Regulatory manager in Basel

veröffentlicht
Kontakt
Audrey Bisch, Basel Professionals Health Care & Life Sciences
Jobtyp
Contract
jetzt bewerben

job details

veröffentlicht
Ort
Basel, Basel-Stadt
Sektor
Life Sciences
Jobtyp
Contract
Referenznummer
16878
Kontakt
Audrey Bisch, Basel Professionals Health Care & Life Sciences
Telefon
058 201 55 50

Stellenbeschreibung

Do you want to work in a big pharmaceutical company? Do you have experience in regulatory submissions? You should then read the following lines!

 

Our client, based in Basel, is looking for a Regulatory manager for a 12 months contract.

 

 

Your Tasks:

 

 

Major Accountabilities

* Regulatory support of the portfolio transformation team, especially divestments (focus data collection, implementation), production transfers and portfolio rationalization (pruning, deregistration)

* Track progress of assigned projects, including timelines, dossier deliveries, HA approvals. Alert project team and RA GDD management to risks, issues and achievements.

* Facilitate communication between regulatory associates and cross-functional project team members (BD&L, CMC, NTO, legal, RA in the countries).

* Lead or participate in multidisciplinary teams focusing on identifying gaps, escalating concerns and supporting and driving continuous improvement and management initiatives.

* Data/business analytics - driving/reporting performance metrics (methodology, design, tracking)

 

Key Performance Indicators (KPIs)

* Recognized by external and internal RA GDD customers as a trustworthy, competent, and reliable partner with a good overview of the project portfolio and regulatory requirements for production transfers.

* Consistent record of strategies and processes devised and implemented successfully to deal with new developments, and rolled out to departmental staff, reflecting sound risk management and appropriately considering all stakeholder's need.

* Reliable, timely, accurate and proactive communication of general of project specific issues to key stakeholders as appropriate.

 

 

Your Profile:

 

* 5-8 years in Regulatory portfolio transformation activities (divestments, Tech Transfers)

* Minimum Master degree in Life Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent.

* Fluency in English - written and spoken

* Proven expertise in project management.

* A good understanding of pharmaceutical technology (previous CMC experience - as advantage) and product life cycle management.

* Proven record of accomplishment of early recognition of potential regulatory issues, distilling complex situations, sound risk assessment and overcoming hurdles.

* Ability to work in cross-functional (BD&L, CMC, NTO, legal) and international environment.

* Strong team player (communication, collaboration)

* Proven record of accomplishment of successful risk assessment.

* Advanced interpersonal skills. Strong conflict-management skills. Open communicator.

* High level of organizational awareness.

* Data analytics/Data management experience - desired an additional advantage!

 

Do not waste any minutes, apply now!  We are looking forward to receiving your application.

Please note that only candidates with a valid work permit or who are EU/EFTA citizens will be considered.