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
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:
- BS, MS or PhD in a scientific field
- 10-15 years of Regulatory Experience
- Global Regulatory Submission Management experience including INDs, NDAs, CTAs
- Familiarity with ICH and Global Health Authority regulation and guidance which governs investigational drug development and marketing applications
- Experience reviewing and writing Standard Operating Procedures
Competencies:
- Able to read, comprehend, write, and speak English fluently
- Collaboration with external vendors and CROs
- Excellent written and verbal communication and interpersonal skills. Able to communicate complex information clearly and succinctly, both in writing and orally
- Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook), SharePoint, Box, Adobe Pro
- Must be highly detail-oriented and have strong organizational and time management skills. Ability to multi-task, manage and prioritize various and differing projects, as well as work effectively toward numerous deadlines
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