Lead Regulatory Affairs
Vor 7 Tagen
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For our site in Linz, Austria we are looking for a
**Lead Regulatory Affairs Manager (w/m)**
**Your tasks**:
- Expert and contact person for regulatory issues in the context of the production of active pharmaceutical ingredients (APIs) at the site Linz as well as in the global company network.
- Self dependent regulatory support of products and projects (development and transfer projects) as well as location-relevant regulatory activities (e.g. Site Master File)
- Coordination and preparation, review and ongoing updating of filing dossiers (CMC, CEP, Drug Master File, etc.) for active pharmaceutical ingredients (APIs) in accordance with the respective national and international regulations.
- For own products: Submission of the required documents to the authorities in compliance with the respective requirements and systems (e-submission, etc.)
- Responsible for the system for the electronic archiving of submission documents.
- Support of customers on regulatory topics like coordination of submission strategies, support in the approval process, regulatory evaluation of change control documents, etc. with authorities (FDA, EMA, PMDA,...)
- Enjoy working with people in a dynamic environment.
**Your qualifications**:
- Completed scientific studies or college of higher education (chemistry, pharmacy, etc.)
- Several years of experience in the field of regulatory affairs in pharmaceutical industry, preferably in the API business.
- Experience in handling projects is an advantage.
- Strong process thinking, assertiveness and initiative.
- Good command of English and good knowledge of MS Office.
**We offer**:
- a job with an innovative, forward-looking employer.
- excellent development and career prospects in a globally growing company.
- company pension scheme.
- an exciting corporate culture that stands for integrity, intensity, inclusion and innovation.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or any other legally protected status.
Agency notice
**Our offer**:
The payment is made according to the collective agreement of the chemical industry Ö. The monthly gross salary for this position is at least € 3.389,68. Depending on qualifications and experience, an overpayment is possible.
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