Regulatory Affairs CMC Specialist / Manager, GRAO
Remote work / hybrid from within Europe
The Regulatory Affairs (RA) CMC Specialist / Manager is a member of the Global Regulatory Affairs Oncology department. He / she will be a key contributor for the successful development of Stemline / Menarini's portfolio and responsible for assisting with the implementation of the regulatory strategies for the oncology pipeline.
The RA CMC Specialist / Manager will provide regulatory CMC support and oversight for assigned products. In this role, He / She will support the implementation of global regulatory strategies and registration CMC requirements for one or more products / regions.
The assigned programs may have a different level of complexity with more than one indication, formulation, or external business partner.
Responsibilities
* Planning, coordination and preparation of regulatory submissions to the Regulatory Agencies, supporting the Global Regulatory CMC Lead (or delegate) on assigned oncology products.
* Support the identification and assessment of regulatory risks associated with assigned project responsibilities and assist in defining strategies to mitigate risks.
* Track submission timelines.
* Track Health Authority Information Requests and participate in the development and submission of team responses.
* Represent regulatory CMC on project teams for assigned projects.
* Collaborates with Global / Regional and Local (country) counterparts to ensure global / regional regulatory CMC strategy is defined and executed upon for all projects within the area of responsibility.
* Secure alignment between regulatory functions within the Global Regulatory Team (GRT) and the quality functions as well.
* Interacts with teams and key stakeholders in multiple departments at all levels.
* Ability to efficiently interact with a variety of external contacts (including consultants / contractors, corporate partners and regulatory agency personnel).
* Provides the regulatory-CMC assessment of the quality changes during development (e.g. clinical trials) and post-approval phases, worldwide, in collaboration with Regional and Local (country) counterparts where applicable.
* Authors and / or reviews of health authority CMC documents as required, including investigational and marketing applications, responses to Health Authority requests, meeting requests, briefing packages, annual reports, post-approval variations etc, worldwide.
* Manage regulatory CMC data and information within systems.
Qualifications
* BA / BS / University degree required; Life / Health Sciences preferred.
* Preferred 3 years of Regulatory Affairs and / or relevant drug / biologic development experience.
* Experience with life cycle management.
* EU regulatory CMC experience; RoW regulatory CMC experience would be desirable.
* Experience in interpretation of regulations, guidelines and policy statements.
* Experience and knowledge in the preparation of Regulatory submissions and supportive amendments or supplements (CTAs / MAAs).
* Experience in an Oncology therapeutic area is highly desirable.
* Direct experience of interfacing with relevant regulatory authorities is a plus.
* Ability to work both independently with minimal direction and within project teams to attain group goals.
* Strong organisational skills, including the ability to prioritise workload.
J-18808-Ljbffr
J-18808-Ljbffr
Regulatory Manager • Emilia-Romagna, Modena, Italia
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