Wilson Sonsini’s global life sciences practice, one of the largest in the U.S., is seeking a senior regulatory counsel to join our FDA regulatory group. Our clients span medical devices, drugs, biologics, diagnostics, digital health, research tools, cosmetics, dietary supplements, wellness products, and other consumer products, and many are developing novel therapeutics and next-generation technologies that require innovative FDA regulatory strategies for marketing authorization.
In this role, you will counsel biopharma companies at every stage of development, including pre-IND and pre-NDA/BLA meetings, review of INDs, NDAs/BLAs, and other FDA submissions, clinical trial endpoint negotiations, OTP INTERACT meeting preparation, and briefing package review. You will advise on pipeline strategy, FDA designations, exclusivity, PTE calculations, Orange Book listings, pharmacovigilance and adverse event reporting, quality and drug supply chain arrangements, and clinical studies. You will also support our corporate teams on M&A, asset deals, and IPOs, our contracting teams on various agreements and transactional matters, and our patent teams on PTE calculations and Hatch-Waxman matters.
Ideal candidates have at least 10 years of industry experience life sciences, including law firm experience and senior counsel work experience at FDA CBER or CDER. Candidates must have stellar academic credentials and excellent verbal, written, and interpersonal skills.
Successful candidates may sit in Seattle, Washington DC, Boston, San Francisco, Palo Alto, or San Diego, with other locations considered for exceptional candidates.
Compensation and Benefits
- Salary range of $435,000, based on year classification.
- Discretionary merit bonuses may also be awarded.
- Our benefits include:
- Monthly wellness reimbursements
- 24/7 emotional and behavioral health support and virtual counseling
- Healthcare coverage for you and your same- or opposite-sex spouse/domestic partner and children up to age 26
- Family-building benefits including IVF, adoption, surrogacy, and egg-freezing
- Paid parental leave
- Parenting support concierge and telemedicine
- Parents and caregivers resource group
- Career coaching for working parents
- In-home and center-based back-up childcare
- Tutoring and college coach for older children
- Health Savings Accounts with firm contribution
- Flexible spending accounts
- 401(k) retirement plan
- Pretax commuter and parking benefits
- Basic and supplemental life insurance
- Short and long-term disability
- Voluntary long term care insurance
- Voluntary critical illness, hospitalization, and accident insurance
- Voluntary ID theft protection
- Voluntary pet insurance
- Medicare consulting
- Access to discounts: gym, fitness centers, local businesses, and more
- Firm-paid CLE, bar review fees, and bar dues