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Regulatory Affairs Associate
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Regulatory Affairs Associate
Ahmedabad
Gandhinagar
Full-Time
Mid-Level: 5 to 7 years
Posted on Jul 22 2024
Not Accepting Applications
About the Job
Skills
Knowledge of regulatory requirements
FDA
Attention to detail
Strong communication skills
Project management
Ability to work under pressure
Research skills
Job Summary:
The Regulatory Affairs Specialist is responsible for ensuring that the company’s pharmaceutical products comply with all regulatory requirements set forth by the FDA and other relevant health authorities. This role involves preparing and submitting regulatory documents, maintaining up-to-date knowledge of regulatory guidelines, and collaborating with cross-functional teams to facilitate product development and commercialization.
Key Responsibilities:
- Regulatory Submissions:
- Prepare and submit regulatory submissions to the FDA and other regulatory bodies, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), Biologics License Applications (BLAs), and New Drug Submissions (NDS).
- Ensure all submissions are complete, accurate, and in compliance with regulatory requirements.
- Regulatory Strategy and Planning:
- Develop and implement regulatory strategies to support product development and approval.
- Provide regulatory guidance and support to cross-functional teams, including R&D, clinical, quality, and marketing.
- Regulatory Research and Analysis:
- Stay current with FDA regulations, guidelines, and policies, as well as international regulatory requirements.
- Conduct regulatory research to identify changes in regulations and their potential impact on product development and commercialization.
- Liaison and Communication:
- Act as the primary point of contact with regulatory agencies, including the FDA, and manage communications related to regulatory submissions and compliance.
- Coordinate with external consultants, contractors, and CROs to support regulatory activities.
- Compliance and Documentation:
- Ensure that all regulatory activities and documentation are maintained in accordance with FDA regulations and company policies.
- Prepare and maintain regulatory files, including electronic submissions (eCTD) and documentation required for regulatory inspections and audits.
- Project Management:
- Manage multiple regulatory projects simultaneously, ensuring timely and efficient submission of regulatory documents.
- Track and report on the status of regulatory submissions and provide updates to management and relevant stakeholders.
- Quality and Continuous Improvement:
- Contribute to the development and implementation of quality systems and processes to enhance regulatory compliance and efficiency.
- Participate in internal and external audits, inspections, and meetings with regulatory agencies.
Qualifications:
- Bachelor’s degree in Pharmacy, Life Sciences, Biology, Chemistry, or a related field. Advanced degree preferred.
- Minimum of 5 years of experience in regulatory affairs within the pharmaceutical industry.
- Strong knowledge of FDA regulations, guidelines, and submission requirements.
- Experience with electronic submission systems (eCTD, eSubmitter).
- Excellent organizational, analytical, and problem-solving skills.
- Strong communication and interpersonal skills, with the ability to work effectively across departments and with external partners.
Preferred Qualifications:
- Certification in Regulatory Affairs (e.g., RAC).
- Experience with global regulatory submissions and international health authorities.
- Proven track record of successful regulatory submissions and product approvals.
About the company
We Ensure all product to meet our High Qwest-Coast Pharmaceuticals Works Limited is a global pharmaceutical company. It manufactures Pharmaceutical finished formulations, Dietary Supplements & Cosmeceutical Products. The company offers pharmaceuticals in a wide range of dosage forms, including capsules, tablets, ointments, liquids & creams. Plant is approved by WHO-GMP, NAFDAC-Nigeria, PPB Kenya & ...Show More
We Ensure all product to meet our High Qwest-Coast Pharmaceuticals Works Limited is a global pharmaceutical company. It manufactures Pharmaceutical finished formulations, Dietary Supplements & Cosmeceutical Products. The company offers pharmaceuticals in a wide range of dosage forms, including capsules, tablets, ointments, liquids & creams. Plant is approved by WHO-GMP, NAFDAC-Nigeria, PPB Kenya & MOH-Zambia.
We also Manufacturer Disinfectant Products. (All hospital disinfectant products), Medicated Soaps, Food Supplements/ Nutraceuticals products, Veterinary products, Sustained release drugs, Ready Premix, Herbal Products, OTC category products.uality Economical and Delivery Standards. ...Show Less
Industry
Pharmaceuticals
Company Size
501-1000 Employees
Headquarter
Ahmedabad, Gujarat
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