Regulatory affairs advisor
Novartis pharma gmbh
- Holzkirchen
stellenbeschreibung
Job Description 8! This is the number of high quality biosimilars for which Sandoz has already received a marketing authorization, and that already provided increased access to life-saving medicines to patients worldwide. Additionally we do have a rich pipeline of further biosimilars under development! For this environment we are recruiting a Regulatory Affairs Advisor (m/f/d) Job purpose:Provide regulatory and strategic leadership to assigned biosimilar/biotech project(s) and prepare, compile and supervise independently and in due time high quality documentation for sophisticated global regulatory submissions in various countries Your responsibilities:
- Lead a Global Regulatory (sub)team, provide strategic input to GPT and GRS / RA team and on key HA documents and represent RA on a Global Program Team (GPT) - Liaison with Regulatory Authorities - Effectively address regulatory issues that may surface during regulatory reviews and prepare and facilitate preparation of responses to Authorities in various countries worldwide - Responsible for development and implementation of the Regulatory Strategy and Risk Documents - Provide regulatory and strategic input on:
- BS or MS with requisite experience and demonstrated capability. Sophisticated degree (MD, PhD, PharmD) preferred. Alternatively several years of regulatory or other meaningful proven experience - At least 5 years of meaningful regulatory and drug/biologic development experience - Good understanding of regulatory requirements for drug development, clinical studies, dossier filings worldwide and critical evaluation of emerging requirements, guidelines for new drugs and product life cycle maintenance - Proven experience in HA negotiations in different regions - Proven project leadership skills and experience in leading in matrix environment paired with proven ability to work in a complex and international setting - Strong interpersonal skills and being a team player - Proficient English required Why consider Sandoz? Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic
And we Never Stop Asking
:how can we continue to pioneer access in an ever-more digital and global world? the answers come when curious, and collaborative people are empowered to ask new questions, make results-oriented decisions and take risks. sandoz, a novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics. join us, and help reimagine access to medicine. sandoz stands up for equal opportunities and for the integration of persons with disabilities. hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability. division sandoz business unit biopharma sz location germany site holzkirchen (near munich) company/legal entity hexal ag functional area research & development job type full time employment type regular shift work no
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