Regulatory Affairs
About the job
**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 Responsibilities
As 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.
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### 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.
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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.
