Job Title: REGULATORY AFFAIRS MANAGER
Location: Siena - Italy
Department: Clinical
REGULATORY AFFAIRS MANAGER
Philogen would like to hire a Regulatory Affairs Manager who will report to the Management and will provide support in formulating and implementing regulatory...
...role is critical to support senior management as well as Gov Affairs and Global functions by providing expert BD support and leadership... ...Affairs, Medical Governance, Communications, Safety, Quality, Regulatory, Supply, Global Patents, Legal) to support the goals of the...
GlaxoSmithKline
Siena (SI)
5 giorni fa
...~Review all the clinical data listings and tables
~Ensure data management in accordance with applicable standards (e.g. CDISC), regulatory guidelines and company SOPs
~Participate in study team meetings
~Support the Pharmacovigilance department in SAEs reconciliation...
...investigations in a timely manner as well as maintaining an updated knowledge base in the technical, operations, company policy and regulatory fields.
~Management of site products stability studies.
~Facilitating continuous improvement in QC day to day operations and...
...similar.
Extensive hands-on experience in method development within the pharmaceutical industry and a solid understanding of regulatory and GMP requirements.
Preferred Qualifications:
Ph.D. in Analytical Chemistry, Biology, Biochemistry, Pharmaceutical Sciences...
...and TMF audits and checks throughout the lifecycle of a trial/program to ensure compliance with internal procedures, as well as regulatory guidelines.
~Report significant clinical quality deficiencies and/or risks to upper management and actively participate in solving...
...throughout the entire project implementation process
Providing technical guidance for industrial automation, IT architectures, and regulatory compliance in the development, design, and commissioning of automation/software for equipment and systems in collaboration with...
Massimi Sistemi S.r.l.
Siena (SI)
4 giorni fa