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Job Details

Regulatory Affairs Associate Director-144043

Company: PPD
Location: Europe, Middle East & Africa-UK-England-Cambridge,
Reference: 144043
Closing Date: 25 Mar 18
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

  PPD Regulatory Affairs department has an exciting new career opportunity available.   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. ...

Requirements:

  PPD Regulatory Affairs department has an exciting new career opportunity available.   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.

Main responsibilities include:

• Provides regulatory consulting and strategic advice to internal and external clients

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

• Liaises with PPD globally to support global projects, and ensures quality performance for key/managed projects

• Serve as key clients “Executive” contact person for all issues including attendance at Regulatory Authority meetings and other Public Relation functions

• Manages project budgeting/forecasting

• Assists business development and senior management in pricing and securing new business by making presentations to clients, developing and reviewing bid proposal texts and budgets and conducting contract negotiation through to closure

• Contributes to development & implementation of Global/regional function/plans

 

 

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Qualifications

Education and Experience:

 

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10 years’) or equivalent combination of education, training, & experience

Expertise with ATMP/Gene Therapy, Medical Devices, or Vaccines

Experience in clinical trials, regulatory agency scientific advice meetings and business development is preferred

CRO/Consulting and customer facing experience is preferred

 

 

Knowledge, Skills and Abilities:

English language as well as local language where applicable

Excellent interpersonal skills

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

Effective oral and written communication skills

Excellent 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

 

IndeedPPDGBIE

 

Apply for this job: Regulatory Affairs Associate Director-144043

Contact Information:

Address:  PPD Cambridge
Granta Park
Great Abington
Cambridge

CB21 6GQ
England
Website:  Visit Our Web Site

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