Asst. Manager/Manager Regulatory Affairs

6 hours ago

Ahmedabad, Gujarat, India Sakar Healthcare Full time ₹ 15,00,000 - ₹ 25,00,000 per year

Sakar Healthcare Ltd incorporated in 2004 has emerged as a leading pharmaceutical manufacturer based in Western India, specialized with innovative oncology solutions.

With the research-driven API-integrated EU GMP approved oncology orals & injection formulation manufacturing units, Sakar is ready to cater the global markets with diverse product range and business models.

  • Mentor regulatory team of 12, conduct training sessions on the latest regulatory updates have experience of trouble shooting with good communication skills client handling.
  • Preparing/ checking and submitting technical files and compilation of dossiers in CTD format of Product life-cycle management in ROW & EU markets.
  • Ensuring Effective and Prompt Attention and Handling of Queries from MOH of various Countries and Handling product registration.
  • Review follow-up and co-ordination for registration samples /WS and impurities required for analysis purpose along with technical documents for dossier compilation.
  • Preparation of Data required for Artwork subsequent checking
  • Co-ordination for Bioequivalence Studies and Comparative Dissolution data as per requirement.
  • Coordinating with the Plants for Technical Inputs.
  • Preparation and checking of legal documents like applications to FDA for product permission, FSC, COPP, Health Certificates, DCGI permissions for formulations, neutral code, labeling, etc.
  • Monitor for changes in regulatory strategy at relevant agencies/authorities to identify potential impact to company s business segments from emerging regulatory issues.
  • Preparation, gap analysis of submission documents and authoring technical reports for cross functional teams. Ensure a high scientific standard and quality for all regulatory documents.
  • Manage proactive and professional delivery of results for the regulatory activities of all the products to support the business goals. Handle regulatory activities by setting and managing work priorities and time allocation.
  • Providing regulatory support for out-licensing projects

  • Regulatory Affairs

    2 hours ago

    Ahmedabad, Gujarat, India Medipharma Konnect Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    We are hiring Regulatory Affairs (RA) Executive / Manager for a leading Pharma company in Ahmedabad. The candidate will be responsible for dossier preparation, product registration, regulatory submissions, and maintaining compliance with international guidelines (ROW / LATAM / Africa). Must have hands-on experience in RA documentation for pharma...

  • Regulatory Affairs

    2 weeks ago

    Ahmedabad, Gujarat, India VITAL INTELLIGENCE TECHNOLOGY PRIVATE LIMITED Full time ₹ 30,00,000 - ₹ 60,00,000 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...

  • Asst Manager- Drug Regulatory Affairs- Pharma OSD/Soft Gelatin

    7 days ago

    Ahmedabad, Gujarat, India Lezivia Lifesciences Full time ₹ 8,00,000 - ₹ 12,00,000 per year

    Company DescriptionLezivia Lifesciences is a well-regarded company, known for its commitment to providing high-quality pharmaceutical products. Most of its products are manufactured at WHO-approved facilities, ensuring the best quality for patients. Lezivia values innovation and excellence in healthcare solutions.Role DescriptionThis is an on-site full-time...

  • Regulatory Affairs Executive

    2 weeks ago

    Ahmedabad, Gujarat, India Morgan Placement Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Seeking a Regulatory Affairs professional (5–12 yrs exp, US FDA focus) to manage product approvals, ensure compliance, and liaise with regulatory bodies. B.Pharm/M.Pharm required.

  • Regulatory Affairs Executive

    6 hours ago

    Ahmedabad, Gujarat, India nutralike formulation Pvt Ltd Full time ₹ 4,00,000 - ₹ 8,00,000 per year

    Nutralike is a leading nutraceutical manufacturer offering premium-quality products across tablets, capsules, powders, and syrups. With global compliance standards and presence across ROW, Middle East, EU, CIS, and GCC markets, Nutralike focuses on innovation, safety, and quality. Learn more at Job Summary:The Regulatory Affairs Executive will be...

  • Regulatory Affairs Executive

    1 week ago

    Ahmedabad, Gujarat, India Uniza Group Full time ₹ 6,00,000 - ₹ 12,00,000 per year

    Company DescriptionUniza is part of the $150 M+ Pashupati group of companies, specializing in India Business, International Business, and the manufacturing of tablets, capsules, creams, and ointments. With a strong distribution network across 28 states in India, Uniza has established a significant presence in Dermatology, Cardio-Diabetic, Gynecology, and...

  • Regulatory Affairs Associate

    1 week ago

    Ahmedabad, Gujarat, India Smart Lion Full time ₹ 4,00,000 - ₹ 12,00,000 per year

    Regulatory Affairs Associate Responsible for preparation, review & submission of regulatory documents (US FDA, EMA, ICH), ensuring compliance with guidelines, supporting product approvals, maintaining records & coordinating with authorities. Required Candidate profileBSC/MSC/B.Pharm or Life Sciences graduate with knowledge of regulatory guidelines, dossier...

  • Officer - Plant Regulatory Affair Department

    2 hours ago

    Ahmedabad, Gujarat, India Emcure Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Roles and ResponsibilitiesPrepare dossiers for US FDA, including CTD format.Ensure regulatory compliance with RA requirements.Manage parenteral products' dossier preparation and submission to regulatory authorities.Coordinate with cross-functional teams for injectable product development and registration.Track regulatory updates and maintain records in...

  • Regulatory Affairs Manager

    7 days ago

    Ahmedabad, Gujarat, India Zenith Health Science - FZCO Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Company DescriptionZenith Health Science - FZCO (ZHS) is a hybrid B2B pharmaceutical venture created by industry veterans with over 25 years of experience. The company's specialty lies in launching complex generic products that face low competition in the market.Job descriptionTo develop and manage all global regulatory strategies, oversee the preparation...

  • Senior Regulatory Affairs Executive

    4 days 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...