The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate’s/applicant’s qualifications, skills, and level of experience as well as the geographical location of the position.

Applicants must be legally authorized to work in the United States. Sponsorship not available.

Our client is seeking a Regulatory Project Management in Foster City, CA/ Remote.

Role Description

• Manages basic department/cross-functional specific programs and/or initiatives.
• Manages basic project/initiative communications and works in partnership with senior-level Project Management to ensure that all stakeholders are fully informed and knowledgeable of project activities and their status.
• Provides Regulatory Project Management support for assigned programs/projects/initiatives; may attend sub-team meetings.
• Fosters effective and productive communication among various Regulatory Affairs groups including Regional Regulatory Leads, Regulatory CMC, Labeling, Advertising and Promotion, Regulatory Operations, Medical Writing, and representatives from other functional areas, as appropriate.
• Identifies and manages critical path activities.
• Supports 1 – 2 Regulatory Projects, including but not limited to cross-reference INDs, original INDs, and simpler RTQs.
• In relation to regulatory submissions, tracks and prepares project information and activities, including minutes, timelines, action items and function-specific deliverables. Ensures integration of project timing, scope and resources.
• Works in partnership with senior-level Project Management and/or Project Lead to ensure timely, efficient and effective meetings and progress on activities between meetings.
• Works in partnership with senior Project Manager and/or Project Lead to execute on deliverables.
• May coordinates basic team operations and communications.
• Works with senior Project Management to generate periodic project team and sub-team updates and assists with preparation of formal presentations as required.
• May implement routine process improvement and optimization initiatives as required.
• May manage sub-projects as assigned.
• Focuses on operational tasks, learns how to manage submissions independently, and starts to develop a strategic mindset.
• Ensures project work complies with established practices, policies and processes and any regulatory or other requirements.

Skills & Requirements

Minimum Education & Experience
• BA/ BS with 5+ years’ relevant project management or scientific experience in the biopharma industry, or 3+ years’ relevant experience with an advanced degree.
• A scientific background is preferred.
• Relevant experience consists of work in a scientific field or equivalent experience with R&D project teams and/or cross-functional project management activities.
• PMP (Project Management Professional) or other PM certification or equivalent is a plus.
Knowledge & Other Requirements
• Knowledge of the drug development process.
• Modest knowledge of regulatory requirements specific to key regions such as the US and EU, and have a general awareness of current global and regional trends in Regulatory Affairs.
• Experience in assisting with multiple projects and flexibly adapting to changing priorities.
• Experience in assisting with project scope, timelines and deliverables.
• Awareness of Agile Methodologies and their application in the R&D biopharma environment.
• Organizational awareness and knowledge of change management with the ability to support senior Project Management in an evolving environment.
• Ability to communicate in a clear and concise manner.
• Ability to support team-oriented, highly-matrixed environment.
• Ability to execute multiple tasks as assigned.
• Must be quality driven individual with strong attention to detail and accuracy.
• Ability to support an inclusive environment of empowered teams who operate with high standards of alignment, trust, accountability, expertise, transparency, and collaboration.
• Knowledge and skill with Microsoft Project, Microsoft Excel and other reporting and tracking tools.

Benefits/Other Compensation

This position is a contract/temporary role where Hays offers you the opportunity to enroll in full medical benefits, dental benefits, vision benefits, 401K and Life Insurance ($20,000 benefit).

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.

Nervous about an upcoming interview? Unsure how to write a new resume?

Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.

Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays’ guiding principles is ‘do the right thing’.
We also believe that actions speak louder than words.
In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us.

In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570.

Drug testing may be required; please contact a recruiter for more information.

#LI-DNI