The Regulatory Affairs Director (RAD) is responsible for providing strategic regulatory leadership to the development, commercialization and life cycle management of assigned product(s). The RAD applies knowledge of current local and global regulatory trends to identify future regulatory requirements and strategies and influences regulatory authorities through regular contacts to improve regulatory outcomes.

Accountabilities

• Develop and implement the regional or global regulatory strategy, ensuring it is crafted to deliver rapid approval with competitive labelling that is identified by the business, markets and patients

• Lead the development of the global regulatory strategy document for assigned product(s) and the planning and construction of the global dossier and core prescribing information

• Lead cross functional teams in major regulatory submissions (BLA/MAA/IND/CTA), health authority interactions, label discussions, and securing approvals

• Deliver regulatory milestones for assigned project(s), including the assessment of risks and mitigations, emerging data and the probability of regulatory success

• Ensure effective collaboration across global, regional and local Regulatory Affairs, enabling rapid and effective submissions, approvals and other product maintenance activities

• Participate in skill-development, coaching and performance feedback of other regulatory staff working on the product/project

Minimum Qualifications:

• Bachelor's Degree in a life science or related field.

• 7+ years of experience in regulatory drug development, manufacture, commercialization or equivalent

• Broad background of experience of working in several groups in regulatory affairs or experience at a health authority

• Knowledge of regulatory procedures and legislation for drug development, marketing approvals, line extensions and license maintenance

• Proven successful leadership and project management experience

• Excellent oral, written, and presentation skills

• Ability to work in a fast-paced environment in a hands-on fashion

Desirable Qualifications:

• Advanced degree in science related field and/or other appropriate knowledge/experience

• Previous experience in vaccines or anti-infective therapies

• Ability to work strategically in a global regulatory lead role on business-critical and high-profile development programs

• Experience supporting a global regulatory approval or major submission activity

• Experience with FDA advisory committee or EMA oral explanation preparation

• Experience working on due diligence activities or in a business alliance environment

The annual base pay for this position ranges from $186,232 - $279,349 USD Annual. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. 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.

Date Posted
28-Sep-2026

Closing Date
12-Oct-2026