RA-CMC Specialist

hace 4 semanas

Barcelona, España Galderma A tiempo completo

Description

We are looking for an expert in Regulatory Affairs for preparing and updating the CMC (Chemistry, Manufacturing and Control) dossier sections of assigned products (Rx or non-monograph OTC drugs).

This person will contribute to develop RA-CMC strategies for geographical extension and for post-approval CMC activities.

Key Responsibilities

- Contribute to global regulatory CMC strategies.

- Assess regulatory impact of proposed CMC changes and contribute to the CMC regulatory strategies that support change implementation.

- Reviews data provided to support dossier preparation; identify gaps and risks and work with stakeholders to solve them.

- Writes/assembles CMC sections of regulatory submissions

- Develop and maintain project plans and schedules for CMC submissions

- Ensures all CMC dossiers are stored in the company database

- Provide guidance minimally on ICH, FDA and EU CMC guidelines

- Develop and maintain excellent relationships with internal functional groups, contract manufacturing organizations and other relevant partners to ensure alignment of regulatory CMC strategies and successfully accomplish regulatory goals

- Share knowledge and experience with other team members

- Collaborate with service providers contracted to support a project, if appropriate

Skills & Qualifications

- Effective expperience in CMC Regulatory Affairs

- Background in pharmaceutical industry

- Experience with topical and/or systemic drugs (Biologics and/or Small Molecules)

What we offer in return

You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base.

You will receive a competitive compensation package with bonus structure and extended benefit package.

You will be able to work in a hybrid work culture.

You will participate in feedback Loops, during which a personalized career path will be established.

You will be joining a growing company that believes in ownership from day one where everyone is empowered to grow and to take on accountability

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