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Manager Clinical Regulatory Affairs (m/w/d)

  • Location: Schwandorf in Bayern
  • Salary: €80000 - €100000 per annum + package negotiable per year
  • Job Type:Permanent

Posted 21 days ago

  • Sector: Pharmaceutical
  • Contact: Marlene Inderhees
  • Contact Email: m.inderhees@sciproglobal.de
  • Expiry Date: 08 February 2023
  • Job Ref: 02_2023_1673275658

Manager Clinical Regulatory Affairs Manager (m/f/x) | Munich | Pharma

Our client, a radiopharmaceutical biotech company, provides patients, physicians and partners with high-precision radiotherapeutics and diagnostics to fight cancer. They are always motivated by their commitment to the best interests of patients, for which high-quality products have been developed, produced, and made globally available. With almost two years of experience in the radiopharmaceutical field and the global supply network, the company aims to fully exploit the great potential of nuclear medicine to help patients live longer and better.

What will your tasks as Manager Clinical Regulatory Affairs be?

  • Develop and implement global regulatory strategies including proactive identification of regulatory risks/options and risk mitigation strategies
  • Write and/or review regulatory documents required for NDA/MAA and IND/CTA submissions
  • Preparation and/or review of briefing documents for health authority meetings
  • Working closely with health authorities and ensuring an optimal relationship between regulatory authorities and the company
  • Assisting with pricing and reimbursement
  • Coordinate with cross-functional teams to complete regulatory submissions by compiling, drafting, editing and reviewing
  • Contributing to regulatory due diligence of preclinical and early clinical data in support of early development projects
  • Responses to health authority questions, clinical study protocols and reports

Your requirements?

  • Degree in Life Sciences (pharmacy, chemistry, biology)
  • At least 5 years of experience in regulatory and drug development, ideally in oncology
  • depth experience of drug regulatory dossiers and submission to EMA, FDA
  • Experience in Authorisation Applications through CP and MRP
  • Professional experience in writing of regulatory documents, product labels (CCDS, EU) and response documents (PIP,PSPs)
  • Proven success in global regulatory submissions

Essential knowledge & skills:

  • Excellent written and communication skills in English
  • Demonstrated teamwork and working in a multidisciplinary matrix setting

What does the position of (Senior) Manager Regulatory Affairs CMC offer you?

  • Salary: base salary depending on individual experience
  • Type of contract: unlimited
  • Holiday: 30 days / year
  • Working hours: 40 hours / week
  • Benefits: company pension scheme according to internal principles, seminars, language courses, health offers, leased bicycles, accident insurance, etc
  • Access: Very good public transport connections
  • Home office: 85%
  • Start date: At the next available date

My contact details:

  • Email: m.inderhees@sciproglobal.de
  • Tel: 0049 (0) 89/26 20 09 25 (direct dial)
  • Xing: https://www.xing.com/profile/Marlene_Inderhees/cv
  • LinkedIn: https://www.linkedin.com/in/marlene-inderhees-376a7a16b/

I look forward to your application!