Executive, Regulatory Affairs

2 weeks ago


Ahmedabad, Gujarat, India Avantika Medex Full time ₹ 15,00,000 - ₹ 28,00,000 per year

Role & responsibilities

Dossier Preparation in CTD/ACTD/Country Specific Formats

  1. Re-registration and Renewal Application

  2. Variation Application

  3. Queries Handling

  4. DMF Activity

  5. Artwork Review (Carton/Foil/Label/Insert/Shipper)

  6. Pack Insert Preparation as per Country Guideline

  7. Documents and Sample Collection Activity from F&D, QA, QC and Store department for registration requirement.

  8. Documents Review Knowledge: Pharmaceutical Development Report, Process Validation Protocol & Report, Excipients Specifications/MOA, Finished Product Specification/MOA, Packing Material Specification/MOA, COA, Stability Study Protocol & Report, MFR, BMR, BPR, Clinical/Non Clinical Literature Search Strategy, AMV, CDP, BE Study.

Experience Required: CDSCO, USFDA, EUGMP, NAFDAC

Dosage Form Experience Required:

Tablets, Capsules, Oral Powder (Sachet), External Preparation (Gel & Cream), Injections, Infusions, Suspension, Syrup, Oral Drops, Suppositories.



  • Ahmedabad, Gujarat, India Prompt Career Consultants Full time ₹ 15,00,000 - ₹ 28,00,000 per year

    Prepare, submit regulatory dossiers for new product registrationsCoordinate and manage the submission of regulatory documents Facilitate communication with health authorities, responding to queries Required Candidate profileM. Pharm (Female Candidate Preferred)1 year of experience in Regulatory Affairs in Pharmaceutical Formulations unit desired.Excellent...


  • Ahmedabad, Gujarat, India beBeeRegulatory Full time ₹ 9,00,000 - ₹ 12,00,000

    About Regulatory AffairsRegulatory Affairs professionals play a vital role in ensuring the timely and successful submission of high-quality regulatory labeling submissions. They work closely with cross-functional teams, including Compliance, Marketing, R&D, engineering (packaging), manufacturing, and QA/QC.Main Responsibilities:Ensure the on-time filing of...


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

    Job Title: Regulatory Affairs Junior Manager Location: At Ahmedabad Office , Near Thaltej Crossroads Department: RA Reports To: RA Head and Regulatory Department at HO /Director Employment Type: Full Time Office hours : 9,30 AM to 6 PM Week of: Sunday and Saturday Half Day Preferred Gender : M/F Experience : Minimum 2 years Job Summary: We are...


  • Ahmedabad, Gujarat, India 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...


  • 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

    2 weeks ago


    Ahmedabad, Gujarat, India Sunrise Remedies Full time ₹ 15,00,000 - ₹ 28,00,000 per year

    Sunrise Remedies Job Opening for Regulatory Affairs (RA) officer.Experience: 1 YearIndustries: Pharmaceutical CompanyEducation: B.Sc. | M.Sc | B.Pharm | M.PharmJob Location: Santej Ahmedabad.Facilities Provided:– Transportation Facility Available (As Per Circumference Of Sunrise Remedies)*– Mediclaim and Food Facility provide By Company.*Key...


  • Ahmedabad, Gujarat, India beBeeRegulatoryAffairs Full time ₹ 15,00,000 - ₹ 28,00,000

    Regulatory Affairs RoleObjectiveWe are seeking a highly skilled Regulatory Affairs professional to join our team. The successful candidate will be responsible for preparing, reviewing and maintaining regulatory documents to ensure compliance with international guidelines and country-specific requirements.Required Skills and...


  • Ahmedabad, Gujarat, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 28,00,000

    Regulatory Affairs SpecialistWe are seeking a seasoned Regulatory Affairs Specialist to join our team. As a key member of the regulatory department, you will be responsible for ensuring compliance with regulatory requirements and facilitating smooth market access.About This RoleThis role is ideal for an experienced professional with 10-15 years in Regulatory...


  • 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,...


  • Ahmedabad, Gujarat, India beBeePharmacovigilance Full time ₹ 15,00,000 - ₹ 28,00,000

    Job Title: Regulatory Affairs Specialist - PharmacovigilanceAbout the RoleThis is an exciting opportunity to join our team as a Regulatory Affairs Specialist - Pharmacovigilance, where you will be responsible for ensuring compliance with regulatory requirements and coordinating submissions to relevant authorities.Key ResponsibilitiesPSUR and ACO Scheduling:...