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Regulatory Affairs Manager

Santa Clara, CA 95054

Posted: 02/21/2025 Employment Type: Contract Job Category: Regulatory Affairs Job Number: 617904 Is job remote?: No Country: United States

Job Description

Skills: Demonstrates effective change leadership.; Builds strategic partnerships to further departmental and organizational objectives.; Develops and executes organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills.

Education:
Bachelor's degree and 9+ years of related work experience or an equivalent combination of education and work experience. Advanced degree preferred.

Duties:
1. Recruits, coaches and develops organizational talent.
2. Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
3. Creates an entrepreneurial environment.
4. Provides direction and guidance to exempt specialists and/or supervisory staff who exercise significant latitude and independence in their assignments. May supervise non-exempt employees.
5. Keeps the organization's vision and values at the forefront of decision making and action.
6. Demonstrates effective change leadership.
7. Builds strategic partnerships to further departmental and organizational objectives.
8. Develops and executes organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills.
9. Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations, etc.).
10. Makes decisions regarding work processes or operational plans and schedules in order to achieve department objectives.
11. Develops, monitors and appropriately adjusts the annual budget for department(s).
12. Develop regulatory strategies, approval schedules, and submission standards to achieve departmental and organizational objectives.
13. Assess proposed regulations and communicate new requirements to the organization.

Exempt/Non Exempt: Exempt

Years Experience: 9+

Pay ranges between $48-53/hr based on experience 

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Santa Clara, CA

Ready to take the next step in your career? Explore our job opportunities in the vibrant area around Santa Clara, California. Located in the heart of Silicon Valley, this region offers unparalleled growth opportunities in tech, innovation, and beyond. With attractions like Levi's Stadium, the Santa Clara Convention Center, and the nearby California's Great America theme park, there's always something exciting to do. Indulge in the diverse culinary scene, catch a show at the Triton Museum of Art or the historic Santa Clara Theatre, or cheer for the San Francisco 49ers at Levi's Stadium. Discover why Santa Clara is the perfect place to elevate your career and enjoy a rich blend of culture and charm!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.