(Senior) Manager (m/w/d) Regulatory Affairs CMC
Date: May 12, 2023
Location:
Ulm, Germany, 89079
Company: Teva Pharmaceuticals
Job Id: 48417
Who we are?
Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with.
The opportunity
As a (Senior) Manager (m/f/d) - Global Regulatory Affairs Innovative Medicines CMC you will serve as a RA CMC strategist for biological drug... products and innovative small molecules. The RA CMC strategist is accountable to lead the global regulatory strategy with regard to CMC activities and regulatory activities in pre- and post-approval manufacturing of drug substance (DS) and drug products (DP).
Another important aspect of this role is guiding the subject matter experts (SMEs), Operations and/or QA functions to implement activities that are consistent with these global strategies and/or align with requests and guidance from regulatory agencies.
Furthermore, you will lead and manage other RA CMC colleagues as RA CMC lead for assigned products and oversee the activities within RA CMC being the focal point of contact for other RA and CMC colleagues.
You are responsible for providing the global assessment of regulatory impact for changes related to the site change projects and including the changes into a global roll-out strategy together with supply chain, QA and other functions as needed.
Your experience and qualifications
You are
... highly motivated, committed employee (m/w/d) with collaborative attitude ('team player')
... able to work effectively in a fast-paced environment
... experienced with regulatory documents (files, annual reports, investigations, process changes) and demonstrated ability to work effectively in a variety of IT systems (e.g. EDMS, TrackWise)
... a person (m/w/d) with leadership skills, experience in a matrix organization and culturally diverse working environment
Do you have
... an University Degree in Biology, Biotechnology, Chemistry, Pharmaceutical Science or an equivalent
... a minimum of 5 years professional experience within Regulatory Affairs or Quality Assurance, with a preferential focus on Biologics
... experience with managing teams in a matrix organisation
... experience with general pre- and post-approval requirements with EMA and FDA
... strong understanding of CMC development and DS / DP manufacturing of biologics
... excellent command of English and preferably German (spoken and written)
Enjoy a more rewarding choice
At Teva
... we take care of your health (among other things through a company health management system, a company doctor, physiotherapy, sports activities and a company canteen)
... you have time for your family (through our own company kindergarten and holiday camps for school children, as well as 30 days of vacation)
... you can develop your potential to the fullest (through a comprehensive virtual training program)
... your achievements are valued accordingly (e.g. through recognition and Senior-Leaders-Programs, as well as various company events)
... we think together with you about your future (e.g. through a company pension scheme)
Reports To
Director Global Regulatory CMC
Contact
Orsolya Valkovics, Human Resources
Already Working @TEVA?
If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply:Internal Career Site (https://performancemanager.successfactors.eu/sf/careers/jobsearch?bplte_company=1080030P)
The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
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
Ulm Germany

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