Regulatory Affairs Manager - Cambridge-150966

Europe, Middle East & Africa-UK-England-Cambridge
On Application
25 Oct 2018
03 Feb 2019

PPD has a new opportunity for a Regulatory Affairs Manager to join our Regulatory Affairs team based in Cambridge.  This is a fantastic new opportunity to advance your regulatory career in an exciting and fast paced environment.  This is a full-time, office based position in Cambridge, UK.


The purpose of this role is to provide innovative solutions including global regulatory therapeutic area expertise and client interface to provide strategic regulatory intelligence, guidance and regulatory expertise for product development from preclinical through registration and product optimization.



In this role, you will prepare and review regulatory submissions, be involved in providing technical advice to prepare regulatory submissions and provide regulatory strategy advice to internal and external clients.  The role also requires you to provide project-specific strategy, technical expertise and co-ordination oversight for key client’s projects.  You will also have responsibility for quality performance, managing project budgeting/ forecasting, dealing with out of scope activities, and assisting business development in pricing and securing new business.  You will also have the opportunity to guide, train, coach and mentor colleagues.


Education and Experience: 


Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8 years’) or equivalent combination of education, training, & experience

Experience working a client facing role

Experience providing regulatory expertise to clinical trials (including ATMPs), and scientific advice

Project Management experience


Knowledge, Skills and Abilities:


· English language as well as local language where applicable

• Good interpersonal skills

• Familiar with computers and their applications, e.g. Word, Excel, PowerPoint

• Effective oral and written communication skills

• Good organizational and planning skills

• Good negotiation skills

• Ability to work on own initiative

• Proven ability to work effectively in a team environment

• Ability to motivate and integrate teams and teach/mentor team members

• Good knowledge of global / regional / national country requirements / Regulatory Affairs Procedures for Clinical Trial Authorization, licensing, lifecycle management

• Expert knowledge of ICH and other global regulatory guidelines

• In-depth knowledge in one of the specialist areas; preclinical, clinical, or CMC, etc

• Ability to discipline and reward employees and perform timely, effective performance evaluations

• Good judgement and decision-making skills

• Ability to act as liaison with other departments where necessary (i.e. Project Management, Clinical Supplies, QA, Clinical Management, Data Management, Biostatistics, etc)

• Knowledge of budgeting and forecasting


Similar jobs

Similar jobs