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Manager RA CMC

Boehringer Ingelheim

Rhineland, MO, United States Estimated Salary : $ 61,620 per year Apply Now   
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Job Type: Full Time

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OUR COMPANY

At Boehringer Ingelheim we develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company, we focus on long-term performance. We believe that, if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve; after all, we started with just 28 people. Now, we are powered by 50,000 employees globally who nurture a diverse, collaborative and inclusive culture.

THE POSITION

A lot to do despite Corona! Boehringer Ingelheim is still looking for new colleagues!

Are you looking for a new professional challenge and would like to be involved in the development and approval of new innovative pharmaceutical products in Regulatory Affairs? If so, we offer you the opportunity to use your skills in our global Regulatory Affairs team for animal health.

Tasks & responsibilites

With your expertise in regulations of pharmaceuticals in the EU and in Primary and International Markets you define the regulatory CMC requirements for initiatives and represent the RA CMC function. As RA CMC Product Manager, you are the key point of contact for the internal and external stakeholders regarding any technical and regulatory aspects for assigned products throughout their lifecycle. Additionally you provide technical regulatory support to the Primary Markets as well as to RA colleagues in charge of other regions. As EU Procedure Manager, you are accountable for EU procedures, from the pre-submission activities to the end of the procedure, including the dossier preparation. You work in close cooperation with the European Medicines Agency and local authorities in the context of European procedures.

The Senior Manager role also includes:

The responsibility to define sound regulatory strategies for assigned products and projects. As RA core- or subteam member in projects as well as in programs using your expertise to anticipate changes in pertinent regulations and evaluate the impact on projects and existing products. Working proactively with regulatory authorities to shape pathways for development projects with significant business impact. Representing the company`s interests in trade association, regulatory forum and internal working groups. Requirements Advanced degree in life science (e.g. pharmacist) First industry experience in Regulatory Affairs (preferably CMC) and/or CMC product development Knowledge of the regulatory CMC requirements for pharmaceuticals Expertise of the pharmaceutical product development process and life cycle management Excellent communication and excellent interpersonal skills coupled with analytical and problem solving skills Self-motivated with a high degree of initiative, commitment and persistence Excellent command of English language both written and spoken

For the Senior role in addition you bring:

Several years’ experience in Regulatory Affairs CMC and/or CMC product development with sound knowledge of regulatory CMC requirements for pharmaceuticals Proven exposure working with regulatory agencies and trade associations/working groups Proven competencies in the strategical assessment of new regulations and regulatory trends as well as their impact on the development pipeline and the product portfolio

EFFECTS OF COVID-19

We will continue to hire talented people and we look forward to receiving your applications. As a result of COVID-19, we have introduced alternative working arrangements to ensure that our employees can stay safe and healthy, because the health of our employees is among our top priorities. At all company locations, we work remotely whenever possible. Additionally, we are now hosting virtual video interviews for applicants. During the limited in-person interviews we still have during this time, we pay special attention to distance and the hygiene rules recommended by the Robert Koch Institute. New employees who do not start on site in production or the laboratories are sent the necessary IT equipment, our Welcome Days take place online, and we plan to conduct their onboarding training virtually whenever possible.

WHY BOEHRINGER INGELHEIM?

This is where you can grow, collaborate, innovate and improve lives.

We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices. In addition, learning and development for all employees is key, because your growth is our growth. We also offer a competitive salary, generous amount of vacation time, and numerous benefits towards your wellness & financial health and work-life balance. Plus, an onsite gym (Ingelheim), in-house doctor and best-in-class cafeterias and coffee bars to keep you energized and healthy. To learn more about what benefits could be waiting for you, please visit our Career area.

Want to learn more about us? Visit https://www.boehringer-ingelheim.com/

Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or national origin.

READY TO CONTACT US?

Please contact our Recruiting EMEA Team: Sabine Schätzlein, Tel: +49 (0)6132 77-92199

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