Global Program Regulatory Manager - Junior

Highly Competitive
  1. Contract
  2. Project Manager
  3. Switzerland
Basel
Posting date: 21 Aug 2019
RA.ML.24966_1566395053

A leading global pharmaceutical company that specialise in the development of biological therapies is advertising a vacancy for a Global Program Regulatory Manager - Junior position. This company is one of the top 10 global pharmaceutical companies that operates in 140 countries worldwide and has market leading products in multiple therapy areas. Based in Switzerland, this is an exciting opportunity to work with an internationally renowned establishment.

Job Responsibilities:

  • Developing regulatory strategies for projects in the company portfolio (both small molecule and biologics programs) assuring regulatory guidance is provided to teams from the time of candidate selection through first in man/POC.
  • Assuring a smooth transition of all programs into the development portfolio, across business franchises in general medicines.
  • Providing global regulatory direction and evaluating regulatory risks/gaps and trade-offs for the overall ED development plan with a focus on efficient global planning for first in human studies. Develop contingency plans for identified risks in the regulatory strategy.
  • Following industry and health authority actions and guidance in novel technologies, such as advanced cell therapies, assuring that scientists and teams have a state-of-the-art understanding of the current regulatory environment in these fast-moving fields, and actively participating in scientific forums to share critical learning.
  • Working with Development DRA leadership and company teams to align project milestones and risk benefit analyses with the goals of assuring a smooth transition from company to development for all programs, both internal and in-licensing opportunities.
  • Driving global approaches to early development strategies, considering novel approaches to timely POC outcomes.
  • Providing regulatory guidance on biomarker strategies.
  • Leading interactions with regulatory consultants for strategic input and challenges, particularly for novel technologies and therapeutic approaches.
  • Providing regulatory input into company-driven licensing activities including technologies and M&A proposals, assuring regulatory risks are identified.
  • Taking regulatory lead on transition teams as ap-propriate.
  • Understanding regulatory compliance/best practice in the organisation, identifying training needs as appropriate training.
  • Assuring an operational understanding of the regulatory process in the Biomedical Research teams, identifying gaps that require training.

Skills and Requirements:

  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Manon Luflade at +02038540586 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-ML1

#RegulatoryAffairs

close