Sr Regulatory and Labeling Manager

We are currently seeking a Sr Regulatory and Labeling Manager to join our team. In this role, you will be responsible for overseeing all regulatory compliance and labeling activities. You will collaborate with cross-functional teams to drive regulatory strategies and ensure product compliance with applicable regulations and standards. The ideal candidate will have a strong background in regulatory affairs and labeling, along with excellent attention to detail and organizational skills.

Responsibilities

• Develop and implement regulatory strategies to support the timely approval and maintenance of products.
• Ensure compliance with regulatory requirements and standards, including FDA, EU, and other global regulations.
• Work closely with cross-functional teams to provide guidance and support on regulatory requirements and considerations.
• Review and approve labeling and promotional materials to ensure compliance with regulations and standards.
• Manage regulatory submissions, including the preparation and submission of regulatory filings and documentation.
• Stay up-to-date with regulatory changes and industry trends to ensure compliance and mitigate risks.
• Provide training and support to internal stakeholders on regulatory requirements and procedures.
• Collaborate with external partners and regulatory agencies to resolve any regulatory issues or concerns.
• Lead internal audits and facilitate inspections by regulatory authorities.
• Participate in cross-functional projects to drive continuous improvement and ensure regulatory compliance.

Requirements

• Bachelor's degree in a scientific or related field; advanced degree preferred.
• Minimum of 8 years of experience in regulatory affairs, preferably in the pharmaceutical or medical device industry.
• Strong knowledge of FDA regulations, EU regulations, and other global regulatory requirements.
• Experience in developing and implementing regulatory strategies.
• Excellent understanding of labeling requirements and guidelines.
• Proven ability to successfully manage multiple projects and deadlines.
• Strong attention to detail and organizational skills.
• Excellent written and verbal communication skills.
• Ability to collaborate effectively with cross-functional teams.
• Knowledge of quality management systems and regulatory software tools is preferred.
• Regulatory certifications, such as RAC or CQA, are a plus.
• Ability to adapt to a fast-paced and dynamic work environment.
• Ability to travel ~60%

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan (401k, IRA)
• Paid Time Off (Vacation, Sick & Public Holidays)