Regulatory Affairs CMC Manager, GRAO

Stemline Therapeutics; Italia; Remoto; EUR 50.000 - 80.000; Tempo pieno

Descrizione del lavoro

A leading company in oncology is seeking a Regulatory Affairs CMC Specialist / Manager based in Europe. This role is essential for the successful development of oncology products, providing regulatory support and oversight. Candidates should have experience in EU regulatory CMC and a background in Life/Health Sciences, with strong organizational skills to drive project timelines in collaboration with global teams.

Competenze

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

Mansioni

• Plan, coordinate, and prepare regulatory submissions for oncology products.
• Support identification and assessment of regulatory risks.
• Track submission timelines and respond to health authority requests.

Conoscenze

Organisational skills

Risk assessment

Communication

Formazione

BA / BS / University degree

Life / Health Sciences preferred

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