Regulatory Affairs

**Company Description** Briyosis Soft Caps Pvt. Ltd. is a privately-owned contract manufacturer of custom dietary supplement formulations. Based in Vadodara, India, we are an FDA registered and WHO-GMP certified company. With our high-efficiency encapsulation lines operating 24/7, we have the capability to produce over 3 billion soft-gels annually. Our...

Regulatory Affairs Specialist - Global Regulatory ExpertResponsible for handling global regulatory submissions, ensuring compliance with health authorities and regulations.Conduct dossier gap analysis to identify document and data gaps across all CTD modules (1–5).Prepare and submit regulatory dossiers in multiple formats including eCTD, ACTD, and...

As a Junior Regulatory Affairs Executive, you will have the opportunity to work with a dynamic team of professionals in the field of regulatory affairs.Key ResponsibilitiesConducting technical writing tasks to prepare necessary documentation for regulatory submissionsCollaborating with manufacturers of medical and diagnostic devices in product design,...

**POST**:RA OFFICER/EXECUITVE **LOCATION: JAROD, VADODARA** **EXPERIENCE**: 2-3 YEARS Experience in handling regulatory affairs for ROW market mainly Latin American, African & Asian countries for Pharma Formulations. Preparation, compilation & Review of Registration documents that include Administrative & Technical. Reviewing the technical documents...

Position SummaryThe Regulatory Affairs Manager is responsible for leading regulatory strategy, planning, documentation, and submissions for medical device products across global markets, including the EU (EU MDR), United States (FDA), India (CDSCO), and other applicable regions. This role ensures compliance with all regulatory requirements throughout...

1. Preparation, Review and Submission of the Dossiers as per CTD/ACTD guidelines as well a country specific guidelines. 2. Compilation of Dossiers and quality documents as per checklist in the guidelines. 3. Review of artworks as per the Regulatory requirements 4. Inter Department coordination to arrange and review of documents and samples for Regulatory...

Key Responsibilities: 1. Develop the global regulatory strategies for biologic products across all development phases (preclinical to post-marketing) for the (US, EU, and ROW). 2. Ensure alignment with business goals and regulatory requirements across the different regions. (FDA, EMA, emerging markets). 3. Prepare, review, and manage high-quality regulatory...

Company DescriptionBriyosis Soft Caps Pvt. Ltd. is a privately-owned contract manufacturer of custom dietary supplement formulations. Based in Vadodara, India, we are an FDA registered and WHO-GMP certified company. With our high-efficiency encapsulation lines operating 24/7, we have the capability to produce over 3 billion soft-gels annually. Our 100,000...

**Vega Biotec Pvt Ltd** a part of Vega group of companies having global presence and state of the art manufacturing pharmaceutical factory is having an opening for the following post. Qualification - B.Pharm/ M. Pharm Experience - 3+ years of experience in regulatory affairs for ROW market (Rest of the world) **Job Summary**: The Regulatory Affairs...

**Vega Biotec Pvt Ltd** a part of Vega group of companies having global presence and state of the art manufacturing pharmaceutical factory is having an opening for the following post. Qualification - B.Pharm/ M. Pharm Experience - 3+ years of experience in regulatory affairs for ROW market (Rest of the world) **Job Summary**: The Regulatory Affairs...