Senior Manager Regulatory Affairs

Your activities

  • Create and examine documents required for filing of NDA/MAAs and IND/CTAs, including but not limited to Modules 2.4 – 2.7, responses to the Health Authority questions, clinical study protocols and reports, investigator’s brochures, etc.
  • Cooperate with different teams, external consultants and suppliers in the implementation of clinical regulatory activities
  • Proactive identification of regulatory risks / options and mitigation strategies
  • Evaluating regulations,guidelines, procedures etc, providing everything to stakeholders
  • Fulfill regulatory submissions by assembling, drafting, editing and reviewing
  • Development, including implementation of global regulatory strategies for products
  • Close colloboration with with the Health Authorities, preparation and reviewing of briefing documents, inter alia Orphan Designations Applications and Paediatric Investigation Plans

Your background

  • Degree in Life Sciences (for example in Chemistry, Biology, Pharmacy or Medicine)
  • Experience in regulatory and drug / biologic development, ideally in oncology indication
  • Be familiar with preparation of regulatory dossiers and submissions to EMA, FDA or other major regulatory authorities.
  • Practical Knowledge in preparing and submitting New Drug Applications and Marketing Authorisation Applications through Centralized (CP) and Mutual Recognition Procedures (MRP) and National Procedures
  • Expertise in product labels (CCDS, US PI, EU SmPC etc.), writing of regulatory documents, as well as briefing packages for scientific advice meetings, PIP/PSPs etc.
  • Good analysis and interpretation skills with clinical data, good interpersonal skills
  • Fluent in English, both written and spoken

Your benefits

  • Spannende Herausforderungen in einem zukunftsträchtigen und wachsenden Unternehmen
  • Eine offene Arbeitsatmosphäre in einer offenen Unternehmenskultur mit kurzen Kommunikationswegen
  • Ein attraktives Vergütungspaket sowie interessante Weiterentwicklungsmöglichkeiten
Gender note

For reasons of better readability the language forms masculine, feminine and diverse (m/f/*) are used simultaneously. All references to persons apply equally to all genders.

Type of contract

Permanent Position

Industry

Pharmaceuticals

Department

Regulatory Affairs

Location

Munich

Germany

Entry date

asap

Duration

Permanent

Remote

ja

Capacity (FTE)

1

Your contact person
hexagon_portrait_6
Karoline Gutensohn

Executive Recruiting Managerin

Interested?

We are looking forward to your application!

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