Overview
We are seeking a strategic and experienced Regulatory Affairs professional to lead the development and submission of product registrations and regulatory documentation across the product lifecycle. This role serves as a key liaison with global regulatory agencies, providing expert guidance to cross-functional teams and driving timely approvals for new and existing drugs, biologics, and medical devices. The successful candidate will offer regulatory insights on manufacturing changes, labeling, and compliance, while ensuring alignment with evolving regulations and business objectives.
Responsibilities
* Provides strategic guidance to a team composed of direct reports and vendors, in alignment with regulatory strategies.
* Ensures the selection of qualified talent (team members and vendors) to meet regulatory translation demands.
* Ensures compliance excellence in collaboration with Process, Training and Compliance Team.
* Implements state-of-the-art technologies to accelerate high-quality translations and facilitate submissions as necessary.
* Updates vendors' or service providers' Statements of Work (SoWs) and supervises the team budget as required.
* Has global financial competence over team activities.
* Responsible for the Regulatory Translation Solution group working practices, business guidance, scope-of-services, vendors' guidance, maintenance of terminological termbases, and the provision of relevant trainings to COs regarding Regulatory Translation Solutions group processes as necessary.
* Serves as the Subject Matter Expert (SME) for working practices and/or GOPs involving regulatory translations.
* Maintains clear and regular communication channels with key stakeholders.
* Represents the Regulatory Translation Solutions group in leadership meetings as required.
* Proven leadership skills; member of leadership team, accountable for budget etc.
* Excellent verbal and written communication skills.
* Proven people management skills; preferred include recruiting, retaining and team development.
* Experience in vendor management (customer oriented).
* Forward thinker with the ability to embrace new technologies as necessary.
* Strong compliance mindset.
Qualifications
* Working knowledge of Regulatory Affairs (desirable).
* Commitment to Diversity & Inclusion.
About the Company and Culture
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. We strive to create a collaborative culture that supports growth and impact. This description reflects current expectations and may evolve with business needs.
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