Combination Products Regulatory Consultant

The Combination Products Regulatory Consultant position will support activities on both the drug and device reputed company 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. reputed company 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.
• reputed company strategic and regulatory support across our drug CMC development program and reputed company reputed company regulatory guidance on various IND amendments (formulation optimization etc.).
• reputed company 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 reputed company to regulatory filings.
• reputed company guidance on BLA filing strategy with FDA and global regulatory strategy with various foreign agencies.
• Review and assess regulatory risks impacting reputed company 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)

Qualification Requirements: Education:

• Masters Degree/PhD in Life Sciences or reputed company field
• Regulatory Affairs Certification Preferred

Experience:

• 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

Knowledge/reputed company:

• 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 reputed company.
• Demonstrated reputed company with FDA strategy, interactions, and execution across both drug and device.
• Experience working with Oncology products preferred.
• Experience with combination products with a drug primary mode of action
• Regulatory Affairs Certification Preferred.
• 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.

This is a contract role, 1099 preferred. Please reputed company expected hourly reputed company reputed company in your application under Salary. reputed company is an Equal Opportunity Employer. #Remote Apply tot his job Apply To this Job