Regulatory Manager

Reporting to: VP of Product

Department: Product Full Time/Salaried

Salary Range:$110-130K

Location: This position is based in our New York City office, 3 days a week in the SOHO Office

Position Overview:

We are seeking a highly skilled and experienced Regulatory Manager to join our team. The Regulatory Manager will be responsible for ensuring compliance with all relevant regulations, standards, and guidelines governing our industry. They will oversee regulatory affairs, provide strategic guidance to internal teams, and interface with regulatory authorities as necessary to maintain compliance and facilitate product approvals.

Key Responsibilities:

Regulatory Compliance:

• Monitor, interpret, and ensure compliance with local, national, and international regulations and standards pertinent to our industry.
• Develop and implement regulatory strategies to support product development, registration, and marketing

Documentation Management:

• Oversee the preparation, review, and submission of regulatory documents, including but not limited to, applications, notifications, and reports required for product approval and maintenance.
• Maintain comprehensive regulatory files and databases to support regulatory submissions and

Cross-functional Collaboration:

• Collaborate closely with internal departments such as Research & Development, Quality Assurance, and Marketing to integrate regulatory considerations into business processes and product development
• Provide regulatory guidance and support to project teams to ensure regulatory requirements are met throughout the product life cycle.

Regulatory Intelligence:

• Stay abreast of changes in regulatory requirements, guidelines, and best practices, and communicate relevant updates to internal stakeholders.
• Assess the impact of regulatory changes on existing products and processes and recommend appropriate actions to maintain compliance.

Regulatory Liaison:

• Serve as the primary point of contact for regulatory agencies and notified bodies, representing the company in regulatory interactions, submissions, and audits.
• Build and maintain positive relationships with regulatory authorities to facilitate timely approvals and resolve regulatory issues.

Risk Management:

• Conduct risk assessments to identify and mitigate regulatory risks associated with product development, manufacturing, and distribution activities.
• Implement and maintain robust regulatory risk management processes and

Qualifications:

• Bachelor's degree in a relevant scientific or technical discipline; advanced degree
• Minimum of 5 years of experience in regulatory affairs within the pharmaceutical, medical device, biotechnology, or related industry.
• In-depth knowledge of regulatory requirements and guidelines applicable to the company's products and

• Proven track record of successful regulatory submissions and
• Strong analytical, problem-solving, and decision-making
• Excellent communication, interpersonal, and leadership
• Ability to work effectively in a fast-paced, dynamic environment and manage multiple priorities
• Certification in Regulatory Affairs (e.g., RAC) is a plus