Regulatory Affairs

3 weeks ago

Ahmedabad, India VITAL INTELLIGENCE TECHNOLOGY PRIVATE LIMITED Full time



**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.


***


### 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.

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