Company: TEC Group International
Closing Date: 04 Nov 16
Type: Full Time
Salary (£): 60,000 - 80,000
To apply for this position please contact Sam Murphy Senior Consultant at the TEC Group international - 0208 544 23 24 / firstname.lastname@example.org TEC Group International offers a referral reward for this particular positions. If you refer a candidate that completes the hiring process successfully we will reward you £500!
TEC Group International is currently partnered with a global CRO based in the UK. We are running an executive search for a Regulatory manager with expertise in the clinical trial applications and strategies. The Clinical Trial Regulatory Manager will be key in developing and implementing regulatory strategies for the submission of applications for clinical trials for studies executed by CPWW on behalf of the company’s clients. This position offers some home working opportunities and a maximum of 20% travel per year.
The incumbent will prepare regulatory submissions for the competent authorities and ethics committees in Europe and more. The position will include client and competent authority liaison, and requires high-level technical knowledge, and excellent verbal and written communication skills. The position will include the management of regulatory professionals, external contractors and support personnel for one or more local affiliate offices. The position will have three direct reports so a line management background is preferred.
Job Duties and Responsibilities:
· Be responsible for the preparation and submission of initial CTA (Clinical Trial application) and CTA amendments/notifications to Competent Authorities (CA) in Europe and other regions as needed. Work may be performed directly or through other members of the regulatory affairs group.
Be responsible for initial Ethics Committee (EC) submissions and amendments/notifications in Europe and other regions, as needed. Work may be performed directly or through other members of the RSD.
Act as Regulatory Lead for one or more clinical projects. Participate on project teams directly and/or assign members of the RSD to project teams.
Manage one or more local affiliate regulatory affairs teams, whose primary responsibility is the provision of CA and EC submissions for full-service clinical projects and/or RSD projects.
Provide strategic and operational regulatory guidance to internal project teams, other members of RSD, and clients regarding the European clinical trial application process (CA and EC).
Participate in RFI/RFP processes, bid defences, initial business development meetings with prospective clients, proposal development, and other business development activities as requested.
Perform additional regulatory tasks that fall within training and experience; e.g. IMPD preparation.
Demonstrate job flexibility as requested by RSD management.
Directly supervise one or more local affiliate-based group(s) of regulatory professionals, contractors and support staff who are responsible for the preparation of European CA and EC applications. The Regulatory Senior Manager carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities may include interviewing, hiring and training employees; and planning, assigning and managing work undertaken by self or through subordinates.
Minimum of BS or BA degree in life sciences, Pharmacist, MSc or Doctorate in sciences preferred.
Minimum of 3-5 years in regulatory affairs (drug experience required with additional device and biologic regulatory submission experience a plus).
Experience and understanding of pharmaceutical manufacturing and/or clinical project management an advantage.
Current comprehensive experience in CA and EC applications in Europe is essential.
Experience in providing contracted regulatory services in support of global trials in a CRO preferred.
Experience managing regulatory professionals and support staff responsible for CTA and EC submissions preferred.
Analytical – Synthesizes complex or diverse information.
Problem solving – Identifies and resolves problems in a timely manner and gathers and analyses information skilfully.
Oral Communication – Speaks clearly and persuasively in positive or negative situations; demonstrates group presentation skills and conducts productive meetings.
Quality Management – Looks for ways to improve and promote quality and demonstrates accuracy and thoroughness.
Judgment – Displays willingness to make decisions, exhibits sound and accurate judgment and makes timely decisions.
Planning/Organizing – Prioritizes and plans work activities, uses time efficiently and develops realistic action plans. Demonstrates flexibility and willingness to learn new skills that are relevant to the position.
Safety and Security – Observes safety and security procedures and uses equipment and materials properly.
Windows XP; proficient in MS Word, Excel, Power point.
Experienced in utilizing regulatory intelligence databases.
Excellent organizational skills.
Exceptional written and oral communication skills.
Dowgate Hill House, 14-16 Dowgate Hill, London
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