Location: Waltham & Cambridge MA and Bridgewater NJ
Position Overview: This is a Pharma/Biotech leadership role focused on advancing pipeline and commercial programs to address unmet medical needs in rare blood disorders.
Key Responsibilities:
- Direct multiple innovative global regulatory strategies for product development and approval.
- Lead and influence project teams and committees to attain group goals.
- Interface with regulatory authorities and prepare major regulatory submissions.
- Guide, train, supervise, and prioritize the workload of direct reports.
Qualifications:
- 15+ years in the pharmaceutical/biotechnology industry with extensive hands-on global biologics strategy experience.
- Minimum of 10-15 years in Regulatory Affairs (RA).
- Comprehensive knowledge of applicable regulations and GCPs/GLPs.
- Strong leadership and communication skills.
- Ability to represent the department in project teams and external meetings.
- Strong organizational skills with the ability to prioritize workload.
- Effective written and oral communication skills.
Preferred Qualifications:
- International regulatory experience.
- Experience in the development of therapies for rare (orphan) and/or extremely rare (ultra-orphan) diseases.
- Doctoral degree in the sciences, Pharmacy, or Regulatory Science preferred.
Education: BA/BS/University degree required, preferably in Life/Health Sciences.
Compensation: Salary range is $180,000 to $275,000. The fee is 25% of the salary.
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