Specialist Regulatory Affairs

vor 6 Monaten

Munich, Deutschland BAXTER Vollzeit

**This is where you save and sustain lives**

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

For our **Country** **Quality Assurance & Regulatory Affairs Team**, we are currently hiring a

**Specialist Regulatory Affairs (f/m/d) for the DACH-cluster**

based in Unterschleißheim, near Munich (hybrid option).

**Summary**:
The Specialist Regulatory Affairs (f/m/d) DACH cluster is part of the DACH CQA and RA organization and is responsible to ensure that the following processes are maintained in Germany, Austria and Switzerland
- Ensure compliance to regulations (Baxter Corporate Quality Manual, EN ISO 9001, EN ISO 13485, GMP, GDP and country specific requirements)
- Ensure establishment and maintenance of required licenses (e.g. GDP, Wholesaler)
- Ensuring contact with Competent Authorities
- Ensuring that appropriate contacts with other support functions like Pharmacovigilance, W&D, Technical Service, Businesses and Distributors are maintained
- Ensuring that processes and procedures related to the Falsified Medicines Directive (FMD) are in place locally
- Corporate Quality Systems implementation including local requirements to CQA and distribution
- Support of regulatory strategies, obtaining and maintaining of marketing authorizations for product(s) and communication of general regulatory requirements in support of licensing of Baxter’s products

**Essential Duties and Responsibilities**:

- Adapt files to national requirements and/or prepare local registration files for new products
- Submit files to national Authorities and monitor their progress, act as contact person with the local MoH
- Respond to questions and deficiency notices in cooperation with the Global Regulatory Lead (GRL)
- Maintain licenses current by submitting renewals at appropriate time
- Update files for changes (variations) in cooperation with the GRL
- Perform the in-country tasks related to mutual recognition, decentralized and centralized procedures
- Ensure regular update of the list of drug licensing status and renewals in the appropriate regulatory database
- Supervise the obtaining of MOH-approvals to perform clinical studies for medicinal products and medical devices in the respective country
- Communicate promptly national requirements to the appropriate persons and inform them about upcoming changes

**Your Profile**:

- Bachelor's degree in: Pharma, Chemistry, Biology, Natural Science, Medicine or similar degree in scientific fields
- Minimum 3 years’ experience in CQA/RA in the Pharma/MedTech sector
- Ability of understanding country specific regulations and general quality and regulatory requirements
- Ability to liaise with different functions involved (e.g. W&D, TS, PV) andwith multicultural teams
- Fluency in German and English (spoken and written)
- Good interpersonal and communication skills
- People/Project management skills
- Self-motivation and commitments
- Computer skills (Word, Excel, Power Point, Outlook, corporate software)

**Have we sparked your interest?**

IND-DACH

**Reasonable Accommodations**

**Recruitment Fraud Notice**

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

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