5-7 years of senior FDA regulatory affairs experience.
Expertise in drugs, biologics, blood products, and/or medical devices.
In-depth understanding of the product development lifecycle.
Proven experience with regulatory submissions and interactions with agencies.
Solid background in clinical and preclinical development.
Ability to work cross-functionally with R&D, manufacturing, clinical, and product management teams.
Responsibilities
Serve as a senior regulatory SME for military-relevant medical solutions.
Develop and review effective regulatory strategies and submission plans.
Prepare and review INDs, NDAs, PMAs, and 510(k)s, among other documents.
Support productive interactions with FDA and other regulatory agencies.
Advise product managers on regulatory risks and lifecycle strategies.
Mentor teams on regulatory requirements and best practices.
Benefits
Comprehensive medical, dental, and vision insurance.
401(k) plan with company matching.
Tax-deferred savings options.
Supplementary benefits.
Paid time off and professional development opportunities.
Full Job Description
Arcetyp LLC is looking for a Senior DoD Regulatory Affairs SME - Drugs, Biologics & Medical Devices. This position is onsite and located in Fort Detrick, MD.
ESSENTIAL JOB FUNCTIONS:
Serve as senior regulatory SME supporting military-relevant drugs, biologics, blood products, medical devices and other medical solutions.
Develop and review regulatory strategies and submission plans.
Support interactions with FDA/regulatory agencies and sponsors.
Advise product managers/IPTs on regulatory risks, opportunities and lifecycle strategy.
Mentor teams on regulatory requirements and best practices.
NECESSARY SKILLS AND KNOWLEDGE:
Senior FDA regulatory affairs expertise.
Drugs, biologics, blood/blood products and/or medical devices.
Product development lifecycle.
Regulatory submissions and agency interactions.
Clinical and preclinical development.
Cross-functional work with R&D, manufacturing, clinical and product management.
MINIMUM QUALIFICATIONS:
Senior FDA regulatory affairs expertise.
Drugs, biologics, blood/blood products and/or medical devices.
Product development lifecycle.
Regulatory submissions and agency interactions.
Clinical and preclinical development.
Cross-functional work with R&D, manufacturing, clinical and product management.
PREFERRED QUALIFICATIONS:
Current WPAC Regulatory Affairs incumbent(s) highest-priority incumbent capture target.
Direct experience preparing IND/NDA/PMA/510(k) submissions.
FDA meeting and regulatory agency interaction experience.
Blood/biologics/combat casualty care regulatory experience.
DHA/DoD medical acquisition experience.
RAC or comparable regulatory certification.
Min. Citizenship Status Required: U.S Citizenship.
LOCATION: Fort Detrick, MD
COMPENSATION: Pay and benefits information for this position will be provided to interested candidates that apply. Arcetyp offers a package of compensation and benefits to full-time salaried employees. Pay and Benefits from our client: we value and reward our team's dedication and hard work. We provide a competitive base salary commensurate with your qualifications and experience. As an employee, you'll enjoy a comprehensive benefits package, including medical, dental, and vision insurance, a 401(k) plan with company matching, tax-deferred savings options, supplementary benefits, paid time off, and professional development opportunities.
