Teva Pharmaceuticals Senior Director (m/f/d) CMC RA (EU Site RA) in Ulm, Germany
Senior Director (m/f/d) CMC RA (EU Site RA)
Date: Oct 15, 2020
Location: Ulm, DE, 89079
Company: Teva Pharmaceuticals
Who are we?
We want to improve the life of our patients. That is our daily mission. We are proud of our 2,500 employees who provide millions of people with essential medicines every day. And that's not all: we are represented in over 80 countries worldwide, the market leader in generics, the home of Germany's well-known pharmaceutical brand ratiopharm and a leading manufacturer of biopharmaceuticals. In total, we offer a wide range of approximately 700 products. These includes innovative drugs, generics and over-the-counter medicines.
In a nutshell: We are Teva - and we are very proud of it!
If you feel like us and if you are someone who enjoys exploring unknown paths - then we would like to get to know you. Are you also enthusiastic about global markets and technologies? And would you like to develop the future of healthcare at a leading provider of generics and biopharmaceuticals? Fantastic! Then become part of our team!
Curious? Fantastic, then take a look:
A day in Site RA (CMC RA)
Your primary responsibility will be to manage overall 16 Site Regulatory Affairs teams of Teva based in Europe.
You will lead a team of 3 direct reports who are heading the so called SRA Pillars comprising of around 40 employees, based in various European locations (Zagreb, Opava, Debrecen, Athens and Sofia). These teams support Teva’s Third Party Operations (TPO) business as well as other Teva Site RA functions.
In addition you will have a functional responsibility for 13 Site RA Teams located at various Teva manufacturing sites across Europe to ensure that common standards are applied and knowledge is shared across all functions.
In general, the teams are in charge of all Chemical Manufacturing Control (CMC)-related RA aspects after the first product launch. Especially for compiling and keeping up-to-date the related Module 3 documentation for products authorized in EU, International Markets, or US, in line with the legal framework and regulatory requirements.
One of the main tasks is to perform the RA impact evaluation of Change Requests (CR) and advising on the related Module 3 requirements in line with the legislation, as well as on the expected variation classification. You will be in charge of compiling CMC-related variation data packages, and as such work closely with the subject matter experts at the sites. In addition, you will collaborate intensively with Submission RA regarding the related submissions, and also track the status of all required submissions/approvals to support the QA functions and release process at the sites.
Furthermore, Site RA in their role as interface between the Site and Submission RA, will support all regulatory compliance efforts at the sites, and facilitate related process improvements.
In addition, your team supports key projects in Teva Operations (e.g. site transfers, product harmonization, API source changes) by reviewing and providing the Module 3 documents, and participating in the final RA strategy definition. In course of planned new submissions of already existing products, or new clients acquisitions, your team is supporting with GAP analysis of the dossier and adapting the CMC part according to the latest regulatory requirements.
Finally, one of your Pillar teams is responsible for creating and maintaining the Regulatory Compliance Files (RCF) required by some manufacturing sites and TPO.
Within that framework you will have the opportunity to visit the manufacturing sites and to engage with the team as well as the site managers directly. Therefore, the role would require significant traveling within Europe (up to 50 %).
Who are we searching for?
…a strong team player who can work independently with good ability to convince and to manage various stakeholders at different sites
… highly dedicated person with extensive experience in European regulatory affairs and/or CMC background (5-10 years in a managerial position preferred)
… an open-minded candidate with track record as an interface between manufacturing sites, Submission RA and regulatory authorities
… ready to travel up to 40% of the time?
Do you have
… a university degree in the field of pharmacy or natural science
… great communication and presentation skills in English and one additional European language
… international experience and ability to lead intercultural teams in a variety of countries
… strong knowledge of European and international RA regulations
Medical Regulatory Affairs
Vice President Global Quality Services
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Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.
EOE including disability/veteran