Consultant, Regulatory Sciences (m/f/x) Job at Berlin
ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.
The Regulatory Consultant will be working on projects varying from Pharmaceutical, Biotechnology and Medical Device companies and will be dealing with challenging and diverse tasks that will require a result and client orientated mindset as well as excellent interpersonal skills. At the same time, the Consultant will have the opportunity to actively participate in the company’s continued development. The work may include, but is not limited to:
Preparation and submission of marketing authorisation applications and notification of variations including processing of deficiency letters for human medicinal products.
Advise customers on issues relating to the marketing authorisation of medicinal products.
Communication with authorities.
Support clients as regulatory project manager.
Regulatory eCTD publishing und submissions (e.g. MAA, variation, PIP and AMSF in EU, CH, UK and US).
University degree in pharmacy, biology, veterinary or human medicine.
Experience in the tasks mentioned above, especially within the EU and ideally CH.
Ideally, good knowledge of MS project.
Ideally, experience with product information texts or review of promotional material.
Ability to deliver high quality work.
A positive attitude and ability to work well in a team.
Ability to work independently, take initiative and make decisions based on company policies.
Ability to work on multiple projects simultaneously, prioritize and meet project deadlines.
Strong communication skills and work with all levels of the company.
Well organized and ability to pay attention to details.
Excellent German and English skills (spoken and written).
All candidates must be legally eligible to work in Germany.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
About the Company
Company Location: Berlin