Sr. Regulatory Affairs

3 weeks ago

Ahmedabad, India EaseBiz FinTech Solutions LLP Full time

Job Description:

A Sr. Regulatory Affairs professional in a Healthcare Pvt. Ltd. is responsible for the preparation, review, and submission of CTD/ACTD/eCTD dossiers, WHO-GMP, ICH, and country-specific requirements for regions such as ROW, LATAM, SEA, Africa, and Pacific. The role involves mentoring junior Regulatory Affairs staff and implementing process improvements to ensure compliance with regulatory standards.

Responsibilities:
  • Prepare, review, and submit CTD/ACTD/eCTD dossiers.
  • Ensure compliance with WHO-GMP, ICH, and country-specific regulatory requirements.
  • Manage regulatory submissions for regions including ROW, LATAM, SEA, Africa, and Pacific.
  • Mentor junior Regulatory Affairs staff.
  • Implement process improvements to enhance regulatory compliance.
Qualifications:
  • Bachelor's or Master's degree in Pharmacy, Life Sciences, or related field.
  • Minimum of 5 years of experience in Regulatory Affairs within the healthcare industry.
  • Strong knowledge of regulatory guidelines and requirements for CTD/ACTD/eCTD submissions.
  • Experience in working with WHO-GMP, ICH, and country-specific regulations.
Skills:
  • Regulatory Affairs Compliance
  • CTD/ACTD/eCTD Submissions
  • WHO-GMP Knowledge
  • ICH Guidelines
  • Process Improvement
  • Mentoring and Training
. Skillset Required: CTD/ACTD/eCTD, WHO-GMP, ICH, ICH Guidelines, Mentoring , Training

  • Senior Regulatory Affairs Specialist

    7 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

    3 days 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...

  • Regulatory Affairs Executive

    2 weeks ago

    Ahmedabad, India Prime Placement Full time

    Position: Regulatory Affairs Assistant - Cosmetic Industry Department: Regulatory Affairs Experience Required: 0-2 years Location: Santej, Ahmedabad Salary Range: 2.2 LPA - 3 LPA Roles & Responsibilities: 1. Handling Legal Documents and Regulatory Affairs: - Assist in the preparation, review, and submission of regulatory documents. - Maintain and...

  • 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...

  • 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

    1 day 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...

  • Regulatory affairs specialist

    2 weeks ago

    Ahmedabad, 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 ...

  • Regulatory Affairs Specialist

    2 weeks ago

    Ahmedabad, 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 seeking a...

  • Regulatory Affairs Specialist

    2 weeks ago

    Ahmedabad, India Frisch Medical Devices PVT LTD Full time

    Job Title: Regulatory Affairs Junior ManagerLocation: At Ahmedabad Office , Near Thaltej CrossroadsDepartment: RAReports To: RA Head and Regulatory Department at HO /DirectorEmployment Type: Full TimeOffice hours : 9,30 AM to 6 PMWeek of: Sunday and Saturday Half DayPreferred Gender : M/FExperience : Minimum 2 yearsJob Summary:We are seeking a proactive and...

  • Regulatory Affairs Executive

    3 days 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...