Implaion Recruiting
VP, Regulatory Affairs | REMOTE
Implaion Recruiting, Durham, North Carolina, United States, 27703
Vice President, Regulatory Affairs | REMOTE | Pre-IPO
Critical Elements
Directly oversaw, or significantly contributed to, 2+ successful NDAs
Global regulatory approvals
Significant post-approval experience
Inspection readiness - labeling
Small company background
Nimble - Adadptable - Entreprenurial
Support within aggressive risk parameters
Overview Were looking for a regulatory leader whos done this beforesomeone whos successfully led multiple NDA submissions, can guide a team through inspection readiness with confidence, and thrives in the dynamic pace of a small biotech. Reporting directly to an Executive Officer, youll play a central role in advancing our late-stage programs globally. This isnt a set the strategy and delegate positionits a roll-up-your-sleeves, be-in-the-details, steer-the-ship kind of role.
What You’ll Do
Take charge of planning, drafting, and submitting global regulatory filings including INDs, NDAs, CTAs, MAAs, and pediatric development plans owning everything from original submissions to post-approval documentation.
Lead cross-functional teams spanning nonclinical, clinical, CMC, stats, and operations, pushing programs forward while meeting tight timelines and quality expectations.
Drive strategic and hands-on regulatory operations throughout the product lifecycle from first-in-human to commercialization.
Partner with clinical and safety teams to manage labeling, risk mitigation strategies, pharmacovigilance requirements, and lifecycle management.
Interface directly with regulatory bodies (FDA, EMA, and others) and confidently lead agency meetings, teleconferences, and written communications.
Evaluate and implement fast-track mechanisms, adaptive design approaches, and other accelerated regulatory pathways to compress development timelines.
Ensure internal teams and external partners are aligned and equipped to meet regulatory milestones on time.
Oversee external regulatory writers and consultants, balancing internal ownership with outsourced support.
Maintain sharp awareness of global regulatory shifts including FDA, EMA, and evolving EU regulations and translate that into forward-looking action.
What You Bring
PharmD, PhD, or MD strongly preferred.
Minimum 10 years in Regulatory Affairs within biopharma, including substantial late-stage and global submission experience.
Hands-on leadership in at least two successful NDA submissions for novel therapeutics (rare disease background a plus), with meaningful post-approval involvement.
Proven track record preparing for and navigating regulatory inspections calm under pressure, thorough in execution.
Must have worked in a nimble, small-company setting and be energized by wearing multiple hats in a high-accountability, low-bureaucracy culture.
Strong command of international regulatory frameworks, including EU Clinical Trial Regulation and CTIS.
Comfortable leading Advisory Committee strategies and commercial label expansion efforts.
Fluent in GxP, FDA / ICH guidance, and global PV standards.
Experience with small molecule programs, ideally in immunology or autoimmune indications.
Skilled at toggling between high-level strategy and detail-driven execution you dont shy away from writing submissions yourself.
Clear communicator, quick thinker, strong collaborator, and decisive leader.
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Critical Elements
Directly oversaw, or significantly contributed to, 2+ successful NDAs
Global regulatory approvals
Significant post-approval experience
Inspection readiness - labeling
Small company background
Nimble - Adadptable - Entreprenurial
Support within aggressive risk parameters
Overview Were looking for a regulatory leader whos done this beforesomeone whos successfully led multiple NDA submissions, can guide a team through inspection readiness with confidence, and thrives in the dynamic pace of a small biotech. Reporting directly to an Executive Officer, youll play a central role in advancing our late-stage programs globally. This isnt a set the strategy and delegate positionits a roll-up-your-sleeves, be-in-the-details, steer-the-ship kind of role.
What You’ll Do
Take charge of planning, drafting, and submitting global regulatory filings including INDs, NDAs, CTAs, MAAs, and pediatric development plans owning everything from original submissions to post-approval documentation.
Lead cross-functional teams spanning nonclinical, clinical, CMC, stats, and operations, pushing programs forward while meeting tight timelines and quality expectations.
Drive strategic and hands-on regulatory operations throughout the product lifecycle from first-in-human to commercialization.
Partner with clinical and safety teams to manage labeling, risk mitigation strategies, pharmacovigilance requirements, and lifecycle management.
Interface directly with regulatory bodies (FDA, EMA, and others) and confidently lead agency meetings, teleconferences, and written communications.
Evaluate and implement fast-track mechanisms, adaptive design approaches, and other accelerated regulatory pathways to compress development timelines.
Ensure internal teams and external partners are aligned and equipped to meet regulatory milestones on time.
Oversee external regulatory writers and consultants, balancing internal ownership with outsourced support.
Maintain sharp awareness of global regulatory shifts including FDA, EMA, and evolving EU regulations and translate that into forward-looking action.
What You Bring
PharmD, PhD, or MD strongly preferred.
Minimum 10 years in Regulatory Affairs within biopharma, including substantial late-stage and global submission experience.
Hands-on leadership in at least two successful NDA submissions for novel therapeutics (rare disease background a plus), with meaningful post-approval involvement.
Proven track record preparing for and navigating regulatory inspections calm under pressure, thorough in execution.
Must have worked in a nimble, small-company setting and be energized by wearing multiple hats in a high-accountability, low-bureaucracy culture.
Strong command of international regulatory frameworks, including EU Clinical Trial Regulation and CTIS.
Comfortable leading Advisory Committee strategies and commercial label expansion efforts.
Fluent in GxP, FDA / ICH guidance, and global PV standards.
Experience with small molecule programs, ideally in immunology or autoimmune indications.
Skilled at toggling between high-level strategy and detail-driven execution you dont shy away from writing submissions yourself.
Clear communicator, quick thinker, strong collaborator, and decisive leader.
#J-18808-Ljbffr