Regulatory Affairs Manager

Regulatory Affairs Manager Boston

Flex week in Boston

Salary to $175,000.00

Our client in Boston is currently seeking a highly skilled and motivated Regulatory Affairs Manager to join our team. As a Regulatory Affairs Manager, you will play a critical role in leading the development of submission plans for worldwide regulatory submissions. Your expertise in regulatory affairs will ensure compliance with applicable regulations and guidelines, and facilitate the timely approval of our products.

Responsibilities:

• Lead the development and execution of submission plans for regulatory approvals worldwide, including marketing applications, clinical trial applications, and post-approval submissions.
• Collaborate with cross-functional teams to gather and review necessary documentation and data required for regulatory submissions.
• Ensure compliance with relevant regulatory requirements, guidelines, and standards in each target market.
• Conduct regulatory research to stay up-to-date with evolving regulations, guidelines, and industry trends.
• Develop and maintain strong relationships with regulatory agencies and authorities, acting as the primary point of contact during the regulatory review process.
• Prepare and submit high-quality regulatory dossiers and documentation, ensuring accuracy, completeness, and adherence to regulatory standards.
• Manage regulatory timelines, prioritize activities, and coordinate resources to ensure timely submission and approval of regulatory documents.
• Participate in regulatory strategy discussions, providing input on potential risks and opportunities.
• Monitor and track regulatory changes that may impact product development or commercialization plans.
• Provide guidance and support to internal teams on regulatory requirements, labeling, advertising, and promotional activities.
• Ensure compliance with post-market regulatory obligations, such as product variations, renewals, and reporting requirements.
• Train and educate team members on regulatory affairs processes and procedures.

Qualifications:

• Bachelor’s degree in a scientific or related field. Advanced degree is a plus.
• Minimum of 6 years of experience in regulatory affairs within the medical device/pharmaceutical/biotech sector.
• Proven track record of successful regulatory submissions and approvals.
• Strong knowledge of global regulatory requirements, including FDA regulations, EU regulations, and other relevant international standards.
• Familiarity with the drug/medical device development process and associated regulations.
• Excellent understanding of regulatory guidelines and documentation standards.
• Experience in preparing and submitting regulatory dossiers and managing regulatory timelines.
• Ability to interpret complex scientific and technical data and translate it into regulatory strategies.
• Exceptional attention to detail and strong analytical skills.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and regulatory agencies.
• Strong organizational and project management abilities.
• Regulatory Affairs Certification (RAC) is preferred.

EEO – All qualified applicants will receive consideration for employment without discrimination.