REGULATORY AFFAIRS

The Regulatory Affairs Specialist ensures pharmaceutical products comply with all relevant regulations. Responsibilities include preparing and submitting regulatory documents, maintaining compliance with laws, and communicating with regulatory agencies. The role supports product registration and quality assurance while staying updated on regulatory changes.

Job Summary:

The Regulatory Affairs Specialist in a pharmacy setting ensures that all pharmaceutical products comply with federal, state, and local regulations. This role involves preparing and submitting regulatory documents, monitoring changes in regulations, and maintaining compliance to facilitate the smooth operation of the pharmacy’s drug products.

Key Responsibilities:

  • Regulatory Compliance:
    • Ensure all pharmaceutical products meet regulatory requirements and standards.
    • Prepare and submit regulatory filings, including drug applications, amendments, and renewals.
  • Documentation and Reporting:
    • Maintain accurate and up-to-date records for regulatory submissions and approvals.
    • Compile and review documentation required for audits and inspections.
  • Regulatory Monitoring:
    • Monitor and interpret changes in laws and regulations affecting pharmaceutical practices.
    • Advise on regulatory implications of new products, changes in formulations, and manufacturing processes.
  • Coordination and Communication:
    • Liaise with regulatory agencies to address queries and resolve issues.
    • Work closely with internal teams (e.g., R&D, quality assurance) to ensure compliance throughout the product lifecycle.
  • Quality Assurance:
    • Support quality assurance efforts to ensure that products meet all regulatory and safety standards.
    • Assist in the development and implementation of compliance procedures and policies.

Qualifications:

  • Education: Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, or a related field. Advanced degree or certification in regulatory affairs is a plus.
  • Experience: [X] years of experience in regulatory affairs within the pharmaceutical industry or a related field.
  • Skills:
    • Strong understanding of regulatory requirements and guidelines.
    • Excellent written and verbal communication skills.
    • Detail-oriented with strong organizational and analytical abilities.
    • Ability to manage multiple projects and deadlines effectively.

Working Conditions:

  • Hours: Full-time position, with standard office hours and occasional extended hours as needed.
  • Environment: Office setting, with potential for occasional travel to regulatory agency meetings or inspections.