Job Title: Senior Director/Director of Regulatory

Location: Remote

Pay: $150,000 - $225,000 (dependent on experience)

Summary :

As a Senior Director/Director of Regulatory Affairs, you are responsible for the provision of high-quality regulatory technical advice and development strategies for clients across a wide range of therapeutic indications and will provide regulatory strategy and leadership for all North America and/or International (inc. European) regulatory submissions. You will lead and support teams and efforts around major filing activities and Health Authority interactions, and will provide regulatory support to other departments, project teams, and committees. In this leadership role, you will support the further development of the Regulatory department and enhance corporate Regulatory functions and facilitate business development and proposals in this area.

About You :

• You have 12+ years or more relevant regulatory affairs experience.

• You possess a comprehensive understanding of financial management.

• You have expertise in all aspects of the drug development process inclusive of regulatory milestones and clinical trials methodology, including a working knowledge of protocols and indications being studied.

• You have specialized knowledge of regulatory activities including but not limited to submissions to regulatory authorities, including INDs/CTAs and amendments, ODDs, and PIPs.

• You can understand and communicate regulatory requirements for pharmaceutical development submissions during the life cycle of a product.

• You are experienced in pharmaceutical product development and marketing authorizations (MAA/CTAs/INDS/NDA and or BLA/sBLA) experience in filings in an eCTD format.

• You are eager to develop, coach, and mentor regulatory team members, ensuring the sharing of best practices across the team.

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.