Manager- Drug Regulatory Affairs

17 hours ago

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

Company Description

Lezivia 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 Description

This is a full-time, on-site role located in Ahmedabad for a Manager of Drug Regulatory Affairs specializing in Pharma Oral Solid Dosage (OSD) forms. The role involves managing regulatory compliance, preparing and submitting regulatory documents, and ensuring adherence to regulatory requirements. The Manager will work closely with quality assurance teams to maintain the quality systems and will be responsible for keeping up-to-date with changes in regulatory affairs to ensure ongoing compliance.

Qualifications

  • Strong understanding of Regulatory Compliance, Regulatory Requirements, and Regulatory Affairs
  • Experience in Regulatory Submissions
  • Knowledge of Quality Systems
  • Excellent analytical and organizational skills
  • Bachelor's degree in Pharmacy, Chemistry, Biology, or a related field
  • Prior experience in the pharmaceutical industry, particularly with Oral Solid Dosage forms, is preferred
  • Ability to work on-site in Ahmedabad
  • Strong communication and interpersonal skills

  • 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...

  • Regulatory Affairs Specialist

    2 weeks ago

    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...

  • Regulatory Affairs Specialist

    1 week ago

    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...

  • Senior Regulatory Affairs Officer

    2 weeks ago

    Ahmedabad, Gujarat, India Lifelancer Full time

    Job Title Senior Regulatory Affairs OfficerJob Location Ahmedabad Gujarat IndiaJob Location Type On-siteJob Contract Type Full-timeJob Seniority Level AssociateSkills Regulatory Affairs Quality Assurance Regulatory Strategy Development Class III Medical Devices Product Registration international legislation accreditation requirements ...

  • Regulatory Affairs Officer

    5 days 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 Specialist

    2 weeks ago

    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...

  • Regulatory Affairs Specialist

    2 weeks ago

    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...

  • Regulatory Affairs Manager

    7 days ago

    Ahmedabad, Gujarat, India Red Envelope Consultants Full time

    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 for Rest of the World (RoW) markets, ensuring compliance with country-specific...

  • Regulatory Affairs Executive

    2 weeks ago

    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...

  • Regulatory Affairs Specialist

    1 week ago

    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:...