Senior Regulatory Affairs Manager EMEA
An attractive job opportunity has arisen at a leading multinational pharmaceutical company who is seeking a Senior Regulatory Affairs Manager EMEA to work at their Germany site. The company works to develop and change medicine, so if you're looking for a life changing role then this might be for you.
- Prepares (i.e., plans, writes, and reviews) various sections of marketing applications and variations and ensure timely submissions to regulatory agencies.
- Keeps aware t of current EMEA regulatory practices, procedures and changes, as appropriate by project.
- Participates in and/or represents Regulatory Affairs on project teams within defined projects.
- Work with Sales, Marketing and Deployment groups to have a thorough understanding of commercial plans in order to provide insights on the feasibility for market entry.
- Collaborates with customers, distributors or third-party regulatory service providers to gain and maintain marketing approvals.
- Actively participates in the development of regulatory strategies in conjunction with senior RA personnel.
- Assists with publishing or compilation of regulatory submissions.
- Perform regulatory intelligence searches for registration and other regulatory requirements in applicable EU regions, paying attention to changing regulatory landscape and competition.
- Routinely interacts with management regarding regulatory matters.
- Perform other related duties as required.
Skills and Requirements
- Bachelor's degree or equivalent with 5-10 years regulatory affairs experience
- Experience interacting with Competent Authorities; must have knowledge and experience with the German regulatory authority (e.g. PEI)
- Strong communication (oral and written), interpersonal and negotiation skills in English, German (required).
- Must be able to work in a fast-paced environment with demonstrated ability to effectively manage multiple competing tasks and demands.
- Ability to drive projects to completion within deadlines.
- Ability to manage projects and solve problems independently.
- Demonstrated communication skills (interpersonal, written, verbal, listening).
- Demonstrated time management (timelines, schedules, task prioritization).
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 Niklas Kaminski at +44 203 542 8287 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.