Regulatory Affairs Manager Life Cycle Management (m/f/d)

REFERENCE NUMBER:

451767/1

MY DUTIES:

-Responsible for leading assigned production transfer projects and other initiatives related to life cycle activities
-Act as a single point of contact for cross-functional project teams, independently providing strategic direction on production transfer projects for RA GDD, driving and monitoring progress and deliverables (timelines+risk)
-Lead the assessment of RA GDD resources (DU, Operations, Regional representatives and COs) required for the assigned
-Coordinate with regulatory associates and with the RA GDD CMC project manager for assigned cross functional projects to deliver aligned regulatory strategy, agreed upon project timelines and consistent regulatory requirements
-Track progress of assigned projects, including timelines, dossier deliveries and resource utilization
-Alert project team and RA GDD management to risks, issues and achievements
-Facilitate communication between regulatory associates and cross functional project team members, support regulatory associates sourcing information and providing team contacts
-Ensure amongst the stakeholders within and external to RA GDD a common understanding and agreement of roles and responsibilities
-Lead or participate in multidisciplinary teams focusing on identifying gaps, escalating concerns and supporting and driving continuous improvement and management initiatives
-Support Lessons Learned sessions and trainings within and external to RA GDD leading to improve strategies and decisions on common regulatory approaches

MY QUALIFICATIONS:

-Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
-Profound experience in Regulatory, product development and/or manufacturing
-Proven expertise in project management
-A good understanding of pharmaceutical technology, product life cycle management and the drug development process
-Proven track record of early recognition of potential regulatory issues, distilling complex situations, sound risk assessment and overcoming hurdles
-Ability to work in cross-functional and international environment.
-Strong team player
-Proven track record of successful risk assessment.
-Advanced interpersonal skills. Strong conflict management skills
-Open communicator
-High level of organizational awareness

MY BENEFITS:

-You will work in an international environment
-Option for extension

ABOUT HAYS:

With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.