Regulatory Affairs Specialist

Regulatory Affairs Specialist

We are seeking a detail-oriented and knowledgeable Regulatory Affairs Specialist to join our pharmaceutical company. The successful candidate will play a crucial role in ensuring our products meet all regulatory requirements and in facilitating their approval and market access.

Responsibilities:

Regulatory Compliance

• Ensure compliance with all relevant regulatory requirements for pharmaceutical products
• Stay up-to-date with changes in regulations and guidelines, interpreting their impact on our products and processes

Documentation and Submissions

• Prepare and submit regulatory documents for product approvals, licenses, and permits
• Review and approve product labeling, packaging, and promotional materials for compliance
• Maintain accurate records of regulatory submissions and correspondence

Cross-functional Collaboration

• Work closely with R&D, clinical trials, and legal teams to ensure regulatory compliance throughout product development
• Provide regulatory guidance to various departments and senior management

Regulatory Strategy

• Develop and implement regulatory strategies for new and existing products
• Advise on potential regulatory risks and mitigation strategies

Agency Interactions

• Serve as a liaison between the company and regulatory authorities
• Participate in regulatory agency meetings and respond to their inquiries

Quality Assurance

• Contribute to the development and maintenance of quality assurance processes
• Assist in preparing for and managing regulatory inspections and audits

Pharmacovigilance

• Support post-market surveillance activities
• Evaluate and report adverse events and product complaints as required

Qualifications:

• Bachelor's degree in a scientific field such as Pharmacy, Chemistry, Biology, or related discipline; advanced degree preferred
• Minimum of 3-5 years of experience in regulatory affairs within the pharmaceutical industry
• In-depth knowledge of FDA, EMA, and other relevant regulatory guidelines
• Strong understanding of the drug development process and clinical trials
• Excellent analytical and problem-solving skills
• Superior written and verbal communication abilities
• Meticulous attention to detail and strong organizational skills
• Ability to work effectively in a team environment and manage multiple projects simultaneously

Darwin Recruitment is acting as an Employment Agency in relation to this vacancy.