Regs Affairs Manager - Berlin - Pharma

Location
Berlin
Salary
Negotiable
Posted
Jan 07, 2021
Closes
Feb 06, 2021
Ref
DW.5843958903896t508
Contact
Daniel Watson
Organization Type
Clinical Practice
Contract Type
Contract/Freelance
Hours
Full Time

NonStop are looking to speak with Regulatory Professionals, interested to work in Berlin , we currently have an opportunity for an on at least a 12 month contract, with one of the major players of the industry. Currently they are gaining traction in the market as the one to watch allowing you to gain huge exposure with a recognised name, giving yourself future opportunities for growth.

Scope and tasks:

  • Responsibility for applying for and maintaining approvals, approved in the national, MRP and DCP procedures (including application, variations, PSUR submission, PSURs / PBRERs and risk management plans, etc.)
  • Processing of all national processes in the CP
  • Development of strategic inputs for all products
  • Contact person for national approval and supervisory authorities, etc. a. Answering letters of deficiency, queries or calls
  • Translation, creation and updating of SmPCs, technical and usage information and labelling, training materials and mandatory texts in accordance with national / European regulations and their approval (in close cooperation with Global and European RegAffairs, PV, medicine, marketing.

Experience:

  • At least 3 years of professional experience in regulatory affairs in a pharmaceutical company

Key skills, skills and competencies

  • Knowledge of German on a native level and very good knowledge of English
  • Excellent knowledge of the national legal bases for human medicinal products (AMG, HWG) and the other European bases and guidelines
  • Scientific knowledge of the clinical development and approval of drugs and medical devices
  • Good knowledge of dossier preparation; familiar with eCTD modules
  • Basic product knowledge including basic medical knowledge about drugs

Call me Daniel Watson at NonStop Recruitment now for a confidential conversation. Contact me on D.Watson@nonstop-recruitment.com or +41 435 080 817, please send your CV in word format OR if this does not sound like the opportunity for you, but you are a clinical research professional within the pharmaceutical, medical device or biotech industry, please feel free to get in touch, to see other opportunities we may have within this field.

NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.

Apply for Regs Affairs Manager - Berlin - Pharma

Already uploaded your resume? Sign in to apply instantly

Apply

Upload from your computer

Or import from cloud storage

Your Resume must be a .doc, .pdf, .docx, .rtf, and no bigger than 1Mb


4000 characters left

Marketing Communication

We'd love to send you information about Jobs and Services from Diversity in Research by email.

All emails will contain a link in the footer to enable you to unsubscribe at any time.


When you apply for a job we will send your application to the named recruiter, who may contact you. By applying for a job listed on Diversity in Research you agree to our terms and conditions and privacy policy. You should never be required to provide bank account details. If you are, please email us.

Similar jobs

Similar jobs