Manager Regulatory Affairs (m/f/x) | Frankfurt | Consumer Health Care
In this role, you will be acting as the regulatory representative for specific EU initiatives as well as strategic business partner with focus on medicines in Europe. You will be joining a large, complex, matrix organization reporting to the Director Regulatory Affairs for Personal Healthcare.
What will your tasks as "Manager Regulatory Affairs (m/f/x)" be?
- Determine the regulatory strategies to support new initiatives or protect current business/formulations in the market and defining GTM IMPs.
- You manage all regulatory activities needed to obtain and maintain Marketing Authorizations (MAs) and other authorizations for medicines according to EU and local (Germany and Austria) regulations, guidelines, practices, etc.
- Support regulatory life cycle management activities and timely responses to authorities' inquiries.
- Ensure full compliance with national/ European regulations, Company standards, internal requirements and SOPs (Standard Operating Procedures) of all marketed products.
- Prepare or review the regulatory strategy for product registration/maintenance in cooperation with Regional RA team.
- Cooperate with the local and European marketing team in preparation of new launches and any new initiative of the portfolio under your responsibility.
- Coordinate and implement change control processes and continuously track and maintain the CMC submission and approval status.
- Ensure labelling compliance by updating national product information as well as for up to date records in all internal systems under your responsibility.
Your requirements as "Manager Regulatory Affairs (m/f/x)"?
- University degree in pharmacy or related scientific discipline; PhD will be an advantage
- 3+ years' experience in a hands-on Regulatory Affairs role for either pharmaceuticals, OTC, foods, consumer health care or cosmetics
- Experience in registration or marketing authorization of medicinal products and its life-cycle-management in EU countries (Germany, Austria and others)
- Business fluent German and English communication skills (oral and written);
- Excellent communication skills, flexibility and perseverance as well as strong intercultural competencies
Information about our client :
Our client was founded over 150 years ago and has developed into the world's leading consumer goods company with a portfolio including some of the most trusted brands on the market. Their product portfolio includes 60+ individual brands with one of them being "Personal Health Care", where this position will be located. The client is operating in more than 100 countries worldwide and has almost 100.000 employees.
I look forward to your application!