Associate Director/Director, Regulatory Affairs Submissions and Operations
Associate Director/Director, Regulatory Affairs Submissions and Operations
Position Summary:
This role reports to the Senior Director of Global Regulatory Affairs with the primary objective to execute and pull through regulatory strategy and guidance, ensuring a fully compliant and successful outcome for the company and partners. The selected candidate must have a working knowledge of global regulations, submission practices and requirements with proven attentiveness to detail to translate the company regulatory strategy into compliant submissions and best practices.
The role is accountable for three main areas:
1\. Regulatory submission planning, prioritization, execution and successful delivery to health authorities.
2\. Various Operational aspects of regulatory submissions including document management.
3\. Support for Regulatory Strategy including providing input on the regulatory development plan.
The incumbent will work in a close cross-functional partnership with all functions within the company. as well as with Contract Research Organizations, alliance partners and vendors performing work on behalf of the company.
Duties and Responsibilities:
Regulatory Operations
Regulatory Submission Management
Vendor/Partner Management
Other responsibilities
Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and Experience:
Competencies: