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Regulatory Affairs Life Cycle Manager

Posted on Dec 2, 2019 by Harvey Nash IT Recruitment Switzerland

Basel, Switzerland
Research
Immediate Start
Annual Salary
Contract/Project

For our client in Basel we are looking for a RA Manager Life Cycle Management for a 10 month project.

Place: Basel

Workload: 100%

Duration: 01.01.2020- 31.10.2020

Job Purpose

Responsible for leading assigned production transfer projects and other initiatives related to life cycle activities triggered by the company. 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.

This includes interacting with experts from RA GDD development units, RA GDD CMC, RegCMC BTDM, Operations, Finance, Regional representatives (MoW, LaCan, EU), Policy and Quality Assurance to align a common RA GDD approach to handling production transfer projects and other initiatives from planning, execution to communication and completion

Major Activities

* Single point of contact for assigned cross functional projects as relates to RA GDD providing input on regulatory requirements, timelines, and risks.
* Lead the assessment of RA GDD resources (DU, Operations, Regional representatives and COs) required for the assigned projects. Together with RA GDD Finance, formalize resources required and negotiate Service Level Agreements with NTO for the assigned projects. 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.

Ideal Background

Education:

Minimum:
* Degree in Science (eg Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent.

Desirable:
* Advanced degree in Science (eg Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent.

Languages:
* Fluency in English - written and spoken

Experience:
* 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.
* Strong team player
* Proven track record of successful risk assessment.
* Advanced interpersonal skills. Strong conflict management skills. Open communicator.
* High level of organizational awareness

For more information, please contact:

Anna Chmura (see below)

Reference: 804176456

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