Junior Regional Regulatory Specialist

Vor 6 Tagen

Frankfurt am Main, Hessen, Deutschland BI International GmbH Vollzeit

The Position:


Step into the shoes of a Junior Regulatory Specialist, where you'll become the mastermind behind the orchestration and execution of regional regulatory documents on an as-needed basis.

You'll find yourself at the heart of global and local interactions, nurturing harmony and collaboration like a true diplomat.


But that's not all You'll also dive headfirst into a myriad of tasks related to our submissions, making every day a new adventure.

This role is the perfect intersection of administrative precision and international teamwork.

Seize this unique opportunity to sharpen your regulatory skills and make a global impact. Your journey towards becoming a regulatory virtuoso starts here

This position is limited for 2 years.

Tasks & responsibilities:

  • As a Junior Regional Regulatory Specialist, you will manage document legalization for Marketing Authorization Applications and postapproval changes, collaborating with the Regulatory Lead, Legal Department, notary, and authorities.
  • In addition, you will consolidate feedback of (R)OPU RA on legalization requirements under consideration of cost and lead time aspects as well as developing signatory process.
  • Moreover, you will develop and provide Certificate of Pharmaceutical Products (CPP), registration samples as well as legalization and notarization concepts and operation.
  • With your expertise, you will assist Regional Regulatory Leads with regional regulatory tasks, including CPPs, registration samples, and legalization topics, proactively consulting with all ROPUs and OPUs.
  • Finally, you will act as an interface & contact partner for GRA functions in ROPUs and OPUs in EM, Global RA and other crossfunctional stakeholders for product and project related regulatory activities for the product(s), in collaboration with the Regional Regulatory Leads EM.

Requirements:

  • Bachelor's degree, preferably in life sciences or equivalent professional experience
  • First pharmaceutical industry experience in Regulatory Affairs or related disciplines is of advantage
  • Ability to work under tight timelines and juggle several tasks in parallel
  • Ability and willingness to continuously learn, adapt to a changing environment and improve efficiency
  • Understanding of different cultures and their impact Fluency in both written and spoken English and German is a prerequisite for this role

Ready to contact us?:

If you have any questions about the job posting or process - please contact our HR Direct Team,

Recruitment process:

Step 2:
Virtual meeting in the period from mid till end of month

Step 3:
On-site interviews beginning of month OR date

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