Description
Job Title: RA Manager Life Cycle ManagementWe are looking for a regulatory affairs consultant to lead assigned production transfer projects and other initiatives related to life cycle activities such as interacting with experts from RA development units, RA CMC, Operations, Finance, Regional representatives.
Major Activities
* Lead the assessment of RA GDD resources (DU, Operations, Regional representatives and COs) required for the assigned projects.
Coordinate with regulatory associates and with the RA 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.
* Facilitate communication between regulatory associates and cross functional project team members.
* Lead multidisciplinary teams focusing on identifying gaps, escalating concerns and supporting and driving continuous improvement and management initiatives.
Experience required:
Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent.
* Minimum of 8 years 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.
This is 10 months contract and may be extended. Please contact Beata Klecz on for more information
Michael Bailey International is acting as an Employment Business in relation to this vacancy.