The Regulatory Affairs Manager is a position that mainly supports the business operations in the areas of regulatory compliance and is responsible for planning, coordinating and implementing regulatory strategies related to the manufacture, packaging and distribution of our OTC (monographed) drugs, OTC medical devices (class I/II), and cosmetics.
Duties and Responsibilities:
· Interact with state and national regulatory agencies on a regular basis.
· Keep up to date on regulatory policy and procedural changes that could affect the company’s operations.
· Work with cross-functional teams to help them keep compliant with regulatory aspects of new product development and on-market items.
· Review all labeling and promotional materials through all mediums to ensure they’re truthful and fair.
· Author and maintain 510(k), DMRs, DHRs, UDIs, QIL, SDS, COA and other technical documentation.
· Prepare device listings, GUDID registration, OTC drug listings, site registrations, renewal fees, and other regulatory submissions.
· Interact with suppliers with respect to required testing and compiling of Regulatory documentation for existing and new formulas, along with tracking of any changes.
· Lead the Stability Program to validate OTC drugs for expiration dating and to comply with FDA and ICH guidelines.
· Manage the consumer, safety, analytical, and clinical testing needed for products and their claims’ substantiations.
· Procure and file licenses and legal documents regarding the sales and transport of company's products.
· Support internal, client, vendor, and FDA audits, along with the implementation of corrective actions.
· Identify management of any major risk assessments such as a need for market recall/withdrawals.
· Collaborate with cross functional teams to log, investigate, and report customer complaints and adverse reactions.
· Optimize internal processes with continuous improvement and updated SOPs.
Job Type: Full-time
Pay: $110,000.00 - $140,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Flexible schedule
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Vision insurance
Experience level:
- 3 years
- 4 years
- 5 years
- 6 years
- 7 years
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Education:
Experience:
- FDA regulations: 6 years (Required)
- Lean manufacturing: 4 years (Required)
- CGMP: 7 years (Required)
Ability to Commute:
- White Plains, NY 10601 (Required)
Ability to Relocate:
- White Plains, NY 10601: Relocate before starting work (Required)
Work Location: Hybrid remote in White Plains, NY 10601