Affairs Manager Job DescriptionThe role involves developing and executing regulatory strategies, compiling and reviewing regulatory submissions, ensuring product compliance and acting as a key liaison with regulatory agencies.Key Responsibilities:Submission Management: Preparation, review and submission of regulatory documentation (e.g., dossiers,...

  • Executive-Vitamins & Additives

    3 weeks ago

    Mumbai, Maharashtra, India Godrej Industries Group Full time

    Job DescriptionAbout Godrej AgrovetGodrej Agrovet Limited (GAVL) is a diversified, Research & Development focused agri-business Company dedicated to improving the productivity of Indian farmers by innovating products and services that sustainably increase crop and livestock yields. GAVL holds leading market positions in the different businesses it operates -...

  • Manager- Regulatory Affairs

    2 weeks ago

    Mumbai, Maharashtra, India Piramal Enterprises Full time

    Job DescriptionJob Description :Business: Piramal Critical CareDepartment: Regulatory AffairsLocation: KurlaTravel: LowJob OverviewThe Manager, Regulatory Affairs is responsible for the portfolio of Piramal Critical Care Products in the USA market. They will be responsible for authoring and reviewing submissions for dissemination to Health Authorities,...

  • Regulatory Affairs Executive

    3 days ago

    Mumbai, 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 Executive

    3 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 Professional

    5 days ago

    Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 2,20,00,000 - ₹ 2,54,00,000

    Regulatory Affairs LeaderSr Manager Regulatory Affairs responsible for developing and executing regulatory strategies, compiling and reviewing regulatory submissions, ensuring product compliance, and acting as a key liaison with regulatory agencies.Key Responsibilities:Submission Management:Preparing, reviewing, and submitting regulatory documentation to...

  • Regulatory Affairs Specialist

    1 day ago

    Mumbai, Maharashtra, India beBeeCompliance Full time ₹ 12,00,000 - ₹ 18,00,000

    Regulatory affairs specialists play a vital role in ensuring compliance with regulatory requirements and facilitating the smooth operation of businesses.This position requires an individual with expertise in regulatory affairs, including experience with eCTD software and e-publishing requirements throughout the project lifecycle. The ideal candidate will...

  • Regulatory Affairs Professional

    7 days ago

    Mumbai, Maharashtra, India beBeeSpecialist Full time US$ 40,000 - US$ 80,000

    Regulatory Affairs SpecialistThe role involves the compilation, submission and management of regulatory documentation for assigned projects.Responsibilities include maintaining accurate database records pertaining to products, in line with established systems and processes.Supporting and coordinating regulatory affairs projects, as assigned, including tender...

  • Regulatory Affairs Officer

    3 days ago

    Mumbai, India TheTalentforte.com Full time

    **REGULATORY AFFAIRS EXECUTIVE** Job Location: VIkhroli Mumbai Qualification: B.Pharma / M.Pharma OR MSc + Diploma in Drug Regulatory Affairs Experience: 3 to 4 years in Regulatory Affairs of Pharma Formulations **JOB PROFILE** 1. Preparation and submission of registration dossier in CTD/ACTD /country specific format for countries in CIS, Africa, South...

  • Regulatory Affairs Executive/pharmaceutical

    3 days ago

    Mumbai, India Double HR Consultancy Full time

    Mumbai, Vile Parle, Dombivli East Regulatory Affairs Executive 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 the same industry. **Job Description**: - Managing regulatory...