Regulatory Affairs Strategy Director

About the role

The Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership to the development, commercialization and life cycle management of assigned products. Serves as the global regulatory lead (GRL) on projects or specific indications of larger programs and/or as the regional regulatory lead.

Responsibilities

• Provides strategic and operational regulatory leadership to the development, commercialization and life cycle management of assigned products.
• Serves as the global regulatory lead (GRL) on projects or specific indications of larger programs and/or as the regional regulatory lead.
• Crafts and implements the clinical strategy and influences health authorities to improve outcomes.
• Works across disciplines in an atmosphere of collaboration and inclusion where Regulatory Affairs is a respected voice and considered an equal partner in the business.
• Defines the regulatory strategy for therapeutic assets and engages with Health Authorities to effectively inform development programs.
• Leads Major Health Authority interactions and evaluates risks to regulatory activities.
• Thinks strategically and critically to ensure the success of regulatory activities within a complex, business critical, and high-profile development program.

Requirements

• Advanced Degree in Life Science or related discipline.
• 5+ years of proven experience defining and implementing the regulatory strategy for a pharmaceutical organization.
• Extensive knowledge of regulatory affairs within one or more therapeutic areas in early and late development.
• Proven track record of regulatory drug development including product approval/launch.
• Experience in leading Major Health Authority interactions.
• Ability to think strategically and critically and evaluate risks to regulatory activities.
• Ability to work strategically within a complex, business critical and high-profile development program.

Qualifications

• Strategic thinking is key within our function.
• The more experienced you are, the more accountability you will have for strategic leadership including responsibility for development and implementation of the global regulatory strategy for a product/group of products of increasing complexity.

Skills

• Strategic thinking and critical evaluation of risks.
• Leadership in regulatory affairs.
• Collaboration and inclusion in regulatory strategy.
• Engagement with Health Authorities.
• Experience in major health authority interactions.

Benefits

Competitive Salary And Benefits Package
Annual base salary range: $186,232.80 - 279,349.20.
Short-term incentive bonus opportunity;
Eligibility to participate in our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly roles).

Benefits offered include:
- A qualified retirement program [401(k) plan]
- Paid vacation and holidays
- Paid leaves
- Health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.

Pay

The annual base salary for this position ranges from $186,232.80 - 279,349.20. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.

Schedule

If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.