Senior Manager, International Regulatory Affairs - Permanent role
Bio-pharmaceutical company based Berkshire
Our client has a single goal - to develop innovative ways of using the immune system to prevent or treat life threatening diseases including cancers, infectious diseases and autoimmune disorders. A small to medium sized bio-pharmaceutical company, my client has successfully grown internationally by acquisition and is now looking to add to the UK team, which is based in Wokingham, Berkshire.
Located within a modern business park, our clients offices have ample free parking and are within easy access of major transport links. Focus on their staff as individuals allow our client to attract and retain the best staff. The atmosphere is friendly on site and staff are compensated with a generous package to include base salary, bonus, pension and healthcare.
Job Summary
Growth has enabled our client to expand their UK Regulatory Affairs team and they are delighted to have an opening for a Senior Manager to join them on a permanent basis. To be successful in this role, the selected candidate will have considerable experience in clinical trial applications, providing strategic support to project teams to allow for^successful project delivery. This is a global role and experience in working across EU, US and Asian markets would be advantageous. This is a role that will provide an excellent opportunity to roll up your sleeves and get stuck in. Working in a small^team, you will have plenty of opportunity to develop your skills and lead others as the team develops further. You will be responsible for all regulatory activities, ranging from planning to final submissions and great communication skills will allow for effective relationship building with both key stakeholders and regulatory agencies.
Essential Skills & Qualification
- A life science degree
- Experience in Regulatory Affairs within a biotechnology or biopharmaceutical environment, preferably within a SME or CRO providing services to SMEs
- A keen interest in, and enjoyment of the challenges of, vaccine/biologics product development from Phase I to licensure
- An in-depth understanding of the regulatory requirements for vaccine/biologics product development in the EU, USA and Asia
- Experience of interacting with Regulatory Authorities at all stages of product development to market authorisation and post-licensure
Supplementary Requirements:
Software Competence: MS Office, EDMS
Valid Driving License: Not Required
Working Language(s): English
Requirement for Business Travel: No - Occasional travel may be required
Flexible Working Hours: To be confirmed
Employment Information:
Employer: Pharmaceutical Company
Employment Type: Permanent
Hours: Full time
Location:UK;Office Based access near M3/M4
Plan Start Date: Negotiable
Employer Benefits:
Company Pension, Private Healthcare, Bonus, Gym allowance
Keywords:
Registration, Regulatory Affairs, MAA, Expert Reports, Clinical Trial Applications, CTA, Dossier, Regulatory Agency, Documentum
Assigned Consultant: Kirsty Clark at CSL Recruitment on 01932 234 681
Please feel free to call for a detailed Job Description or additional information
Applications are reviewed within 24hrs, applicants will only receive feedback if they demonstrate the skills the role requires in their application. The role may be remarketed; if you applied for this role previously and were unsuccessful you will not receive a response. We request that non EU Nationals include evidence of right to work in the country concerned with their application to be considered. Do supply supplementary information on required location, notice period and expected salary/day rate if you are a new candidate.