Regulatory Regional Hub Strategist

Employer
Proclinical Staffing
Location
England, Kent
Salary
Negotiable
Closing date
22 Sep 2020
You need to sign in or create an account to save a job.

An exciting vacancy has opened for Regulatory Regional Hub Strategist in Kent. This is an excellent opportunity to work with one of the most prestigious pharmaceutical establishments in the world.

Job Responsibilities

    Ensure uncompromised compliance and embrace corporate culture. Understand local regulations and trends for assigned markets. Manage initial and post approval submissions for assigned markets. Enable initial and post approval strategy (including timelines) and execution in alignment and partnership with key to ensure a submission ready dossier. Ensure notifications of proposed regulatory changes and approvals are communicated to relevant stakeholders in a timely manner. Author local submission components as needed. Liaise with the manufacturing sites for obtaining supporting documents as needed. Communicate changes to regulatory requirements and update the appropriate system in a timely manner. Work in collaboration across the regulatory organization with stakeholders to deliver efficiencies in regulatory submissions and processes. Contribute to local and regional regulatory initiatives promoting a culture aligned with the company values and which supports compliance and innovation

Skills and Requirements

    Bachelor's degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life science. MSc, MBA or PhD may be an advantage. Experience in regulatory affairs or compliance preferably in human medicines - minimum 5 years of experience. Technically competent to understand CMC submissions, interpret and communicate BoH requirements, and identify potential regulatory risks. Knowledge of drug development practice, rules, regulations and guidelines. Strategic and analytical thinking.


To Apply

In case you have difficulty in applying or if you have any questions, please contact Peter Duvall on 44 203 0789 542 or upload your CV on our website - www.proclinical.com/send-cv

A full job description is available on request.

#LI-PD1

At ProClinical we have one aim: to support life science companies in the many challenges they face while combatting unmet medical need worldwide.

Ageing populations, rare diseases, epidemics and the millions of patients without access to medication are just a few of the pressing issues that life science companies contend with. The industry is under increasing pressure to develop new and innovative ways to save and improve patients’ lives. 

ProClinical’s mission is to support their work by connecting life science companies with the highly skilled professionals they need to continue innovating. 

Internal recruitment and HR teams often struggle to continuously source skilled, experienced professionals to fill highly-specialised and niche roles. ProClinical combines a deep understanding of the industry with extensive candidate networks to provide both a technical and cultural fit for our life science partners.

 

Contact Us
  • Eldon House
  • Eldon Street
  • EC2M 7LS
  • United Kingdom
  • 0800 988 4437
You need to sign in or create an account to save a job.

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert