Senior Regulatory Affairs Manager
Senior Regulatory Affairs Manager (f / m / d)
Full or Part Time Germany Experienced Professional August 01, 2023 Remote We are looking for
Senior Regulatory Affairs Manager (f / m / d)
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knoell is one of the leading global service providers in offering regulatory registration, clinical development and product development support to clients.
Our team of scientific and regulatory experts and extensive network of partners ensures that all the different regulatory requirements are right from the project outset to support our client’s global business.
People are at the heart of our family-owned business and our values guide the way to our success. Team spirit and mutual support are very important to us.
Our culture is characterised by strong international co-operation, can-do attitude, focus on quality and a growth mindset.
Our strength is to be where it matters - think globally, act locally!
YOUR TASKS
- Registration of plant protection products used in biocontrol and their respective active substances (e.g., microorganisms, plant extracts, semiochemicals), according to the EU regulatory framework Regulation (EC) 1107 / 2009
- Preparation and coordination of EU SANCO dossiers for the approval and / or renewal of biocontrol active substances in the EU and associated countries
- Preparation and coordination of dRRs for the authorization of biocontrol plant protection products in the EU
- Participation in Pre-Submission Meetings with Rapporteur Member States authorities in Europe
- Post-submission support
- Development of registration strategies
- Build-up, maintain and share practical knowledge in a growing, strongly team-oriented working group
- Mentoring of less experienced colleagues
- Giving seminars on the registration of biocontrol for knoell colleagues and key clients
- Conference participation as speaker
- Networking and Acquisition of new clients
- Build-up and maintaining of contacts to relevant authorities all over Europe
- Build-up and maintaining of contacts to key clients globally
YOUR PROFILE
- PhD in microbiology or molecular biology or microbial ecology or microbial biochemistry or biotechnology or genetics or biology or chemistry or any other field relevant for biocontrol
- At least 5 years of relevant experience in EU regulatory processes for biocontrol products and active substances
- Full practical understanding of data requirements for registration of biocontrol products and active substances in Europe
- Good interpersonal skills and the ability to manage complex projects
- Excellent communication and presentation skills
- Excellent language skills in English (spoken and written); additional language skills would be an asset
We look forward to receiving your application!
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