Principal Scientist, Regulatory Liaison

Scorpion Therapeutics; Rahway (NJ); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Medical/dental/vision

401(k) retirement plan

Paid holidays and vacation

Sick/compassionate days

Job summary

Scorpion Therapeutics seeks a Regulatory Affairs Headquarters Principal Scientist (Vaccines & Infectious Disease) to lead global regulatory strategy and act as the single point of contact for assigned products. You will liaise with FDA, prepare for advisory committees, and coordinate cross-functional regulatory support across regions.

The role requires advanced degrees with substantial regulatory affairs experience; vaccine/ID background highly preferred, and strong communication is essential

Qualifications

• MD: 3+ years drug development/clinical; OR PhD: 5+ years; OR MS: 7+ years (preference regulatory affairs).
• Excellent oral and written communication; strong organization; flexibility; scientific and analytical skills; capable of delivering results with limited day-to-day direction.
• Substantial regulatory affairs experience preferred; vaccines/infectious disease experience (antibacterial/antiviral).

Responsibilities

• Provide regulatory oversight for assigned products as the single global regulatory point of contact (GRACS and external to GRACS).
• Develop worldwide regulatory strategy to optimize labels and shortest time to approval across multiple indications.
• Advise Product Development Teams and subsidiaries on regulatory issues across the drug life cycle.
• Lead the Global Regulatory Team and coordinate cross-functional regulatory support.
• Communicate directly with FDA (calls/email), chair FDA meetings, and prepare teams for FDA meetings.
• Lead/adapt cross-functional preparation for advisory committees; may speak at committees.
• Coordinate interactions with foreign agencies via Regulatory Affairs Europe and subsidiaries; provide multi-region strategic direction.
• Review and provide final approval for Worldwide Marketing Applications, Clinical Study Reports, Protocols, and Investigators Brochures before external release.
• Represent GR on internal committees and conduct initial IND/Clinical Study Agreement content review/approval.
• Participate in regulatory due diligence for licensing candidates and support business development regulatory responsibilities.

Skills

Communication skills

Organizational skills

Flexibility

Analytical skills

Independent work

Education

MD or PhD or related doctoral degree; or MS with regulatory affairs experience

Job description

Role: Regulatory Affairs Headquarters Principal Scientist (Vaccines & Infectious Disease)

• Provide regulatory oversight for assigned products as the single global regulatory point of contact (GRACS and external to GRACS).
• Develop worldwide regulatory strategy to optimize labels and shortest time to approval across multiple indications.
• Advise Product Development Teams and subsidiaries on regulatory issues across the drug life cycle.
• Lead the Global Regulatory Team and coordinate cross-functional regulatory support.
• Communicate directly with FDA (calls/email), chair FDA meetings, and prepare teams for FDA meetings.
• Lead/adapt cross-functional preparation for advisory committees; may speak at committees.
• Coordinate interactions with foreign agencies via Regulatory Affairs Europe and subsidiaries; provide multi-region strategic direction.
• Review and provide final approval for Worldwide Marketing Applications, Clinical Study Reports, Protocols, and Investigators Brochures before external release.
• Represent GR on internal committees and conduct initial IND/Clinical Study Agreement content review/approval.
• Participate in regulatory due diligence for licensing candidates and support business development regulatory responsibilities.

Education (minimum)

M.D. or Ph.D. or related doctoral degree; or master’s with substantial regulatory affairs experience.

Required experience/skills

M.D.: 3+ years drug development/clinical; OR Ph.D.: 5+ years; OR M.S.: 7+ years (preference regulatory affairs).

Excellent oral/written communication; strong organization; flexibility; scientific/analytical skills; independent results with limited day-to-day direction.

Preferred

Substantial regulatory affairs experience; vaccines/infectious disease experience (antibacterial/antifungal/antiviral).

Benefits (as stated)

• Comprehensive benefits including medical/dental/vision, retirement (401(k)), paid holidays, vacation, and sick/compassionate days.