Project Manager (Biologics Regulatory)

Biologics Regulatory Project Manager

Randstad Professionals is actively looking for a Biologics Regulatory Project Manager to join their international pharmaceutical client in Basel, Switzerland.

Job description:

The candidate will support the Regulatory Teams (TRTs) in managing programs efficiently and in executing regulatory activities. This candidate is an advocate of the PMO, utilizing best practice methodologies to support TRTs and providing clear communications to the PMO for assessment and trending at the portfolio level. This role builds effective relationships with Technical Regulatory Leads (TRLs), TRT Members, Biologics PMO, Technical Development Teams, Technical Product Teams, and other program stakeholder to ensure visibility to TRT operations and cross-functional alignment of TRT strategy.

RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:

- Support TRTs and TRLs in developing TRT charters, plans, detailed schedules, deliverables lists, status updates, resource requests and program specific communications for individual programs in the regulatory product portfolio including large molecules, devices, antibody drug conjugates
- Provide technical management support to TRTs at any stage of the drug development life cycle (ie clinical/development or post-launch marketed phases)
- Coordinate and facilitate TRT meetings and all aspects of program information management ensuring robust documentation and communications
- Partner with TRLs and site management, facilitating team interactions and mobilizing teams to deliver successfully on the agreed objectives
- Execute project management activities to support products for global market applications and product life cycle activities
- Support issue-specific multi-product impacting regulatory projects to ensure alignment of regulatory strategy and compliance across the Biologics platform
- Provide support to the TRT Program Management Office (PMO) and to the PTR site management on major departmental and cross functional initiatives
- Leverage and continuously improve TRT Program Management Office (PMO) business process and program management methodologies
- Develop and maintain the PMO resource library (templates, tools etc.) and improve it based on use and feedback by the TRTs
- Collaborate with Regulatory Operations and colleagues in PTR and PDR for regulatory submissions as needed
- Train junior PTR colleagues in the principles of Project Management and establish simple project management processes for early stage products.

REQUIRED SKILLS AND QUALIFICATIONS:

- BA/BS in Scientific, Technical, Engineering or Business discipline
- A minimum of 5 years' total work experience with at least 2 or more years' relevant experience in project management within the pharmaceutical/biotech industry with a sound knowledge of drug development Processes
- Project, Program, or Portfolio Management certification is preferred; Knowledge of Portfolio and Program Management methodologies, concepts, techniques and tools is required
- Prior experience managing portfolios in a strategic context is a plus
- PMP Certification preferred
- Prior regulatory experience a plus
- Six Sigma or other OE-related certifications a plus
- Highly Competent in MS Office applications including Excel, Powerpoint, Word, Project, etc.

LEVEL OF EMPLOYMENT: 100 %
START DATE: IMMEDIATE
SERVICE DURATION: 6 MONTHS WITH POSSIBLE EXTENSION TO 1 YEAR
LOCATION: BASEL

If you're up for a new challenge, please don't hesitate to send in your application!

Good to know you

Charlotte