EXPIRED – Regulatory Manager / no-321

Location
CH-Basel/Home office
Start
asap
End
31/12/2022
Workload
100 %
All-in / Hour
54 - 60chf/h gross
Total Hours
2.080

Deadline:

Deadline
EXPIRED

 

EXPIRED – Regulatory Manager / no-321

Location
CH-Basel/Home office
Workload
100 %

Start

asap

End

31/12/2022

DEADLINE

Deadline
EXPIRED

  • CH-Basel/Home office
  • CH-Basel/Home officeasap31/12/2022100 % 2.08054 - 60chf/h grossDeadline
    EXPIRED

For our customer located in Basel/Switzerlad we are currently looking for a: Regulatory Manager (m/f/d)

  • Location: Basel
  • Branch: Pharma
  • Duration: 12 months

Tasks & Responsibilities

  • 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)

Must Haves

  • 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!

Did we catch your interest?

The SimplyVision-Team is looking forward to receive your application (Word file is highly appreciated).

Kindly be informed that our customer is located in Switzerland. Therefore only applications from candidates within the EU or candidates holding Swiss work permission are required.

Preferred Interview Dates

  • asap
Files must be less than 5 MB.
Allowed file types: txt rtf pdf doc docx.
If not - no problem - we'll organize one.
More optional Information about your way of finding us
You agree that your data will be used to process your request. Further information and revocation instructions can be found in the privacy policy.


You can apply to this job and others using your online resume. Click the link below to submit your online resume and email your application to this employer.

  • CH-Basel/Home office
  • CH-Basel/Home officeasap31/12/2022100 % 2.08054 - 60chf/h grossDeadline
    EXPIRED

For our customer located in Basel/Switzerlad we are currently looking for a: Regulatory Manager (m/f/d)

  • Location: Basel
  • Branch: Pharma
  • Duration: 12 months

Tasks & Responsibilities

  • 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)

Must Haves

  • 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!

Did we catch your interest?

The SimplyVision-Team is looking forward to receive your application (Word file is highly appreciated).

Kindly be informed that our customer is located in Switzerland. Therefore only applications from candidates within the EU or candidates holding Swiss work permission are required.

Preferred Interview Dates

  • asap
Files must be less than 5 MB.
Allowed file types: txt rtf pdf doc docx.
If not - no problem - we'll organize one.
More optional Information about your way of finding us
You agree that your data will be used to process your request. Further information and revocation instructions can be found in the privacy policy.


You can apply to this job and others using your online resume. Click the link below to submit your online resume and email your application to this employer.

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