Temporary Regulatory Affairs Strategy Director

Job Title: Temporary Regulatory Affairs Strategy Director
Location: Alameda, CA
Type: Contract
Compensation: 140/hr – 155/hr
Contractor Work Model: Onsite – Remote in PST
Hours: 40.0


Responsibilities

• Lead the systematic collection, analysis, and dissemination of regulatory intelligence to proactively inform policies, processes, and practices.
• Assist subject matter experts in assessing the impact of evolving global regulatory requirements and translating regulatory changes into actionable guidance.
• Develop, execute, and complete regulatory impact assessments and action plans to ensure ongoing compliance and process improvement.
• Serve as a key cross-functional partner across Research & Development, Quality Assurance, Pharmaceutical Supply Chain, and Information Technology to drive enterprise-wide implementation of regulatory expectations.
• Monitor the external regulatory environment to identify emerging intelligence, including regulatory news, competitor product approvals, and submissions.
• Establish relationships and networks to stay updated with regulatory intelligence and interpretation, and communicate findings proactively.
• Interpret regulatory intelligence to assess impact and advise stakeholders and leadership accordingly.
• Participate in cross-departmental discussions to ensure timely identification of relevant regulatory information aligning with strategic priorities.
• Lead regulatory action planning based on new intelligence, updating policies, processes, and procedures as needed.
• Support audits and inspections to demonstrate compliance with regulatory systems and procedures.

• Bachelor’s degree in a related discipline with minimum of thirteen years of relevant experience; or master’s degree with at least eleven years; or PhD with at least eight years; or equivalent education and experience.
• Regulatory Affairs and oncology experience within a pharmaceutical company required.
• Extensive knowledge of regulatory frameworks, industry practices, and development of innovative approaches to complex work.
• Strong verbal and written communication skills, including effective presentations and stakeholder updates.
• Excellent interpersonal skills with the ability to influence and accommodate differing views.
• Proven leadership of cross-functional teams, fostering collaboration and achieving objectives.
• Adept at managing multiple priorities, planning, and executing activities with strategic insight.
• Ability to proactively assess workload, trends, and risks, designing solutions to address challenges.
• Knowledge of regulatory systems, compliance standards, and audit processes.

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions 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 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.

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Ref: #568-Clinical