Lead Regulatory Affairs
vor 2 Wochen
**Lead Regulatory Affairs (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.
**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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