Senior Manager – Regulatory Affairs

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

📋 Description

• Formulate and implement regional regulatory strategies for developmental programs.

• Offer regional regulatory advice and supervision for product development and registration strategies, including both nonclinical and clinical development.

• Organize, compile, review, and submit regulatory documents such as initial INDs, CTAs, NDAs, amendments, and supplements.

• Represent the Regulatory team in cross-functional meetings.

• Lead regulatory activities related to studies and provide strategic advice on study-level decisions.

• Oversee global study-level regulatory tasks, which include CTA and IND submissions, investigator document package reviews and approvals, as well as FDA submissions.

• Monitor regulatory and ethics submissions and approvals across various studies.

• Coordinate FDA and other Health Authority meetings with Regulatory leadership.

• Collaborate with project teams to plan, review, finalize, and approve regulatory submissions.

• Create, maintain, and communicate timelines for regulatory submissions.

• Review protocols, ICFs, IBs, CSRs, and DSURs to ensure compliance with ICH, FDA, EMA, and other relevant regulations.

• Work with CROs and vendors to plan and complete health authority submissions.

• Manage inquiries and commitments from regulatory agencies, coordinate written responses with subject matter experts, and provide status updates.

• Contribute to global regulatory submissions and strategic planning efforts.

• Maintain regulatory databases, submission logs, and correspondence logs.

• Review, write, and present regulatory guidelines and SOPs.

• Stay updated on US and global regulations, guidance, and standards for drug development and product registration.

⛳️ Requirements

• BA/BS degree in biological or physical sciences; advanced degree (e.g., PharmD or PhD) is preferred.

• Relevant experience in the pharmaceutical industry, specifically in regulatory affairs.

• A minimum of 3 years of industry experience is generally required for the Senior Manager level; more extensive experience and scope are expected for the Associate Director level.

• An equivalent combination of education and experience may be considered.

• Familiarity with US FDA and international pharmaceutical guidance and regulations, including 21 CFR, ICH, GCP, GMP, and EMA.

• Understanding of the drug development process and industry-standard practices.

• Proven experience in supporting eCTD-formatted submissions, including INDs, NDAs/BLAs, MAAs, annual reports, amendments, and supplements.

• Experience in coordinating or supporting responses to health authorities or other critical submission projects while adhering to timelines.

• Excellent written, oral, and interpersonal communication skills in English.

• Ability to collaborate effectively with regulatory colleagues and across the development organization.

• Capacity to provide strategic advice on regulatory and program-related matters.

• Problem-solving skills to address unexpected challenges or obstacles.

• Strong attention to detail, and the ability to organize, prioritize, and delegate assigned projects.

• Experience interacting with CROs in managing US eCTD IND submissions and ex-US CTAs for clinical trial activations is preferred.

• Proficient in Microsoft Office (Word, Excel, PowerPoint).

• Familiarity with Veeva electronic document management systems and document review tools.

🏝️ Benefits

• Competitive compensation package.

• Annual performance bonus.

• Company equity options.

• 401(k) plan with employer matching.

• Employee Stock Purchase Program (ESPP).

• Pre-tax commuter benefits (for transit and parking).

• Referral bonus for successful hires.

• Subsidized lunch and parking on in-office workdays.

• 100% employer-paid premiums for medical, dental, and vision coverage for you and your dependents.

• Health Savings Account (HSA) with annual employer contributions.

• Flexible Spending Accounts (FSA).

• Fertility and family-forming benefits.

• Expanded mental health support, including therapy and coaching resources.

• Hybrid work model offering flexibility.

• Flexible, “take-what-you-need” paid time off and company-paid holidays.

• Comprehensive paid medical and parental leave.

• Opportunities for skill development and internal mobility.

• Career development through regular feedback, ongoing education, and professional development programs via LinkedIn Learning, LifeLabs, and BetterUp Coaching.

• Financial rewards, peer-to-peer recognition, and growth opportunities.