Responsibilities- Lead and/or oversee global regulatory CMC submissions (e.g., INDs, CTAs, BLAs, MAAs etc.) through product lifecycle.
- Proactively identify regulatory risks, opportunities, and mitigation strategies in alignment with objectives, and communicate to management, as needed
- Provide strategic regulatory guidance to TechOps and Quality organizations to ensure global compliance and readiness for clinical and commercial supply
- Serve as the primary interface with global regulatory agencies for CMC-related negotiations, milestone meetings, and information requests.
- Provides global regulatory input and support on product-compliance related activities including change controls, deviations, and investigations.
- Manage junior team members and contractors to support development activities
Education & Experience- BS/BA Degree in a Scientific Discipline, Advanced Degree (M.S., Ph.D., etc.) required
- 12 years' experience in Regulatory Affairs CMC in Pharma/Biotech
- Strong negotiation skills with health authorities (e.g. FDA, EMA) as well as submissions
- Experience with leading IND and Marketing Applications
- Experience with antibody drug conjugates and biologics
- Strong analytical, strategic thinking, and problem-solving skills.
- Excellent communication and leadership abilities; able to influence across all levels of the organization.
- Ability to thrive in a fast-paced, ambiguous environment while managing competing priorities.
- Commitment to fostering a diverse and inclusive workplace
What We Offer- Opportunity to join a mission-driven team where you'll contribute to impactful work, take on varied responsibilities, and grow quickly in a dynamic environment
- Competitive compensation, including base salary, performance bonus, and equity
- 100% employer-paid benefits package
- Flexible PTO; also, two, one-week company-wide shutdowns each year
- A commitment to your professional development, with access to resources, mentorship, and growth opportunities
Salary RangeThe salary range for this position is $290,000 to $323,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.
Additional Description for Pay Transparency:The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability. Subject to the terms of their respective plans, employees are eligible to participate in the Company's savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation - Unlimited PTO; Sick time - 10 days per calendar year; Holiday pay, including two Company shut downs; Parental Leave - 16 weeks within one year of the birth/adoption/foster care of a child; FMLA; Military Leave. Additional information can be found - https://www.crescentbiopharma.com/careers/#benefits
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