Director of Regulatory Affairs - REMOTE

Job Description: · Provides senior regulatory leadership and strategic guidance to support late-stage clinical development programs, ensuring alignment with global regulatory requirements. · Acts as the primary regulatory lead for a fast-paced biotech environment, partnering cross-functionally to drive regulatory strategy through Phase III and preparation for potential registration. Key Responsibilities: · Lead global regulatory strategy for Phase III clinical programs, with a focus on vaccines. · Provide hands-on leadership for regulatory submissions and interactions (e.g., FDA, EMA), including NDA/BLA readiness where applicable. · Serve as interim Regulatory Affairs Lead, ensuring continuity of ongoing programs and regulatory commitments. · Advise internal stakeholders on evolving regulatory requirements and risk mitigation strategies. · Support preparation, review, and delivery of high-quality regulatory documents and submissions. · Act as key liaison with clinical, CMC, and executive teams in a high-pressure, fast-moving biotech setting Qualifications: · Extensive Regulatory Affairs experience (typically 12–15+ years) in biotech/pharma. · Proven experience leading global regulatory strategy for Phase III clinical programs. · Vaccine experience strongly preferred Prior experience with NDA/BLA submissions or late-stage regulatory interactions is a plus. · Demonstrated ability to operate effectively in fast-paced, high-pressure environments · Strong leadership, communication, and stakeholder management skills Pay: $210,000.00 - $235,000.00 per year Application Question(s):

• - Do you have Regulatory Strategy experience for "Phase III Clinical Programs?"

- Do you possess Vaccines experience? - Do you Possess CMC and Biotech / Pharma exp. ? Experience:

• Regulatory Affairs: 10 years (Required)

Language:

• Clear English (Required)

Work Location: Remote Apply tot his job Apply To this Job