VP Regulatory

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop and take charge of the regulatory strategy for the portfolio, including pathway selection, endpoint implications, pivotal design considerations, designations (such as breakthrough, orphan, and fast track), and the regulatory framework for each program's value-inflection point.

• Directly manage FDA interactions (Pre-IND, IND approval, End-of-Phase 2, Type B/C) as the primary representative from Lindus, while assisting the CDO and executive team in making critical regulatory decisions.

• Recruit and oversee external regulatory experts and key opinion leaders for specialized or region-specific inquiries, collaborating with CMC and clinical teams to ensure consistency in filings and agency submissions across different functions.

• Evaluate regulatory risks and the credibility of pathways during asset diligence, rigorously assess clinical development plans against anticipated agency positions, and compile regulatory intelligence to guide exit discussions.

⛳️ Requirements

• Over 15 years of experience in regulatory affairs within the biopharma industry, including at least the last 5 years in a senior strategy-leading position such as Senior Director, VP, Head of Regulatory Affairs, or Global Regulatory Lead, preferably at a company with a diverse portfolio.

• Successfully led a minimum of 5 FDA interactions, encompassing pre-IND, End-of-Phase 2, and Type B/C meetings, serving as the company's principal voice rather than in a supporting role. Experience with breakthrough, fast track, or orphan designation requests, as well as EMA scientific advice, is advantageous.

• Hands-on experience managing significant submissions throughout the development lifecycle: multiple INDs filed and maintained, plus involvement in at least one NDA or BLA (as the lead or a core contributor). Experience with post-approval or label negotiations is beneficial but not essential given our exit-before-commercialization approach.

• Proven strategy formulation for programs across various therapeutic areas and modalities (preference for small molecule and biologic exposure), or a strong ability to quickly familiarize oneself with new areas with KOL support.

• Experience working in a small, agile, or virtual biotech setting, ideally including asset in-licensing or acquisition diligence.

• Comprehensive understanding of pathway design, endpoints, and regulatory precedents that can either mitigate risk or jeopardize an asset, with the capability to translate that knowledge into clear go/no-go recommendations.

🏝️ Benefits

• Competitive salary, along with significant stock options.

• Flexible working: We offer a fantastic office near London Bridge and encourage a work-from-office schedule of 3 days per week.

• 30 days of annual leave plus Bank Holidays.

• £60 monthly wellness allowance, which can be utilized for our company health insurance scheme through AXA, a wellhub membership, or wellness activities and expenses of your choice!

• Enhanced Parental Leave: 16 weeks of full pay for the primary caregiver and 6 weeks for the secondary caregiver.

• £1,000 annual Learning and Development allowance for courses, certifications, and professional growth.

• Regular company-wide and team events, both in-person and virtual.

• Access to gym and retail discounts via our benefits platform, Happl.

• A fully stocked pantry and drinks fridge, along with a Monday breakfast spread and catered team lunch every Thursday for the UK office!

• Cycle-to-work scheme and other salary sacrifice options available.

• Opportunities for charity events and fundraising through our partnership with the Forward Trust.

• Health insurance coverage through our PEO, Trinet.

• 27 days of annual leave in addition to 11 National Holidays.

• $40 monthly wellness allowance, which can be spent on a wellhub membership or wellness activities and expenses of your choice!

• $2,000 annual Learning and Development allowance for courses, certifications, and development.

• Monthly lunch voucher for our remote teams.

• Opportunities for charity events and fundraising through our partnership with the Forward Trust.