Regulatory Affairs

1 day ago

Ahmedabad, Gujarat, India VITAL INTELLIGENCE TECHNOLOGY PRIVATE LIMITED Full time ₹ 2,50,000 - ₹ 7,50,000 per year

**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.

  • Regulatory Affairs Officer

    2 weeks ago

    Ahmedabad, Gujarat, India CLAPS Industries Private Limited Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Company DescriptionCLAPS Industries Pvt Ltd. is a global pharmaceutical company founded by a team of visionary and successful individuals in the pharmaceuticals field. With a focus on delivering top-quality healthcare products and services worldwide, CLAPS is rapidly growing through product diversification, strategic manufacturing expansions, and strong...

  • Regulatory Affairs Executive

    1 day ago

    Ahmedabad, Gujarat, India Vital Group Full time ₹ 12,000 - ₹ 14,90,645 per year

    Job Opening: Regulatory Affairs Executive | Vital GroupLocation: SG Highway, AhmedabadExperience: 1–3 years (Pharma Industry)Key Responsibilities:Preparation and submission of dossiers, CTD/ACTD, and regulatory documents.Handling regulatory queries and compliance requirements.Coordination with internal teams to ensure timely submissions.Support in product...

  • International regulatory Affairs

    1 week ago

    Ahmedabad, Gujarat, India CLAPS Industries Private Limited Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Company DescriptionCLAPS Industries Pvt Ltd. is a global pharmaceutical company that was founded by a visionary team of highly successful individuals in the field of pharmaceuticals. The company is dedicated to providing high-quality healthcare products and services globally. CLAPS is expanding rapidly through product diversification, strategic...

  • Manager- Drug Regulatory Affairs

    7 days ago

    Ahmedabad, Gujarat, India Lezivia Lifesciences Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    Company DescriptionLezivia Lifesciences is a reputed company known for its quality pharmaceutical products. Most of our products are manufactured at WHO-approved facilities, ensuring the highest quality standards for patient care. We are dedicated to delivering the best products to improve patient outcomes and well-being.Role DescriptionThis is a full-time,...

  • Senior Regulatory Affairs Specialist

    5 days ago

    Ahmedabad, Gujarat, India Jain Soap & Jain Lifecare Pvt Ltd Full time ₹ 32,00,000 - ₹ 48,00,000 per year

    Job Title:Sr. Regulatory ExecutiveLocation:Vadsar, GandhinagarCTC:₹4.0 LPA – ₹6 LPAExperience Required:2–4 years in Regulatory Affairs (Pharma or Cosmetics)Educational Qualification:B.Pharm / M.Pharm – Drug Regulatory Affairs, Quality Assurance, Pharmacology, or Pharmaceutical AnalysisRoles & Responsibilities:Prepare and review dossiers in...

  • Regulatory Affairs Specialist

    2 weeks ago

    Ahmedabad, Gujarat, India, Gujarat Frisch Medical Devices PVT LTD Full time

    Job Title: Regulatory Affairs Junior ManagerLocation: At Ahmedabad Office , Near Thaltej Crossroads Department: RA Reports To: RA Head and Regulatory Department at HO /Director Employment Type: Full TimeOffice hours : 9,30 AM to 6 PMWeek of: Sunday and Saturday Half Day Preferred Gender : M/FExperience: Minimum 2 years Job Summary:We are seeking a...

  • Regulatory Affairs Manager

    5 days ago

    Ahmedabad, Gujarat, India Red Envelope Consultants Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    Job Title: Senior Regulatory Manager – RoW MarketDepartment: Regulatory AffairsJob Summary:The Senior Regulatory Manager will be responsible for the preparation, review, and submission of high-quality regulatory dossiers and documents for pharmaceutical products intended forRest of the World (RoW) markets, ensuring compliance with country-specific...

  • Senior Regulatory Affairs Executive

    2 weeks ago

    Ahmedabad, Gujarat, India Synerxia Healthcare Full time ₹ 5,00,000 - ₹ 12,00,000 per year

    Job descriptionSYNERXIA Healthcare Pvt Ltd is engaged into Manufacturing & Exports of Nutraceuticals-Health/Dietary Supplements along with Pharmaceutical Products, is one of the Upstart organization is looking for position in Regulatory Affairs - Emerging / ROW Market for pre-submission and post-submission.Role and responsibilities Responsible for...

  • Deputy Regulatory Affairs Manager

    1 week ago

    Ahmedabad, Gujarat, India Opes Healthcare Full time ₹ 4,00,000 - ₹ 12,00,000 per year

    Role & responsibilitiesTo lead Regulatory affairs team engaged in dossier preparation in CTD and ACTD formats.Responsible for final review of dossier before submission.Reviewing artwork for products as per relevant regulatory authority requirements.Coordination with F&D, QA, QC & Store for documentationIn-depth knowledge of pharmaceutical documentation &...

  • AGM-GRA (Regulatory Affairs)

    3 days ago

    Ahmedabad, Gujarat, India Kashiv BioSciences LLC. Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    :Lead/support emerging markets (and Japan, Canada, ANZ) filing for Biosimilars, NCEs &ANDAs,Query responses, audit support, and lifecycle management.Regulatory support for the filing of IND/CTA to various regulatory agencies.Maintenance of IND/CTA through submission of protocol amendments, addition of investigators, EC approvals, SAE report submission,...