Regulatory Affairs Strategy Director

Job Title:

Regulatory Affairs Strategy Director Job Description The Regulatory Affairs Strategy Director leads the systematic collection, analysis, and dissemination of global regulatory intelligence to inform enterprise policies, processes, and practices. This role enables subject matter experts to understand the impact of evolving regulatory requirements, translate regulatory changes into actionable guidance, and ensure ongoing compliance and continuous improvement. The director serves as a key cross‑functional partner across Research & Development, Quality Assurance, Pharmaceutical Supply Chain, and Information Technology to drive consistent, enterprise‑wide implementation of regulatory expectations. Responsibilities Lead the systematic collection, analysis, and dissemination of global regulatory intelligence to inform internal policies, processes, and practices. Monitor the external regulatory environment to identify emerging regulatory intelligence, including regulatory-related news, competitor product approvals, and submissions relevant to the organization. Identify, analyze, and proactively communicate regulatory developments and their potential impact to key stakeholders and leadership. Establish and maintain formal and informal networks to stay current with regulatory intelligence, trends, and interpretation. Interpret regulatory intelligence to assess its impact on the organization and provide clear, actionable advice to stakeholders and leadership. Monitor organizational strategic priorities and participate in cross-departmental discussions to ensure timely identification of targeted regulatory intelligence needs. Lead Regulatory Affairs action planning to update policies, processes, and procedures based on new regulatory intelligence and surveillance information. Develop, oversee, and monitor the completion of regulatory intelligence-related impact assessments and action plans to ensure timely and effective implementation. Establish cross-functional relationships and internal networks to plan impact assessments and coordinate action implementation resulting from new regulatory intelligence. Serve as the business owner for the enterprise regulatory intelligence system, ensuring it effectively supports regulatory monitoring and decision-making. Establish processes and performance measures to ensure Regulatory Affairs conformance with quality procedures and internal standards. Support audits and inspections by providing evidence of compliance and demonstrating robust regulatory intelligence and action planning processes. Develop and manage plans, establish timelines, and set performance standards for Regulatory Affairs intelligence and strategy activities. Proactively balance multiple commitments, overcome challenges, and ensure completion of multiple complex activities while delivering high-quality work. Apply extensive knowledge of the regulatory framework, industry drivers, and best practices to develop innovative approaches and manage complex regulatory work. Provide clear and effective verbal and written communication, including timely information updates and presentations to cross-functional groups. Demonstrate strong interpersonal skills by accommodating differing views and influencing stakeholders toward agreed-upon resolutions. Effectively lead and manage a high-performing team, facilitating alignment and achievement of common objectives that support departmental and organizational goals. Engage internal and external stakeholders to establish productive, collaborative relationships that support regulatory strategy and compliance. Provide regulatory expertise to cross-functional teams, gathering, analyzing, and applying key information to solve complex problems. Evaluate longer-term consequences of regulatory decisions and actions, ensuring alignment with organizational goals and strategic direction. Proactively assess workload, trends, tasks, and priorities within the area of responsibility to optimize resource allocation and delivery. Plan and execute multiple concurrent activities, considering alternative methods and contingency plans to avoid potential issues. Design and implement solutions to address project-level challenges, taking into account broader organizational impact and long-term implications. Act with integrity to build trust within the team and across the organization while executing on team objectives that contribute to regulatory and business success. Essential Skills Extensive experience in Regulatory Affairs within the pharmaceutical industry. Regulatory Affairs and oncology experience with a pharmaceutical company. Deep understanding of global regulatory frameworks, requirements, and industry practices. Proven experience in regulatory intelligence, including monitoring, analyzing, and interpreting regulatory developments. Demonstrated ability to lead regulatory action planning and implement updates to policies, processes, and procedures based on new regulatory intelligence. Strong background in regulatory submissions and related documentation. Ability to serve as a strategic partner across functions such as Research & Development, Quality Assurance, Pharmaceutical Supply Chain, and Information Technology. Excellent verbal and written communication skills, including the ability to present complex regulatory information clearly to cross-functional audiences. Strong interpersonal and influencing skills, with the ability to accommodate differing viewpoints and drive consensus. Proven leadership experience managing and developing high-performing teams. Advanced analytical and problem-solving skills, with the ability to gather, analyze, and apply key information to complex regulatory issues. Demonstrated ability to plan, prioritize, and execute multiple activities and projects simultaneously. Track record of delivering high-quality work while balancing multiple commitments and overcoming challenges. Ability to design and implement solutions that address project-level challenges and consider broader organizational impact. High level of integrity and commitment to regulatory compliance and quality. Additional Skills & Qualifications Bachelor's degree in a related discipline and a minimum of thirteen years of related experience, or Master's degree in a related discipline and a minimum of eleven years of related experience, or PhD degree in a related discipline and a minimum of eight years of related experience, or Equivalent combination of education and experience. Experience working with oncology products and associated regulatory pathways. Experience establishing and maintaining regulatory intelligence networks and systems. Experience supporting regulatory audits and inspections. Demonstrated ability to align regulatory strategies with organizational goals and strategic priorities. Experience leading cross-functional initiatives that impact enterprise-wide processes and procedures. Work Environment This is a contract role with an initial six-month term and the possibility of renewal. Onsite work is preferred; however, the position can be fully remote while working Pacific Time (PST) hours. The role involves close collaboration with cross-functional teams in Research & Development, Quality Assurance, Pharmaceutical Supply Chain, and Information Technology, using enterprise regulatory intelligence systems and quality management processes to support decision-making and compliance. Job Type & Location This is a Contract position based out of Alameda, CA. Pay and Benefits The pay range for this position is $100.00 - $150.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully remote position.

Application Deadline This position is anticipated to close on May 15, 2026. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through: Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people Actalent is an equal opportunity employer. About Actalent Actalent is a global leader in engineering and sciences services. For more than 40 years, we've helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day. Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.