Regulatory Affairs CMC Manager, GRAO

Stemline Therapeutics; Sassuolo; Remoto; EUR 55.000 - 80.000; Tempo pieno

Descrizione del lavoro

A leading company in the oncology field is seeking a Regulatory Affairs CMC Specialist / Manager. This role involves significant contributions to regulatory strategies and support for product development, requiring strong skills in regulatory submissions and risk management, preferably with oncology experience. Remote work options are available within Europe, making this a flexible opportunity for qualified candidates.

Competenze

• 3 years of Regulatory Affairs and/or relevant drug/biologic development experience preferred.
• EU regulatory CMC experience desirable.
• Experience in Oncology therapeutic area is highly desirable.

Mansioni

• Planning and preparing regulatory submissions to Regulatory Agencies.
• Track submission timelines and Health Authority Information Requests.
• Collaborate with teams to ensure regulatory CMC strategy is executed.

Conoscenze

Regulatory Affairs

Risk Assessment

Life Cycle Management

Organisational Skills

Formazione

BA / BS / University degree

Descrizione del lavoro

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