Senior Manager, Regulatory Affairs

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

📋 Description

• Oversee the preparation and coordination of U.S. IND submissions

• Ensure that IND submissions include necessary documents and comply with FDA standards

• Offer regulatory advice regarding U.S. IND processes, FDA meeting requests, and briefing materials

• Manage information requests from the FDA and responses from sponsors

• Assist in FDA regulatory interactions and maintain IND activities, such as protocol amendments, information amendments, CMC changes, safety reports, annual reports, and notifications

• Support NDA submissions, which include coordinating module content and pre-NDA meeting packages

• Monitor U.S. submission status and maintain documentation that is inspection-ready and regulatory archives

• Oversee the preparation, compilation, and submission of ex-U.S. CTAs, including EU CTIS and applications specific to individual countries

• Ensure that CTA packages adhere to regional and country-specific standards

• Provide guidance on EU CTIS and country-specific CTA procedures

• Handle inquiries from health authorities and sponsor responses

• Support maintenance activities for CTAs, including substantial modifications, IMPD updates, quality changes, annual updates, and notifications

• Assist in the preparation of MAAs and other ex-U.S. marketing applications

• Track the status of ex-U.S. submissions and maintain documentation that is inspection-ready and regulatory archives

• Contribute to the global regulatory strategy, health authority engagement plans, and submission timelines

• Keep abreast of evolving regulatory requirements in the U.S., EU, and ex-U.S. and evaluate their effects on development strategies

• Supervise regulatory vendors to ensure high quality and timely delivery

• Act as a regulatory liaison among internal teams and external partners

• Collaborate with Clinical Development and Clinical Operations on global study initiation timelines

• Work with CMC and Quality teams on IND, IMPD, and quality documentation

• Report to the Vice President of Regulatory Affairs

⛳️ Requirements

• Bachelor's degree

• At least 7 years of experience in regulatory affairs within biotech or pharmaceutical drug development, with a strong emphasis on U.S., EU, and ex-U.S. clinical trial submissions

• Proven hands-on experience with U.S. IND submissions, EU CTA submissions in CTIS, ex-U.S. CTA preparation and coordination, and managing health authority interactions and responses

• Strong understanding of U.S. FDA regulations, particularly 21 CFR Parts 312 and 314

• Solid knowledge of EU regulatory frameworks, including EU CTR 536/2014, EMA guidance, and CTA requirements, along with relevant ICH guidelines

• Experience in managing the lifecycle activities of IND and CTA, including amendments, updates, and ongoing maintenance

• Excellent project management and organizational skills

• Ability to work independently, handle multiple priorities, and meet deadlines in a fast-paced, lean environment

• Proven ability to draft clear and precise regulatory documents

• Detail-oriented with a strong commitment to quality and compliance

• Exceptional written and verbal communication skills, with a collaborative and team-focused approach

• Capacity to excel in a dynamic, fast-paced environment and adapt to change and uncertainty

• Flexible, proactive, and hands-on attitude

• Advanced degree (MS, PhD, PharmD) is preferred

• Preferred experience in regulatory submissions in the UK, Canada, Australia, South Korea, or LATAM

• Preferred experience in supporting NDAs and MAAs

• Preferred background in cardiovascular, rare disease, or small molecule drug development

• Familiarity with ex-U.S. CMC regulatory requirements is preferred

• Experience with Veeva RIM or similar document management systems is preferred

• Employment authorization confirmed through the federal E-Verify program

🏝️ Benefits

• Competitive total rewards package

• Eligibility for annual bonuses

• Eligibility for equity

• Comprehensive benefits offering