Combination Products Regulatory Consultant

Syncromune • Fort Lauderdale, FL

2d • Remote

About The Position

The Combination Products Regulatory Consultant position will support activities on both the drug and device side and will support our drug and device regulatory strategy by providing regulatory filing support and interacting with regulatory agencies. They will report directly to the Senior Director of Regulatory Affairs. The contract will be part-time, 15-20 hours per week for a minimum of 6 months. Principal Duties and Responsibilities include the following: Planning and execution of regulatory meetings with FDA (Type C, EOP2 etc.) expedited approval programs in the US such as Breakthrough Designation , Fast Track, Orphan Drug etc. Provide strategic and regulatory support across our drug CMC development program and provide experienced regulatory guidance on various IND amendments (formulation optimization etc.). Provide regulatory intelligence to organization regarding changes that may impact drug/device combination product regulatory strategy This consultant may also support device development activities from a combination product perspective and other preclinical activities related to regulatory filings. Provide guidance on BLA filing strategy with FDA and global regulatory strategy with various foreign agencies. Review and assess regulatory risks impacting current regulatory designations and upcoming BLA filing Assist with regulatory submissions which may include IND’s, BLA’s, etc. Write and edit technical documents Support the development of standard operating procedures (SOPs)

Requirements

• Masters Degree/PhD in Life Sciences or related field
• 15+ years of experience in regulatory affairs, preferably in both drug and device
• 5-10+ years of experience in combination products – drug/device combination products preferred
• Experience authoring FDA regulatory submissions including NDA/BLA/IND.
• Knowledge and experience with 21 CFR 4 for regulation of combination products and interaction with the FDA office of combination products (OCP).
• Knowledge and experience with 21 CFR 820 for medical device and specifically design controls for device development.
• Experience assessing, implementing and managing regulatory changes on both the drug and devices side.
• Demonstrated success with FDA strategy, interactions, and execution across both drug and device.
• Excellent leadership, organizational and project management skills.
• Ability to work on multiple projects simultaneously with flexibility to take on new challenges as needed.
• Experience with global regulatory agencies.
• Experience with early-stage clinical pharmaceutical companies and working with CDMO’s during the CMC development phase.
• Strong knowledge of FDA regulations and policy surrounding combination products and strong understanding of regulatory risk.
• Ability to work in a fast-paced virtual environment.
• Excellent verbal and writing skills.
• Excellent knowledge of the competitive environment for drugs in the immuno-oncology marketplace and those currently in research and development pipelines.

Nice To Haves

• Regulatory Affairs Certification Preferred.
• Experience working with Oncology products preferred.

Responsibilities

• Planning and execution of regulatory meetings with FDA (Type C, EOP2 etc.) expedited approval programs in the US such as Breakthrough Designation , Fast Track, Orphan Drug etc.
• Provide strategic and regulatory support across our drug CMC development program and provide experienced regulatory guidance on various IND amendments (formulation optimization etc.).
• Provide regulatory intelligence to organization regarding changes that may impact drug/device combination product regulatory strategy
• Support device development activities from a combination product perspective and other preclinical activities related to regulatory filings.
• Provide guidance on BLA filing strategy with FDA and global regulatory strategy with various foreign agencies.
• Review and assess regulatory risks impacting current regulatory designations and upcoming BLA filing
• Assist with regulatory submissions which may include IND’s, BLA’s, etc.
• Write and edit technical documents
• Support the development of standard operating procedures (SOPs)

What This Job Offers

• Job Type: Part-time
• Career Level: Mid Level
• Number of Employees: 1-10 employees