Job Description
Roles & Responsibilities
- Provide regulatory input and support for product labeling, advertising, and promotional materials.
- Ensure compliance with regulatory requirements and guidelines for product development, registration, and post-market activities.
- Prepare and submit regulatory submissions, including product registrations, variations, and renewals.
- Review and interpret regulatory guidelines and communicate changes to internal stakeholders.
- Collaborate with cross-functional teams to develop and execute regulatory strategies for new product launches.
- Manage relationships with regulatory authorities and facilitate inspections and audits.
- Monitor and track regulatory developments and assess their impact on the organization.
- Conduct regulatory training for internal teams to ensure understanding and compliance.
- Maintain regulatory documentation and records in accordance with applicable regulations.
- Stay current with industry trends and best practices in regulatory affairs.
Desired Candidate Profile
- Minimum of a bachelor’s degree in a scientific or related field.
- 5+ years of experience in regulatory affairs within the pharmaceutical or medical device industry.
- Strong knowledge of regulations and guidelines for product development and registration.
- Experience in preparing and submitting regulatory submissions.
- Certification in regulatory affairs (e.g., RAC) is preferred.
- Solid understanding of scientific principles and ability to interpret technical data.
- Excellent communication and interpersonal skills for effective collaboration with cross-functional teams and regulatory authorities.
- Attention to detail and strong organizational skills to manage multiple projects and deadlines.
- Ability to adapt to changing regulatory requirements and prioritize tasks accordingly.
