Vice President, Regulatory Affairs and Quality

Company: Chikara Capital
Location: San Francisco, CA

Apply

Job details
Job Type
Full-time
Benefits
Pulled from the full job description
  • Health insurance
  • Dental insurance
  • Vision insurance
  • Retirement plan
  • Signing bonus
  • Paid time off
Qualifications
  • Experience:
    • biotech and pharma, 10 years (Preferred)

    • Director / Senior Director / VP, 5 years (Required)

    • Regulatory Affairs, 10 years (Required)

  • Full Job Description

    Snapshot: Regulatory Affairs leader wanted. Clinical stage biotech. Novel autoimmune, inflammatory and renal diseases. FDA Fast-Track recipient. Orphan Drug designation. Validated therapeutic molecule. Veteran leadership. Nimble team. Flat hierarchy. Be heard. Make progress. Love the journey.

    Company philosophy, direct from the leaders:

    “We’re really committed to finding and hiring really great, intelligent people, giving them plenty of opportunities to learn and to contribute beyond their role. We’re committed to not over-staffing and growing too quickly, to make sure the workforce is challenged enough. This gives everyone a chance to get involved with different types of work outside the formal scope of their roles, keeping them engaged and learning.”

    “We’re all motivated by the same goal; going after tough to treat diseases with huge unmet need, with few or no approved therapies. We all think it’s a challenge worth rising to, not just for the patients but for us. It’s a test of our skills and abilities. It’s a great thing to look forward to every day.”

    “Everyone here shares a sense of urgency, but it’s not stressful. The urgency comes from wanting to get medicines to patients as soon as possible.”

    “We like to have fun and share a joke. We really enjoy working together.”

    “Products may succeed or fail. There’s only so much we can do as developers. Sometimes things just don’t work. You’ll see your work colleagues more than your family, so you need to enjoy working with them and to enjoy the journey.”

    About the role

    This is a full-spectrum leadership role with responsibility for the Regulatory and Quality functions.

    • Develop and implement insightful, effective, global regulatory strategies for successful product registration and post-approval product management.
    • Build and manage a high-performing Regulatory team.
    • Oversee the development and implementation of Quality systems and direct internal and Quality activities.
    • Play an integral role in business development activities.
    • Base yourself at the Company’s La Jolla, San Diego or South San Francisco offices
    • Competitive compensation package targeting the 70th percentile including base, bonus and equity.

    Contact Regan at Chikara Capital for a confidential discussion.

    Chikara Capital – Talent Solutions for early-stage life science companies.

    Additional Compensation:

    • Bonuses

    Work Location:

    • One location
    • Multiple locations

    Benefits:

    • Health insurance
    • Dental insurance
    • Vision insurance
    • Retirement plan
    • Signing bonus
    • Paid time off
    • Flexible schedule