Regulatory Affairs

| 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.