Regulatory Affairs

Skills:

• Vivanza Biosciences Limited** is seeking a highly motivated and detail-oriented professional to join our team as a **Regulatory Affairs Executive** in Ahmedabad, Gujarat. This role is ideal for an individual with foundational experience in the pharmaceutical industry who is keen to grow their career in regulatory compliance and submissions for global markets.
  

• **Documentation and Dossier Support:**
• Assist in the preparation and compilation of drug product dossiers, primarily in **ACTD/CTD formats**, for submission to regulatory authorities in African, LATAM, CIS Countries, and other emerging markets.
• Support the compilation of essential regulatory documents such as **Certificates of Analysis (COA)**, **Manufacturing Formula Records (MFR)**, **Process Validation (PV)**, and **Stability Data**.
• Ensure all documents are accurate, complete, and compliant with country-specific regulatory guidelines.
• **Cross-Functional Coordination:**
• Liaise and coordinate effectively with internal departments, including **Formulation & Development (F&D)**, **Quality Assurance (QA)**, **Quality Control (QC)**, and **Production**, to gather necessary technical and quality documentation.
• Coordinate with the Artwork department for review and approval of product labeling and packaging materials to ensure regulatory compliance.
• **Compliance and Maintenance:**
• Assist in the review of technical documentation (**CMC review**) for regulatory filings.
• Maintain and track records of regulatory submissions, approvals, and correspondences with health authorities.
• Support the team in responding to regulatory queries and deficiencies in a timely manner.
• **Regulatory Intelligence:**
• Conduct basic research on updated regulatory guidelines and requirements for target markets.
  

• **Education:** Bachelor of Pharmacy (**B.Pharm**) or Master of Pharmacy (**M.Pharm**) from a recognized university.
• **Experience:** 6 months to 1 year of hands-on experience in Regulatory Affairs within the pharmaceutical industry.
• **Technical Skills:**
• Basic knowledge of **CTD/ACTD** structure and regulatory documentation.
• Familiarity with regulatory requirements for international/emerging markets is a plus.
• Proficiency in **MS Office** (Word, Excel, PowerPoint) and electronic document management systems.
• **Soft Skills:**
• Excellent **attention to detail** and organizational skills.
• Strong written and verbal **communication skills**.
• Ability to work effectively in a team and coordinate with various departments.
• High degree of professionalism and a proactive approach to work.
  

• Gain hands-on experience in a critical function of the pharmaceutical industry.
• Work on regulatory submissions for a diverse portfolio and global markets.
• Grow your career in a dynamic and supportive environment.