Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Job Details

Director/Senior Director, Regulatory Affairs - FSS Team Lead - EMEA-145060

Company: PPD
Location: Europe, Middle East & Africa
Reference: 145060
Closing Date: 25 Jun 18
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

Director/Senior Director, Regulatory Affairs – Functional Service Solutions PPD has available an exciting new career opportunity for a Director/Senior Director Regulatory Affairs and head of Regulatory Affairs Functional Services Solutions team.  This is a senior level role working closely with the Regulatory Affairs leadership team, leading our Functional Services Solutions business unit. ...

Requirements:

Director/Senior Director, Regulatory Affairs – Functional Service Solutions

PPD has available an exciting new career opportunity for a Director/Senior Director Regulatory Affairs and head of Regulatory Affairs Functional Services Solutions team. 

This is a senior level role working closely with the Regulatory Affairs leadership team, leading our Functional Services Solutions business unit.  The position will provide opportunity for creativity and innovation, whilst leading and driving the success of your team and the business.  This role is key to the growth of our Functional Services Partnership (FSP) Regulatory Affairs business.

 

In this role, you will:

• Line manage a team currently all based in EMEA.

• Define and direct the business strategy for FSP in Regulatory Affairs, focusing on our technical capabilities,  innovation and flexibility. Serve as liaison to executive management, and liaise with internal functional teams and clients.

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

• Provide project specific strategy, technical expertise and coordination oversight for key clients’ projects.

• Serve as the executive contact for key clients for all issues, including attendance at regulatory authority meetings and other public relation functions.

• Oversee project budgeting/forecasting

• Collaborate with 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.

• Establish appropriate policies and processes . Interpret and recommend modifications to company-wide policies and practices. Develop and take  responsibility for budgets, schedules, and performance standards.

• Interact with senior management, and others concerning matters of significance to the company. Conduct business and technical briefings for senior and top management and for external management and / or representatives.

• Utilise current knowledge and RA experience to project direction of RA environment and client future needs; act as a future-thinker and thought-leader who can make things happen.

• Contribute to other projects and initiatives according to expertise and experience; bring personal subject matter expertise to where it counts.

 

Qualifications

Education and Experience: 

• Bachelor’s degree or equivalent and relevant formal academic / vocational qualification

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 15 years’)

• Strong regulatory background. Experience in Post Approval may be advantageous

• Advanced leadership skills and line management experience

• CRO/Consulting and customer facing experience is preferred

 

 

Knowledge, Skills and Abilities:

• Proven experience in business development activities and networking

• Superior English language communication and negotiation skills, as well as local language where applicable

• Excellent understanding of global/regional/national country requirements and regulatory affairs procedures for clinical trial authorization, licensing and lifecycle management; superior understanding of ICH and other global regulatory guidelines; advanced knowledge of at least one of the regulatory speciality areas: preclinical, clinical, CMC, publishing, etc.

• Advanced understanding of budgeting and forecasting with the ability to interpret data with attention to detail

• Capable of supervising, evaluating, and mentoring departmental personnel

• Capable of driving innovation in developing new ideas related to process improvements and efficiencies

• Excellent organizational, judgment, analytical, decision-making and interpersonal skills to manage complex projects in parallel and manage rapidly changing priorities

• Effective computer skills, including the use of Microsoft (MS) Word, MS Excel, Adobe Acrobat, etc.

• Capable of independently assessing sponsor needs and working with project team members in producing compliant deliverables

• Capable of independently learning new technologies

• Outstanding analytical skills to work on extremely complex problems where analysis of situations or data requires and evaluation of intangible variables

• Capable of effectively acting as a liaison with other departments

• Comfortable with direct and proactive approaching of clients; ability to sell proactively.

• Proven ability to lead and motivate teams.

Apply for this job: Director/Senior Director, Regulatory Affairs - FSS Team Lead - EMEA-145060

Contact Information:

Address:  PPD Cambridge
Granta Park
Great Abington
Cambridge

CB21 6GQ
England
Website:  Visit Our Web Site

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.