Senior Regulatory Affairs Manager

Project-ID: 1328

Your activities

  • Management and supervision of  Regulatory Operations systems (e.g. Veeva)
  • Working with several departments (e.g. Clinical and CMC Regulatory Affairs) and cross-functional teams
  • Plan and taking care of the timely submission of all regulatory applications to international health authorities (e.g. IND, NDA, MAA)
  • Track regulatory submissions within RIM system (incl. publishing of electronic regulatory applications, mainly in the eCTD format)
  • Serve as the primary point of contact for regulatory publishing activities
  • Responsibility for the formatting and completeness of the documents
  • Preparation of guidance of regulations for publication in the eCTD Formatting of applications, contact person for problems related to publication
  • Identify potential risks to submission plans and create mitigation strategies
  • Monitoring global and national regulations and guidelines and adapting submission specifications (focus on FDA, EMA, Health Canada, and ICH)
  • Responsible for the regulatory operations tools (e.g. SharePoint) and for the publication of documents
  • Promote the ongoing set-up of a new RIM system (including system configuration, data migration, etc.)
  • Archiving of health authority communication
  • Follow-up of questions and commitments
  • Taking over the task as RIM administrator incl. training of tool users
  • Develop internal process documentation, including SOPs, work instructions
  • Report to Regulatory Leads

Your background

  • Completion of a science degree (“nice to have”: additional training in drug regulatory affairs
  • Very good experience within the field of regulatory (publishing and submissions in the eCTD format)
  • Knowledge of Veeva Vault (must have)
  • Advanced knowledge of regulations and guidelines (EMA, FDA, and ICH)
  • Very good German (not mandatory) and English skills
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

Industry

Pharmaceuticals

Department

Regulatory Affairs

Location

Remote

Germany

Entry date

ASAP

Duration

Permanent

Remote

ja

Capacity (FTE)

1

Your contact person
KGU_neu
Karoline Gutensohn

Senior Recruitment Managerin

Interested?

We are looking forward to your application!

To apply, simply fill out the contact form below and attach your resume.

Your CV