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Senior Strategist Clinical Regulatory Affairs (f/m/d)

Senior Strategist Clinical Regulatory Affairs (f/m/d)

Job Title: Senior Strategist Clinical Regulatory Affairs (f/m/d)
Contract Type: Permanent
Location: Munich, Bayern
Industry:
Salary: €90000 - €100000 per annum + + negotiable
Start Date: ASAP
Reference: RA_2020_32_1601560672
Contact Name: Sebastian Gotzler
Contact Email: s.gotzler@sciproglobal.de
Job Published: October 01, 2020 14:57

Job Description

Senior Strategist Clinical Regulatory Affairs (f/m/d) | Munich | Pharma

Do you have the ambition to significantly improve people's health through your work? Do you enjoy developing European and global regulatory strategies for complex theragnostic products? Are you an enthusiastic natural scientist and have a fable for meticulous and super accurate work in the field of regulatory affairs?

If you would like to experience this with a globally oriented, researching pharmaceutical company in the field of oncology, then you have come to the right place!

What will your work as Senior Strategist Clinical Regulatory Affairs involve?

  • Develop and implement global regulatory strategies for complex theragnostic radiopharmaceutical products, including proactive identification of regulatory risks / options and mitigation strategies
  • Collaborate with external contractors and consultants in the execution of clinical regulatory activities
  • Write and/or review of regulatory documents required for filing of NDA/MAAs and IND/CTAs, including but not limited to Modules 2.4 - 2.7, Product Information, responses to the Health Authority questions, clinical study protocols and reports, investigator's brochures, case report forms, informed consent forms and other relevant documents
  • Prepare and/or review briefing documents for Health Authority meetings, Orphan Designations Applications and Paediatric Investigation Plans
  • Contribute to regulatory due diligence of the preclinical and early clinical data in support of early development projects
  • Support development of Target Product Profile for assigned development projects
  • Monitor changes in the regulatory environments and advise on company adaptive responses

What does this position offer you?

  • Type of contract: unlimited & full-time
  • Salary: basic salary + bonus
  • Vacation: 30 days / year
  • Working hours: 40 hours / week
  • Accessibility: on-site parking and very good public transport connections
  • Start date: As soon as possible

What requirements should you have?

  • Successfully completed degree in Live Sciences (for example in Chemistry, Biology, Pharmacy or Medicine)
  • 7+ years of regulatory and drug / biologic development experience
  • 4+ years of experience working in the field of oncology indications; experience with diagnostic radiopharmaceuticals would be an asset
  • Experience in the preparation of regulatory dossiers and submissions to EMA, FDA or other major regulatory authorities; Proven success in global drug regulatory submissions
  • Leading the regulatory activities from early development to commercial launch
  • Ability to work in a hierarchically flat matrix environment
  • Good preclinical and clinical data interpretation / data analysis skills
  • Good management, interpersonal, communication, negotiation and problem-solving skills
  • Fluent in English, both written and spoken; German would be a plus

Information about our client:

Our client is a medium sized company dedicated to the development, production and global supply of innovative diagnostic and therapeutic radionuclides and radiopharmaceuticals. Their portfolio and growing pipeline of targeted treatments in various stages of clinical development addresses a wide rang of cancers.

Are you interested in this position? Then you should apply now! If you would like to receive further or alternative positions, I would also be happy to receive your application!

I look forward to your application!