Are you an experienced Senior Manager within Regulatory Sciences? Do you have experience within a Pharmaceutical or Biotechnology setting? If so, we would love to hear from you!
The successful candidate will support multiple EU leads by contributing to the development and implementation of EU regional clinical and pre-clinical regulatory strategy for products pre or post MAA approval, in alignment with the EU business strategy.
This is a contract position, offered initially for 12 months working 30 hours per week based in Maidenhead. There are options for hybrid / remote working, as well as an openness to full time applications.
Responsibilities:
* Supporting the EU Regulatory Lead for products pre or post MAA approval
* Leading the planning, coordination and preparation of high-quality regulatory submissions
* Identify and assess regulatory risks associated with assigned projects and overall product development
* Assist in defining strategies to mitigate risks
* Monitor and analyse appropriate regulatory agency activities in areas of interest to the company and assess impact on assigned programs
Experience and skills:
* BA/BS/University degree required (Life/Health Sciences preferred)
* Pharmaceutical/biotechnology industry experience with technical management experience
* Minimum of 2 years in Regulatory Sciences
* Some EU regulatory experience managing submissions preferred
* Experience in interpretation of regulations, guidelines and policy statements
* Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements
* Some direct experience in interfacing with relevant regulatory authorities
* Foster effective, positive interactions with regulatory agencies, and corporate partners
* Ability to work both independently and with minimal direction and within project teams, committees, etc. to attain group goals
* Ability to represent the department in project teams, committees and external meetings
* Demonstrate strong organizational skills, including the ability to prioritise workload
* Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff
* Strong sensitivity for a multicultural/multinational environment
* Experience leading multi disciplinary teams
* Good knowledge and understanding of applicable regulations
Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.
Candidates must be eligible to live and work in the UK.
For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.