Regulatory Operations Manager

Senior Regulatory Operations Manager (w/m/d)

München, Germany

Acino AG, based in Munich, is part of the Acino Group, a Swiss pharmaceutical company and a leader in advanced drug delivery technologies with its headquarters in Zurich.

Acino out-licenses its own products and manufactures third party products mainly for the European market. In its commercial operations, Acino has a clear focus on selected emerging markets in the Middle East, Africa, the CIS Region, and Latin America. We operate in some of the most dynamic countries of the world. We value courage, commitment, trust, and empathy and provide an environment that supports initiative and effort. We are proud to be action-oriented and open-minded, with a strong focus on quality and product availability, even in remote and hard to reach areas of the world.

We are constantly expanding our market position with a future-oriented international business strategy. Therefore, we are looking for a dedicated and motivated person to strengthen our team in Munich, Germany.

Senior Regulatory Operations Manager (w/m/d)

Major Accountabilities:

• 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.

Your Profile:

• 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 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)

This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If you are interested in this role we are looking forward to hearing from you.

Please apply via our HR system here.

Note that only direct applications via our HR system (follow the link above) will be considered.

Further Information

Our team will be happy to answer any questions you may have about the position or about Acino. You can contact us at: personal.hr@acino.swiss

Only direct applications will be considered.