Job Description

Job Title:

FDA Specialist

Department:

Regulatory Affairs / Quality Assurance

Job Summary:

We are seeking a detail-oriented FDA Specialist with 2 years of experience to ensure compliance with regulatory requirements and standards. The role involves coordinating with internal teams and external regulatory authorities to maintain adherence to FDA regulations, manage documentation, and assist in product approvals.

Key Responsibilities:

• Regulatory Compliance:
• Ensure all products comply with FDA guidelines and regulations.
• Stay updated on changes in FDA policies and advise the team accordingly.
• Documentation and Filing:
• Prepare, review, and submit regulatory documentation (e.g., 510(k), ANDA, IND, or other submissions).
• Maintain accurate records of regulatory submissions and approvals.
• Quality Assurance:
• Collaborate with the Quality team to ensure compliance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
• Conduct internal audits and inspections to ensure compliance with FDA standards.
• Communication and Coordination:
• Act as a liaison between the company and FDA regulatory bodies.
• Coordinate with cross-functional teams (e.g., R&D, production, and quality assurance) to ensure timely submissions and compliance.
• Risk Management:
• Identify potential compliance risks and develop strategies to mitigate them.
• Provide training and guidance to internal teams on FDA requirements and processes.
• Support Product Approvals:
• Assist in obtaining FDA approvals for new products and changes to existing products.
• Monitor post-market surveillance and compliance reporting.

Qualifications:

• Education:
• Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or related field.
• Experience:
• Minimum of 2 years of experience in FDA regulatory affairs or quality assurance.
• Skills:
• Strong knowledge of FDA regulations and guidelines (e.g., CFR, GMP, GLP).
• Excellent written and verbal communication skills.
• Proficiency in Microsoft Office and regulatory software.
• Ability to manage multiple projects and meet deadlines.
• Certifications (preferred):
• RAC (Regulatory Affairs Certification) or other relevant certifications.

Soft Skills:

• Strong attention to detail.
• Analytical and problem-solving abilities.
• Effective collaboration and teamwork.
• Ability to work independently and in a dynamic environment.

Job Type: Full-time

Pay: ?10,247.91 - ?44,321.13 per month

Benefits:

• Health insurance
• Provident Fund

Schedule:

• Day shift

Education:

• Bachelor's (Preferred)

Work Location: In person