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Head of Regulatory Affairs (m/w/d) (DE)
[12904]
Pharma, Regulatory Affairs, Strategy
Positionstitel: Head of Regulatory Affairs (m/w/d) Anstellungsdauer: unbefristet Branche: Pharma Fähigkeiten: 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
- 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
- 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
Marco Bannier