Description
Regulatory Affairs Manager - EMEA - Skin CareThis is an exciting time for a very large pharmaceutical company to broaden their team and offer an excellent new opportunity. As some of you may or may not know but there has been changes within the regulatory affairs industry and it is my job to ensure that none of my candidates are suffering in the job market. I am happy to advertise an excellent opportunity for all regulatory affairs candidates who are looking to step up in their career.
Senior Regulatory Affairs Executive
Main duties and responsibilities:
- Regulatory support for new product initiatives and for existing portfolio:
- Contribute to the development of EAME regulatory strategies for OTC products under responsibilities to meet business needs, in line with global strategies and taking into consideration local specificities.
- Execute regulatory activities in support of those EAME OTC status brands.
- Align on project timings, partner with the appropriate stakeholders such as Medical Affairs, project managers, Marketing, Legal, to develop plans in support of brand and project objectives.
- Compile local regulatory feedbacks and prepare multi country packages for products registered via MRPs (Mutual Recognition Procedures) or DCPs (Decentralized Procedures).
- Identify documentation requirements for submission packages; work with J&J cross functional partners to provide core documentations for the package and with J&J local market contacts to generate local documents.
- Ensure that standards and timelines are met.
- Ensure maintenance of adequate records of regulatory activities directly or indirectlyQualifications
Qualifications:
- A Life Science Degree or equivalent qualification with experience in European regulatory Affairs is essential
- A knowledge of OTC, pharmaceutical and/or consumer products technology is also required
- Ability to think analytically, and to appraise technical data for compliance and regulatory submissions
- Well organized, creative, innovative, self-motivated, thorough and flexible, accountability and ownership
- Strong team player; ability to be involved in multi-disciplinary teams
- Excellent communication skills with internal and external influencing skills; English fluent (speaking and writing)
- Displays high ethical standards
- Latifah Khan.
- I am looking forward to hearing back from you.
If this is something you would consider then do feel free to either apply online with us at real staffing or send me an email or call in confidence to L.khan(a)realstaffing.com - .