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Junior Regional Regulatory Specialist

vor 2 Wochen

Frankfurt Am Main, 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 post-approval 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 cross-functional 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