regulatory manager - New York, United States - SBH Fashion

Description

Digitally Native, high growth skincare brand is seeking a highly skilled and experienced Regulatory Manager. 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 activities.

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 audits.

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 initiatives.

Provide regulatory guidance and support to project teams to ensure regulatory requirements are met throughout the product life cycle.
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.

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.
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 procedures.

Qualifications:
Bachelor's degree in a relevant scientific or technical discipline; advanced degree preferred.
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 markets.
Proven track record of successful regulatory submissions and approvals.
Strong analytical, problem-solving, and decision-making skills.
Excellent communication, interpersonal, and leadership abilities.
Ability to work effectively in a fast-paced, dynamic environment and manage multiple priorities simultaneously.
Certification in Regulatory Affairs (e.g., RAC) is a plus.
This position has a salary range of $110,00-$130,000. This salary is a good faith estimate for this position. The final salary offer will be determined after reviewing relevant factors, which include a candidate's qualifications and experience, where appropriate