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Natural Scientist as Regulatory Affairs Apecialist (m/f)

Biopharma Excellence is a biopharmaceutical consulting company that supports locally and globally acting
companies from start-up to TOP20 pharma. We provide unique expertise and services to pharmaceutical companies
to successfully develop their biopharmaceutical drug candidates from early stage to approval and beyond.
We expand our team and look for unique biopharmaceutical experts for our office in Munich.
Specifically we are looking for

RegulatoRy affaiRs specialist (m/f)

We need you if you have worked on biopharmaceutical-related projects where you provided the regulatory strategy, gained experience in interactions with agencies and have supported regulatory submissions. Preferentially you have five to eight years of experience from practical involvement into various projects in this field.
A high percentage of our projects deal with strategic regulatory questions, with agency interaction and client advice on the best path forward. You will be involved into these projects and work closely with the Founders of the company and the Principal Consultants. Apart of your know-how in biopharmaceutical-related regulatory affairs we expect proven communication skills in the dialogue with internal and external stakeholders and established technical writing skills.
Your Profile:
  • Solid know-how in European regulatory affairs, other region-related know-how a plus
  • Specific experience in biopharmaceutical-related regulatory affairs
  • Contribution to regulatory dossier preparations such as IMPD, IND or MAA, BLA
  • Excellent scientific/technical writing skills
  • Experience in the procedures for agency interactions
  • Experience in the establishment of regulatory strategies
  • Solid understanding of the unique scientific features of biopharmaceuticals
  • Demonstrated ability to coordinate and interface effectively within cross-functional groups
  • Excellent team-player
  • Very good organizational and communication skills
  • Fluent English language, German language skills a plus
To fill this position successfully you have a PhD in natural sciences like Biotechnology, Biology, Biochemistry, Pharmacy, and minimum of five to eight years in in the pharma or biotech environment.
We offer:
  • A spectrum of highly interesting projects which are all unique and at the forefront of the current state-of-the art of science and development of novel biopharmaceuticals
  • Work with a team of internationally renowned experts in their field
  • Regular exposure to external stakeholders such as clients and agencies in all parts of the world
  • Challenging responsibilities and room for creativity
  • Cross-cultural working environment
Applications (in English) should contain the following documents:
  • A detailed curriculum vitae
  • Motivation letter
  • List of publications if applicable
  • Description of past experience and future interests
  • Name and addresses of three referees
We look forward to receive your electronic application with reference to “Regulatory affairs” via
info@biopharma-excellence.com. Please specify your salary expectations.
Contact: Mrs Sabine Kistner
Biopharma Excellence GbR
c/o Munich Technology Center
Agnes-Pockels-Bogen 1
80992 Munich, Germany
Phone : +49 (0)89 55050890
www.biopharma-excellence.com
While applying for the job please refer on jobvector
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