Senior Regulatory Operations Manager
vor 6 Monaten
Senior Regulatory Operations Manager (w/m/d)
München, Germany
Established in 1836, Acino is a pharmaceutical company headquartered in Zurich, with a clear focus on selected markets in the Middle East, Africa, the CIS Region and Latin America. With over 3,000 people across 90 countries, we deliver quality pharmaceuticals to promote affordable healthcare in these emerging markets and leverage our high-quality pharmaceutical manufacturing capabilities and network to supply leading companies through contract manufacturing and out-licensing.
The Position
The Role
As a Senior Regulatory Operations Manager, you will you will play a pivotal role in ensuring compliance with regulatory standards by maintaining an up-to-date understanding of the regulatory environment and GxP data requirements, while also coordinating data administration, dossier compilation, and user training within our regulatory operations team.
Your Opportunities
Development and maintenance of thorough and up-to-date understanding of the regulatory environment and GxP data requirements. Monitoring of legislation related to CTD, eCTD, xEVMPD, IDMP, eSubmissions, and new trends related to DMS, publishing, and databases. Evaluation of the regulatory environment for an internal advice within the respective area to ensure data and documents compliance. Coordination and Execution of data administration in regulatory databases including data entry within RegOps responsibilities, user requests solving, data quality and integrity controls, RA reporting. Coordination of dossier compilation, electronic publishing into any required format, and technical validation. Coordination and Execution of user training and support, providing the expert information and opinions, creation and update of user guides and training materials. Identification of gaps in RegOps processes and work with line manager to implement necessary new processes (SOPs, WIs) and perform processes revision. Communication with peers and supervisors and alignment on issues and goals. Act as a liaison between Regulatory Affairs and IT, provide support to stakeholders and customers. Provide regulatory input and appropriate follow-up for inspections and audits. Participation in defined tasks of IT projects related to the RA information systems development, implementation, enhancement, and in the process of change control of the respective RA information systems. Participation in defined tasks of computerized systems validation activities and user testing of the respective RA information systems. The employee will perform other tasks under the direction of Head Regulatory Operational Excellence within the agreed type of work.
Who You Are
Master (Bachelor) Degree in Chemistry, Biotechnology or Biomedical sciences (Medicine / Pharmacy / Pharmaceutical Sciences / Science), post-graduate in business or sciences as a plus. Three to five years’ experience in regulatory operations or in data management in GxP environment. Knowledge in regulatory requirements, process, procedures & pathways. Experience in electronic document management systems eDMS and regulatory information management systems RIMS. Experience in working in project teams or leading projects. Good communication skills, both verbal and written, with a passion for accuracy and attention to detail. Good interpersonal skills – ability to effectively interact with a diverse group of people from different functions, of different nationalities and at different levels within the company. Good project management skills. Leads integrated regulatory process and system improvement initiatives that will influence and build new capabilities for greater effectiveness and efficiencies. Willingly accepts challenging assignments and new career opportunities that stretch and build capabilities.
We Are Acino
At Acino, we push the boundaries to deliver high-quality pharmaceutical products that improve patients’ lives. Driven by our collective purpose to provide access to medicines to those in need, our strength lies in our unique expertise and presence in emerging and high-growth markets. We are proud to be challenging the status quo in the pharmaceutical industry, always looking ahead to the future with an open mind.
Join Acino, a dynamic and rapidly growing environment where your contributions can make a real difference.
Acino is an Equal Opportunity Employer.
We offer a very attractive working environment within a highly motivated team with excellent working conditions. You can expect the following benefits:
An international working environment in a constantly growing company A quality and customer-oriented environment A motivated, agile and service-oriented team Interesting and highly diversified tasks that provide a broad basis for your future career in the pharmaceutical industry Attractive salary Flexible working hours (possibility of home office)
How To Apply
Note that only direct applications via our HR system (click on the button below) will be considered.
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