Senior Regulatory Affairs Director for Global Labelling
1 week ago
Job Summary:
We are seeking a highly experienced Senior Regulatory Affairs Director to lead our global labelling strategy. This is a critical role that requires strong leadership and regulatory expertise to ensure compliance with healthcare industry regulations.
About the Role:
- Lead the development of a comprehensive global labelling strategy, ensuring alignment with regulatory requirements and company goals.
- Directly oversee the maintenance and development of Controlled Correspondence Document Sets (CCDS) and local labelling deliverables for regulatory filings.
- Chair cross-functional committees to manage the decision-making process for labelling updates to established products.
- Design and implement strategies for the creation of a dedicated global labelling function, driving best-in-class processes and metrics.
- Liaise with other Regulatory Affairs functions to ensure timely submission and implementation of labelling updates.
- Provide strategic interpretations of labelling regulations and guidelines in various markets, including the US and EU.
- Ensure compliance and performance of labelling processes in accordance with departmental KPIs.
Requirements:
- Bachelor's Degree in a Scientific or Life Sciences Discipline, preferably with significant experience in Regulatory Affairs Labelling.
- Demonstrated subject matter expertise in labelling and labelling governance, with direct experience in CCDS, Core Product Information, and local labelling.
- Strong leadership skills, with experience leading labelling professionals and a global labelling team.
Key Skills:
- Excellent communication and interpersonal skills, with the ability to influence stakeholders at all levels.
- Ability to clearly explain complex labelling concepts to senior stakeholders and Regulatory Affairs colleagues globally.
- Strategic problem-solving skills, with the ability to drive issues to resolution.
Compensation and Benefits:
The estimated salary for this position is $140,000 - $160,000 per annum, depending on experience. We offer a comprehensive benefits package, including health insurance, retirement plans, and paid time off.
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