Back to Jobs search

Temporary Regulatory Affairs Strategy Director

System One • Alameda, CA • 2h ago

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.

Requirements

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.

M-

LI-

Ref: #568-Clinical

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.

Similar Jobs

Pest Controller

Veterans Affairs, Veterans Health Administration • Palo Alto, CA • 1h ago

Finance, Accounting & Banking

Summary This is the full performance level of the position. The position serves as Pest Controller, and is located in the Environmental Management Service at the VA Palo Alto Health Care System (VAPAHCS). This position r...

1h ago

Go to Apply

Accounts Payable Specialist

Robert Half • San Leandro, CA • 1h ago

Finance, Accounting & Banking

Description Are you an experienced?Accounts Payable Specialist?with expertise in?Sage Intacct? Robert Half is seeking a detail-oriented and tech-savvy detail oriented to support accounts payable functions for one of our...

1h ago

Go to Apply

Accounts Payable Specialist

Robert Half • Pleasanton, CA • 1h ago

Finance, Accounting & Banking

Description Our team is seeking an Accounts Payable Specialist to join our Full-Time Engagement Professionals practice, a solution that provides clients with full-time professionals who can support critical projects and...

1h ago

Go to Apply

Accounting Manager | Private Equity Real Estate

Robert Half • Oakland, CA • 1h ago

Finance, Accounting & Banking

Description Fund Accounting Manager - Real Estate Private Equity Jennifer Fukumae with Robert Half Finance & Accounting is partnering with a private equity real estate investment firm seeking a Fund Accounting Manage...

1h ago

Go to Apply

Accountant I/II - County Executive's Office (Open and Promotional)

San Mateo County, CA • Redwood City, CA • 1h ago

Finance, Accounting & Banking

Accountant I/II - County Executive's Office (Open and Promotional) Print ( https://www.governmentjobs.com/careers/sanmateo/jobs/newprint/5337779 ) Apply ? Accountant I/II - County Executive's Office (Open and Promotional...

1h ago

Go to Apply

Amazon XL Warehouse Associate

Amazon • Fremont, CA • 3h ago

Manufacturing & Warehouse

Amazon XL Warehouse Associate Job Overview You'll be part of the Amazon warehouse team that handles the big stuff - those unique customer orders that weigh over 50 pounds: big-screen TVs, furniture, appliances, and more....

3h ago

Go to Apply

Staff Nurse II

Kaiser Permanente • Vallejo, CA • 3h ago

Hospital & Medical

Job Summary: The Registered Nurse (RN) II is a professional caregiver who assumes responsibility and accountability for a group of patients for a designated time frame. The RN II provides care to patients via the therape...

3h ago

Go to Apply

Advanced Medical Support Assistant

Veterans Affairs, Veterans Health Administration • Martinez, CA • 3h ago

Hospital & Medical

Summary The Advanced Medical Support Assistant (AMSA) will perform administrative support duties for the Diagnostic Imaging Service at the VA Northern California Health Care System (VANCHCS) in Martinez, California. The...

3h ago

Go to Apply

Fitness Coach

24 Hour Fitness, INC. • San Leandro, CA • 3h ago

FULL-TIME Part-time LOCATION 567 Floresta Boulevard San Leandro CA 94578 JOB SUMMARY The Fitness Coach represents 24 Hour Fitness to members and clients by delivering a positive fitness experience and quality personal an...

3h ago

Go to Apply

Data Entry Clerk

Robert Half • Oakland, CA • 3h ago

Management & Administrative

Description Job Overview We are looking for a reliable Data Entry Clerk to accurately input, update, and maintain company records and databases. Job Description Enter and update data into internal systems with speed and...

3h ago

Go to Apply

Subscribe to get new jobs sent directly to you
(no charge, cancel anytime)