Job Summary:

The Senior Manager, Regulatory Strategy supports the development and execution of regulatory strategies for the company's portfolio of therapeutics in Immunology & Inflammation (I&I). This individual contributes to assigned programs under the guidance of the program team, with primary support for US regulatory activities and involvement in ex-US submissions including EMA filings. Working cross-functionally with Clinical, Medical Affairs, and Program Leadership, this role helps advance products from IND/CTA through BLA/NDA/MAA submission across autoimmune and inflammatory conditions. The ideal candidate brings working knowledge of FDA and global regulatory frameworks, sound regulatory judgment, and the ability to operate with agility in a fast-paced, resource-lean biotech environment.

Work Arrangement & Location:

Hybrid - This position follows a hybrid work schedule, requiring a minimum of two (2) days on-site per week - currently designated as Tuesday and Wednesday. Additional on-site days may be required based on business needs, team priorities, or leadership direction.

Essential Duties and Responsibilities:

• Support development and execution of regulatory strategies for assigned I&I programs, consistent with health authority expectations and business objectives.
• Contribute regulatory input to Integrated Development Plans (IDPs) and cross-functional program planning activities.
• Assist in assessing regulatory risk across the product lifecycle and help identify mitigation strategies in alignment with cross-functional partners.
• Support preparation of designation requests (e.g., Breakthrough Therapy, Fast Track, Orphan Drug) as applicable.
• Maintain current awareness of the external regulatory environment, including new guidance documents, legislation, and precedents relevant to the I&I landscape.
• Support preparation and execution of US FDA meetings (Type A, B, C), including meeting requests, briefing packages, meeting minutes, and follow-up correspondence.
• Coordinate planning, preparation, and review of regulatory submissions including INDs/CTAs, orphan drug applications, scientific advice packages, NDA/BLA/MAA filings, annual reports, and amendments.
• Support ex-US regulatory interactions, including EMA scientific advice and CTA filings, ensuring consistency with the overall regulatory strategy
• Perform other duties and responsibilities as assigned

Qualifications:

• Education: Bachelor's degree in a life sciences, pharmacy, or related field required; advanced degree (MS, PhD, PharmD) preferred.
• 5 years of regulatory affairs experience in the pharmaceutical or biopharmaceutical industry with a bachelor's degree, 3-4 years with an advanced master's degree, and/or 2 years with a doctoral degree (PharmD/PhD).
• Experience in I&I or adjacent therapeutic areas (e.g., rare disease, neurology, with immune-mediated components) preferred.
• Experience contributing to IND/CTA filings and NDA, BLA, or MAA submissions preferred.
• Exposure to FDA interactions; familiarity with Type B meeting processes and briefing document preparation is a plus.
• Working understanding of ICH guidelines, 21 CFR Parts 312 and 314/601, and applicable international regulatory frameworks.
• Experience working in an early-to-mid stage biotech; comfort operating in ambiguous, high-growth environments
• Building effective partnerships with flexibility and adaptability. Commitment to integrity and working efficiently to achieve key team and business outcomes.
• Helps connect regulatory tactics to broader program and business strategy.
• Builds credibility and working relationships across cross-functional teams.
• Strong written and verbal communication skills; ability to synthesize regulatory information for varied audiences.

Salary Range:

The expected salary range for this position varies by location and will be communicated based on the country or region in which the selected candidate is hired. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by applicable local law. A discretionary annual bonus and long-term incentive award (e.g., equity) may be available based on individual and Company performance.

Salary Range

$150,000-$195,000 USD

Benefits:

We offer a comprehensive benefits package tailored to the country and region in which you are hired, in compliance with local laws and practices. Benefits may include, but are not limited to:

• Competitive health and wellness coverage (structure and premiums vary by country)
• Paid time off, public holidays, and additional leave entitlements in accordance with local requirements
• Flexible work arrangements / hybrid schedule

Benefits vary by location and are subject to eligibility requirements, local regulations, and plan terms. Specific benefit details applicable to your country or region will be provided during the offer process.