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Regulatory Affairs Manager

We are looking for a regulatory professional with leadership skills who is interested in growing career in a one of the top medical device company!

  • Work type: full-time
  • Salary: by agreement
  • Region: Praha
  • Required language: English (C1)
  • Suitable for graduates: no
  • Reference num.: A6367
Radoslava Bajtošová

Radoslava Bajtošová

777 900 477 radoslava.bajtosova@goodcall.eu

What is it all about?

Managment Responsibilities:
  • develop and execute regulatory plans for complex projects including new products and maintenance of licenses for existing marketing authorizations
  • maintain and develop appropriate positive contact with regulatory government officials
  • act as a consultant in RA and Pharmacovigilance contractual matters
  • manage, facilitate and participate in due diligence processes in the region
  • monitor the budget for the region of responsibility, in liaison with business development, QA, manufacturing, marketing and business functions.

Regulatory Compliance
  • ensure local compliance with company ´s policies and procedures in compliance with the requirements of EU, national laws and regulations
  • implement and maintain a documentation system, covering following documents: registration licenses tracking, collection of requirements for registration, medical devices, labeling, pharmacovigilance, original approval letters / documents, documents verifying conditional approval for all unregistered products, re-registration deadlines and requirements, approval of labeling and advertising materials, permits for clinical trials
  • administer regulatory submissions related to medicinal products
  • approve labeling and advertising materials related to products distributed in the Czech Republic

Pharmacovigilance compliance:
  • to act as a local contact for local regulatory authorities regarding Pharmacovigilance
  • to set up an efficient Pharmacovigilance system for medicinal products
  • to collect, process and follow-up on all local ADRs from all sources according to SOPs and forwards information as per local/regional procedure

Who are you?

  • university degree in pharmacy, chemistry, life sciences or medicine
  • minimum 5 years of professional experience in regulatory
  • proven leadership skills
  • good interpersonal skills
  • English speaking
  • ability to become a business partner

Why is this position attractive?

  • opportunity to work in one of the top medical device company
  • young and dynamic environment
  • a lots of opportunities to participate at sport and charity events
  • great company benefits
  • a chance to grow your career on regional level

Not your dream job?

Check out some more ideas on our Careers Page or download our app to see every job available HERE.

  • Work type: full-time
  • Salary: by agreement
  • Region: Praha
  • Required language: English (C1)
  • Suitable for graduates: no
  • Reference num.: A6367

Contact

Radoslava Bajtošová

Radoslava Bajtošová

777 900 477 radoslava.bajtosova@goodcall.eu
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