Senior Manager Regulatory Operations

Proclinical is working with a development consultancy that specialises in Regulatory Affairs, Quality Management & Compliance and Pharmacovigilance, Epidemiology & Risk Management worldwide. This established global consultancy is seeking a Senior Manager Regulatory Operations to be based in Berlin, Germany on a permanent basis.

Job Responsibilties:

• Preparation of electronic applications in particular in the eCTD format for approval according to the requirements of the relevant authorities (Europe, USA, etc.) including preparation of proposals, project planning and tracking
• Coordination, creation, compilation and validation of electronic submissions
• Acting as Regulatory Operations Lead for global submission projects, such as MAAs, NDA etc. including definition of eCTD strategy, coordination of involved publishers from various company sites, budget and resource monitoring as well as eCTD validation and quality control
• Project management for Regulatory Operations projects, including communication with clients and authorities
• Support consulting for clients concerning implementation and optimisation of electronic submissions and document management and regulatory information management systems
• Ensure the consistency, integrity and correctness of the data in the regulatory IT systems and quality assurance (e.g. preparation of SOPs and WIs and corresponding training)
• Support validation and maintenance of docuBridge and other software specific to Regulatory Operations

Skills and Requirements:

• Degree in Life Sciences
• At least 5 year of professional experience
• Proven experience in evaluation, preparation and compilation of quality dossiers in all required formats and/or experience in regulatory processes (registration procedures, renewals, variation procedures) with special emphasis on Regulatory Operations aspects
• Professional experience in the area of electronic submissions, esp. eCTD and related topics
• Capability of supervision, prioritization and processing of parallel projects and tasks
• Project management experience, preferably in international project teams
• Analytical thinking; seeks out diverse ideas, opinions, and insights and applies them in workplace
• Connects and relates well with people who think and act differently than oneself

To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Herman Baer at h.baer@Proclinical.de or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.