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Head of Regulatory Affairs (m/w/d)
Wien |
Permanent
Positionstitel: Head of Regulatory Affairs (m/w/d)
Anstellungsdauer: unbefristet
Branche: PharmaFähigkeiten: Pharma, Regulatory Affairs, Strategy
Idealer Startzeitpunkt: ab sofort
Einsatzort: Wien
Aufgaben:
- Lead the RA department consisting of 3 groups and provide leadership and development to these groups
- Direct, control and implement all regulatory activities worldwide and ensure timely and high-quality submissions
- Define and implement regulatory strategies for the products
- Build the Regulatory structures and organisations globally
- Provide input to the regulatory submission strategy for new clinical development programs for early to late-stage developments
- Provide regular updates on the status of all pending applications and planned submissions
- Establish processes with HQ stakeholders and country organizations to ensure compliant and lean processes for HQ GxP requirements and countries
- Manage interactions and tight cooperation with EMA, FDA and national authorities and handle queries from regulatory agencies
- Monitoring of international regulatory requirements and market-specific registration requirements
- Participate in regulatory review of potential in-licensing opportunities/participation in regulatory due diligence activities
Qualifikationen:
- Scientific background and multiple years of experience in Regulatory Affairs in the pharmaceutical or biotech industry at an international level
- Ability to work in a global environment, individually as well in multi-disciplinary team, and with external partners and regulators
- Industry experience in all aspects of regulatory affairs
- Excellent communication and presentation skills in English (working language)
- Highly developed analytical, problem-solving and consulting skills
- Strong leadership, influencing and negotiation skills
- Flexible team member with positive attitude, energy and ability to prioritize projects
Referenznummer:
Branche:
Beginn des Projekts:
Dauer:
Anstellungsart:
Kontakt
Marco Bannier
12904
Pharma
13.04.2023
n. A.
Permanent
