4 months ago
Essential Functions of the job:
- Use knowledge of US, EU and ICH regulatory requirements to plan and manage assigned projects to support corporate goals.
- Assist/lead the preparation and revision of Core Labeling documents (CCDS, CPIL).
- Assist the global labeling governance process, including drafting of SOPs and Work Instructions
- Assist/lead the coordination of the Labeling Committee process, documenting and tracking decisions and actions, and maintaining archives.
- Assist/manage the entire labeling process and management of revisions, including assigning/tracking projects, workflow execution, and issue resolution.
- Assist in the development and maintenance of the end-to-end (E2E) labeling process.
- Build partnerships with key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge and expertise.
- Maintain awareness of global regulatory environment and assess impact of changes on business and product labeling activities. Facilitate policy and development of standard interpretation with internal stakeholders.
- Assist with the development and implementation of regulatory processes.
- Other duties as assigned.
- Understanding of product labeling and regulatory requirements in the pharmaceutical industry and ability to manage global core labeling processes.
- Strong business acumen and ability to make sound decisions that contribute positively to the business.
- Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism.
- Excellent oral and written communication skills are a must, as are superior planning skills.
- The candidate should be detailed-oriented, a self-starter, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced environment.
- Regulatory Affairs Labeling experience is highly desired.
Education Required: Bachelor’s degree (BS/BSc or BA), preferably in a scientific or health-related discipline, with at least 3 years (Manager).