Senior (5+ years of experience)
Summary of the Role
The Regulatory Affairs Manager is responsible for overseeing the regulatory process for companies in the healthcare industry, including pharmaceuticals, medical devices, and biotechnology. They ensure that products comply with all of the applicable regulations and laws pertaining to their business. This role involves strategic planning and collaboration with regulatory authorities, product development teams, and senior management.
Required Skills
Strong understanding of global regulatory requirements and ability to apply them strategically.
Proficiency in preparing and submitting regulatory documents.
Exceptional attention to detail and the ability to manage multiple projects simultaneously.
Strong analytical and problem-solving skills.
Highly effective team management and mentoring abilities.
Excellent negotiation and interpersonal skills, with the ability to build and maintain relationships with regulatory authorities.
Proficiency with regulatory information systems and databases.
Ability to stay abreast of regulatory changes and industry trends.
Qualifications
Bachelor's degree in a related field, such as biology, chemistry, or pharmacology.
Advanced degree (MS or PhD) in a scientific or related field is a plus.
Minimum of 5 years of experience in regulatory affairs within the healthcare industry.
Proven track record of successful FDA submissions and approvals.
Experience in international regulatory submissions, including EU, Canada, and emerging markets.
Thorough understanding of the drug development process and regulatory requirements across multiple jurisdictions.
Demonstrated leadership and project management skills in a regulatory environment.
Excellent written and verbal communication skills, with the ability to effectively communicate at multiple levels within the company.
Responsibilities
Develop and implement strategies for the fastest possible approval of regulatory submissions.
Serve as the primary contact for regulatory authorities and maintain positive relationships.
Provide regulatory input to product lifecycle planning and risk management.
Monitor regulatory outcomes of initial product concepts and provide input to senior management.
Manage regulatory submission processes for new product licenses, renewals, and post-marketing modifications.
Ensure compliance with current regulations, maintaining an up-to-date understanding of laws, legislation, and regulatory policies related to the company's products.
Coordinate and prepare documentation packages for submission to regulatory agencies.
Review product labeling and marketing materials to ensure compliance with regulatory requirements.
Lead or support various regulatory compliance projects, audits and inspections.
Mentor and manage a team of regulatory professionals.