Director, Regulatory Affairs

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

📋 Description

• Develop, implement, and provide guidance on regulatory strategies for North America pertaining to development programs.

• Ensure and sustain market access in North America that aligns with business goals.

• Collaborate with the global regulatory leader and key internal stakeholders.

• Oversee North American regulatory elements of compounds throughout development, post-approval, and product lifecycle stages.

• Offer leadership and strategic regulatory oversight for assigned projects.

• Interface with the FDA, Health Canada, and business partners on development, regulatory, and registration strategies.

• Provide line management, foster people development, and oversee performance management.

• Assist in the development and implementation of departmental policies.

• Deliver regulatory strategic and operational guidance along with project mentorship.

• Advise on clinical study requirements, marketing approvals, strategic development plans, risk assessments, critical issues, and interactions with health authorities.

• Supervise the preparation and submission of investigational and marketing registration documentation in the US and Canada.

• Review clinical trial and marketing application documents and amendments to ensure compliance with US and Canadian regulations.

• Liaise and negotiate with the FDA and Health Canada regarding drug development, regulatory challenges, approvals, and labeling modifications.

• Monitor the global regulatory landscape and evaluate its impact on business and product development initiatives.

• Facilitate the development of regulatory policies and standard interpretations of global regulations.

• Combine functional expertise with business insight to address problems and support decision-making.

• Train, develop, and manage a regional regulatory team through both direct and indirect reporting structures.

• Foster partnerships with senior stakeholders across various functions.

• Lead regulatory contributions to significant issues.

• Assist in the development and implementation of regulatory processes.

• Recruit, develop, manage, and mentor regulatory professionals.

• Cultivate a goal-oriented culture.

⛳️ Requirements

• Over 10 years of experience in the biotechnology or pharmaceutical sector.

• At least 5 years of experience in a Regulatory role with a comprehensive background.

• A Bachelor’s degree is mandatory.

• Experience as a lead in Regulatory Affairs with the FDA is preferred.

• Previous experience with both small molecules and biologics is preferred.

• Deep understanding of the drug development process, the pharmaceutical industry, the healthcare environment, regulatory requirements, and policy trends.

• Extensive experience with INDs/CTAs, NDAs/BLAs, lifecycle management, interactions with Health Authorities, regulatory team leadership, and the formulation of regulatory strategies.

• Proven history of significant regulatory achievements.

• Strong business acumen coupled with sound decision-making skills.

• Robust strategic abilities, creativity, and a knack for addressing strategic challenges.

• Capability to meet objectives within a cross-functional team or partnership setting.

• Exceptional verbal and written communication skills.

• Competence to analyze, define, and persuasively communicate complex issues.

• Proficient conflict resolution and negotiation skills.

• Strong negotiation capabilities and the ability to devise creative solutions.

• Aptitude for building trust and respect within the organization.

• Ability to prioritize and manage multiple projects concurrently.

• Experience with Microsoft Office suite.

• Familiarity with Veeva regulatory publishing.

• Skills in PowerPoint presentation creation and delivery.

• Capability to engage with external business partners and regulatory agencies.

• Availability for business travel of 10–20% as needed.

🏝️ Benefits

• Eligibility for an annual bonus plan for non-commercial roles.

• Eligibility for an incentive compensation plan for commercial roles.

• Discretionary equity awards.

• Voluntary participation in the Employee Stock Purchase Plan.

• Medical insurance coverage.

• Dental insurance coverage.

• Vision insurance coverage.

• 401(k) plan.

• Flexible Spending Account/Health Savings Account.

• Life insurance coverage.

• Paid Time Off.

• Wellness benefits.

• Equal opportunity employer.

• Reasonable accommodations available in the job application process.