Regulatory Affairs

**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.| Position | Regulatory Affairs Executive || **Experience** | 6 months to 1 year || **Location** | Ahmedabad, Gujarat || **Qualification** | B.Pharm/M.Pharm | Key ResponsibilitiesAs a Regulatory Affairs Executive, you will primarily be responsible for supporting the regulatory filing process and maintaining product compliance in various international markets, with a focus on emerging 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.***### Required Qualifications and Skills* **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.*** Why Vivanza Biosciences Limited?Join a growing pharmaceutical company dedicated to providing high-quality, affordable medicines globally. At Vivanza Biosciences, you will have the opportunity to:* 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.