Purpose of the function

Roles and Responsibilities

• Lead the Regulatory Procedural Management team in the EU and International serving as a link between Regulatory Strategists, and other disciplines in RA (e.g. Labelling, RegOps, Affiliates, CT office) and in R&D and in the business units. 
• Represent EU and International Regulatory Procedural Management in global regulatory and development teams and provide regulatory procedural guidance and operational strategy for assigned projects.
• Plan, lead and manage assigned regulatory submissions during development and life cycle management, in alignment with Regulatory Strategists, to European and other assigned non-EU authorities.
• Determine the required documentation.
• Ensure adherence of regulatory procedural requirements.
• Coordinate preparation of and prepare and author procedural regulatory documents, review regulatory and related documents from a procedural perspective.
• Direct activities required for timely and accurate submissionandwork closely with supporting functions such as Medical Writing, and other disciplines in RA (e.g. Labelling, RA-CMC, RegOps, CT office).
• Support and coordinate HA and internal meetings.
• Work closely with Project Management agreeing delivery timelines, planning and tracking.
• Act as regulatory contact person for authoritiesfor assigned procedures.
• Support internal communications on regulatorystatus for the assigned assets.
• Ensure consistency across projectsand alignment/synergies with the US RPM role.
• Participate in or lead assigned non-project tasks designed to enhance the functionality and processes of RA.
• Keep current with, review and interpret regulatory and scientific regulations, directives, guidelines and initiatives.
• Communicate important changes and trends within RA and other functions when relevant.
• Design and revise SOPs and SOIs if required.
• Mentor/instruct and provide guidance to internal and external (in-)direct reports including consultants and vendors.
• Plan, assign and direct work; manage competing priorities as appropriate.

Education & Experience

• University Degree Degree (Bachelor, Master, State Examination, Diploma) in pharmacy, medicine, life or natural science required
• University Degree Post-doctorate or professional experience in pre-clinical research or clinical development, a TOPRA diploma Preferred or Master (e.g. chartered) in Regulatory Affairs or further pharmaceutical specialization (e.g. “Fachapotheker fuer Arzneimittelinformation”) is preferred
• At least 8 years Working experience in pharmaceutical industry, in Clinical Research Organizations or in a regulatory authority with atleast experience in regulatory affairs with an emphasis on clinical trial applications, regulatory pre-submission and post-approval activitiesand preparation of new Marketing Authorization in Europe (EU and non-EU)
• Experience in paediatric development is preferred
• Experience of working in a European or global regulatory environment and interacting with regulatory authorities

Skills and additional Requirements

• Excellent interpersonal skills.
• Ability to communicate and work across functions effectively in a multinational organization to accomplish results.
• Be “detailed-oriented” with a good oversight, well organized and self-motivated.
• Proven ability to plan, coordinate and lead activities simultaneously on multiple projects.
• High ethical behaviour.
• Understanding of drug development and regulatory processes.
• Ability to interact and communicate effectively with regulatory authorities.
• Excellent written and verbal communication skills in English, German and a third language preferred.