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Job Details

Senior Regulatory Affairs Manager-145061

Company: PPD
Location: Europe, Middle East & Africa-UK-England-Cambridge,
Reference: 145061
Closing Date: 22 Jun 18
Type: Full Time
Salary (£): On Application

Job Summary:

PPD has a new opportunity for a Senior Regulatory Affairs Manager to join our our Regulatory Affairs department.  This is a fantastic new opportunity to advance your regulatory career in an exciting and fast paced environment. ...


PPD has a new opportunity for a Senior Regulatory Affairs Manager to join our our Regulatory Affairs department.  This is a fantastic new opportunity to advance your regulatory career in an exciting and fast paced environment.

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. Provides the country/regional regulatory intelligence network and the strategic regulatory authority relationship network, advisers to SIA, and the newly established operational FLEX units, as well as any local regulatory delivery if required.

Major Responsibilities


-Prepares and review regulatory submissions

-Reviews and provide technical advice to prepare regulatory submissions

-Provides regulatory strategy advice to internal and external clients

-Provides project-specific GRA strategy, technical expertise and co-ordination oversight for key client’s projects

-Ensures quality performance for key/managed projects

-Manages project budgeting/ forecasting

-Assists in identifying and recognizing out of scope activities in a contract in a timely manner and liaises with C&PD to follow through on all aspects of contract modification

-Assists business development in pricing and securing new business by making presentations to clients, developing proposal texts and budgets in collaboration with Proposal & Contracts Development

-Responsible for the hiring of GRA personnel

-Provides guidance, training, coaching and mentorship to personnel in GRA

-Provides PPD staff with up-to-date legislation and guidance as it becomes available

-Ensures compliance with relevant organizational and GRA Standard Operating Procedures and Working Practice Documents

-Participates as required in project Launch Meetings, Review Meetings and Project Team meetings




Education and Experience: 

Previous experience that provides the knowledge, skills, and abilities to perform the job or equivalent combination of education, training, & experience

An excellent regulatory background and global knowledge

Strong project management skills

Experience in a CRO/consulting background is desirable

Business Development experience preferred

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

• 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

• Mental skills required in areas of: numeracy, language, analytical, investigative, verbal & written communication, customer contact, attention to detail, multiple project handling, reading and interpretation of data 




Apply for this job: Senior Regulatory Affairs Manager-145061

Contact Information:

Address:  PPD Cambridge
Granta Park
Great Abington

CB21 6GQ
Website:  Visit Our Web Site

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