Senior Project Manager/Regulatory Affairs Job

SENIOR PROJECT MANAGER-REGULATORY AFFAIRS needed for a CONTRACT opportunity with Yoh's client located in EMERYVILLE, CA.

WHAT YOU'LL BE DOING:

- Manage the Rebranding program activities to assure successful label content development for products within assigned area and be able to assess impact.
- Identify and manage cross-regional rebranding requirements. Consolidate project plans to assess resource, financial, and other gaps for life cycle management.
- Work with functions affected by relabeling implementation to assure that content review/approval procedures are in place for all labeling documents that labeling content is implemented in accordance with established regulatory and/or business timelines.
- Facilitate the review/approval of labeling component artwork and proofs. Prepare and manage the procedures related to these activities to assure compliance with regulatory and quality standards.
- Initiate, plan, execute, and monitor global activities of cross-functional teams to ensure rebranding is completed on schedule, on budget, and meets business, regulatory, and quality requirements.
- Lead project teams responsible for developing and executing on a global rebranding strategy.
- Represent project team at meetings, present project proposals and communicate deviations of project relevant parameters (objective, timeline, budget, and risk) as they occur and ensure access to accurate and up-to-date data to senior leadership and line management.
- Proactively communicate overall project strategy, key issues, and any other critical topics in a timely manner with line management, stakeholders, and senior leadership. Communicate openly and timely, horizontally and vertically in order to achieve transparency of project progress and mediate conflict resolution to achieve and aligned team position.
- Lead team to define and align on project scope based on customer needs and to translate them into traced requirements.
- Drive decision making and problem resolution while managing multiple stakeholders in complex project environments, including global sales and marketing, global marketing, technical operations services, functional heads, and executive management.

WHAT YOU NEED TO BRING TO THE TABLE:

- Bachelors/Masters degree in scientific discipline or equivalent.
- PMP certification or equivalent preferred.
- Company/industry-related knowledge in blood testing products, regulatory affairs, and labeling preferred.
- Minimum of five to nine (5-9) years in product rebranding experience in regulated industry required
- Minimum of five to nine (5-9) years in project management is required. Experience in program management of international and global development teams preferred
- Minimum of five years combined in diagnostics and/or medical device and/or pharmaceutical development preferred.
- Excellent leadership and management skills with experience managing and leading people cross-functionally with varying levels of experience
- Team player with ability to function and influence others in a multi-cultural Matrix environment
- Open communication style with strong verbal and written communication skills.
- Advance project management planning and tracking skills, capable of managing multiple projects with respect to priorities and self-management.

WHAT'S IN IT FOR YOU?

- This is a wonderful opportunity for you to play an integral role at a growing site within one of the largest and most respected pharmaceutical companies in the world.

WHAT ARE YOU WAITING FOR? APPLY NOW!

RECRUITER: Kathy Pavlick

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. Contact us if you are an individual with a disability and require accommodation in the application process.

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