Regulatory Affairs Manager

Position Summary

The Regulatory Affairs Manager independently and without appreciable direction, actively collaborates with R&D to author, prepare, review and submit high-quality regulatory submissions and communications within company timelines and in accordance with regulatory guidelines and applicable laws; acts as the company contact with FDA. 

Essential Duties

• Prepare, compile and finalize high-quality marketing authorization applications without appreciable direction (ANDAs in the US and MAAs in the UK and EU). Ensure compliance with eCTD Technical Specifications and FDA Study Data Technical Conformance Guide.
• Ensure submissions meet local (US, UK, EU) validation requirements to avoid any RTR (US) or validation failures (UK, EU). Perform critical detailed assessment that technical documentation and information is available, accurate and complete for submission
• Author all basic sections in Modules 1, Module 2 and Module 3.
• Manage ANDA Labeling activities together with vendor.
• Interface with suppliers/vendors to source necessary regulatory administrative documentation (e.g. cGMP certificates, Debarment certificates, US agent letters, DMF LoAs, Technical data sheets and technical drawings, quantitative compositions of resins and colorants, Elemental Impurities risk assessments, Nitrosamine risk assessments, etc.).
• Work directly with RegOps vendors on ANDA/MAA submission preparation and publishing.
• Organize and maintain submission components electronically. This may include scanning, converting to pdf, bookmarking, hyper-linking and electronic processing. Archive and maintain all submissions in a systematic way.
• Manage all amendments in response to IR, DRLs, RFIs. Respond to deficiencies/requests for information from regulatory agencies in a timely manner.
• Review API DMFs for potential deficiencies. Follow up with vendors on DMFs and DMF review comments, as appropriate.
• Ensure that project deadlines and performance standards for projects are established and met. Maintain full awareness of all regulatory activities on assigned projects.

Additional Responsibilities

• Prepare and submit Controlled Correspondences to FDA.
• Manage administrative regulatory correspondence with US (OGD, User fee staff, drug listing), and EU/UK Agencies.
• Interact with US/EU/UK Agencies and Regulatory Project Managers.
• Organize Pre-ANDA Meetings (US) and Scientific Advice Meetings (EU and UK). Prepare, review and file briefing documents for these meetings.
• Represent the Regulatory Affairs group in project team meetings and provide regulatory guidance and perspective to team members in determining appropriate actions in order to meet scheduling timelines and/or in resolving technical issues. Prepare and update the road map for each assigned product with committed timeliness by each department.
• Evaluate change controls and formulate strategies for correct filing categories. Proactively raise major project issues for resolution and agreement.
• Proactively engage with colleagues independently in resolving regulatory issues and/or problems.
• Perform administrative functions as directed by Management to support projects.

Work Arrangement

We are seeking a candidate who can work primarily on-site to foster collaboration with the team. We are located in Sunrise, Florida. For an exceptional candidate with the right experience and expertise, a remote work arrangement may be considered.

Education

• Bachelors Degree (BA/BS) in Science or Technical - Required
• Master Degree (MS/MA) in Science or Technical – Preferred

Work Experience

• 7 years or more of ANDA regulatory submission related experience required.

Skills And Abilities

• Time management, organization and planning skills, multi-tasking and prioritization skills in a fast-paced environment are required.
• Ability to maintain a high level of accuracy and attention to detail, while meeting deadlines for assigned projects.
• Excellent written and verbal communication skills and interpersonal skills.
• Ability to communicate effectively and collaboratively as part of a team in a respectful manner.
• Ability to work independently, self-starter.
• Good problem-solving skills and analytical ability.

Specialized Knowledge

• Strong skills in MS Word, MS Excel, MS PowerPoint, MS Outlook, Adobe Acrobat Professional.
• Proofreading abilities.
• Working knowledge and experience with applicable regulations 21 CFR, US FDA guidelines, ICH guidelines, US, EU and AU regulatory agencies.