Regulatory Affairs Manager

• Develop and execute regulatory strategies for product approvals in compliance with local and international regulations.
• Prepare and submit regulatory filings, including applications, registrations, and dossiers, ensuring accuracy and completeness.
• Stay updated on regulatory changes and industry trends to advise the team on potential impact and adaptation strategies.
• Liaise with regulatory agencies and authorities to facilitate approvals and address any regulatory inquiries or issues.
• Collaborate with internal teams to provide regulatory guidance throughout the product development lifecycle.
• Preparation and submission of A/NDA submissions (initial, amendments, supplements, annual reports, 15-day Alert Reports); drug master files (initial, amendments, annual reports); plant/site master files; licenses, permits, and registrations to meet FDA and State requirements (especially Florida); other submissions as required.
• Prepare and submit all federal, state, and local permits in a timely manner.
• Interact with Customers and gather information as needed to support registration activities.
• Provide regulatory impact assessment on all change controls as required.
• Assist in the preparation of standard operating procedures (SOPs) associated with job function.
• Review and approve SOPs requiring the regulatory function participation under direction of the Group Leader
• Collaborates with Subject Matter Experts (SME)s, management, and supervisory personnel from applicable areas to resolve problems affecting product quality.
• Collaboration includes investigating and CAPA initiation, following up on issues and working jointly towards resolution.
• Prepare APRs in accordance with site procedures and timelines.
• Prepare complaint investigation reports and work closely with others on site events to verify scope of investigations, assure root cause analysis and batch impact assessment are adequate, and recommend corrective actions to prevent deviation recurrence; ensure on time closure.
• Assess product complaints and APR trends, provide guidance, and collaborate on plans of action to address trends as per site SOPs.
• May author other types of quality system documents as directed or assigned by QA management.
• Liaise with customers to ensure customer requirements are satisfied.
• Facilitate CAPA commitments and Effectiveness Checks, including initiation, tracking, trending, and closure.
• Author/compile monthly, quarterly, and annual summaries and metrics
• Site management in driving and enforcing cGMPs.
• Mentoring other individuals within the organization in compliance.
• Participating in Internal Assessments.
• Facilitating routine compliance and CAPA Review Board meetings, including follow up actions, facilitating and conducting training.

Requirements:

• Bachelor's degree in a relevant field (e.g., Regulatory Affairs, Life Sciences, Pharmacy, etc.); advanced degree preferred.
• 5+ years of experience in regulatory affairs within [mention specific industry or sector].
• In-depth knowledge of regulatory requirements and standards (FDA, EMA, etc.).
• Strong communication skills and ability to work collaboratively in cross-functional teams.
• Proven track record of successful regulatory submissions and approvals.