The Regulatory Affairs Associate II -Cardiovascular will be responsible for providing submission support on at least one development or commercial stage product under the management of the Senior Manager in the Cardiovascular (CV) Regulatory Affairs group.
1. supporting preparation of submissions with the primary company contact with the US FDA for assigned cardiovascular/metabolic products, including Ranexa (ranolazine)
2. support for updates to IND/NDA information in accordance with requirements, including submission of IND amendments and teams working to prepare submissions
3. representing the Regulatory Affairs function as a submission team or study team representative for assigned cardiovascular development projects
4. supporting departmental management in the implementation of systems and processes for Regulatory Affairs
5. developing and maintaining current knowledge of regulatory requirements applicable to assigned projects
The qualified candidate will work with teams to develop and support submission of IND amendments, annual reports, original INDs or NDAs for assigned projects. This person will be responsible for preparation and submission of routine clinical documentation to FDA and contributes to the regulatory review of clinical protocols for assigned projects.
Essential Duties and Job Functions:
Responsible for preparing regulatory submissions which require interactions with departments outside of Regulatory Affairs for investigational and commercial products in line with ICH requirements, regional requirements and scientific and company policies and procedures. Responsible for submissions which may include safety reports, amendments, or supplements to US NDA. Responsible for ensuring product packaging and associated information is updated and maintained in accordance with the product license for assigned products and territories. Participate in group meetings and present project status updates and strategic approaches to moderately complex programs/projects. May initiate or contribute to local process improvements, which have a significant impact on the working of the Regulatory Affairs function or other departments. Excellent organization skills and ability to work on a number of projects with tight timelines is required. Excellent verbal and written communication skills and interpersonal skills are required. General understanding of regulatory requirements, including ICH requirements and regional requirements for assigned territories is required. Work is performed under minimal supervision of a Regulatory Affairs professional.
Knowledge, Experience and Skills:
Minimum of 5 years of experience in Regulatory Affairs and a BS degree in relevant discipline are required; an advanced degree in a scientific field and 1-4 years of direct experience may be acceptable. Bachelors Minimum Requirement / Advanced Degree Preferred.
Regulatory Affairs experience working on development programs is highly desirable. Familiarity with regulatory requirements and ability to rapidly establish therapeutic area working knowledge are necessary. Good verbal and written communication skills and interpersonal skills to facilitate working with a cross-functional team, and excellent attention to detail are required.
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