Director Regulatory Affairs, CMC.lmm

Director, Regulatory Affairs -Near Piscataway, NJ
(Title may vary with experience)

The Director, Regulatory Affairs will be responsible for the creation and update of regulatory submissions in accordance with templates and defined electronic submission standards (i.e. hyperlinks, bookmarks, publishing). The Director will report directly to the President and CEO and shall be located at the Company's New Jersey headquarters. Key responsibilities shall include:

Manage the regulatory function and processes of theCompany for the preparation, compilation and submission of all ANDAs,amendments, supplements, periodic and annual reports, control documents,etc. to FDA authorities;
Manage quality control over the entire submissionlifecycle, including all component tracking, workflow execution and issueresolution;
Maintain full awareness of all regulatory activities onassigned projects and ensuring that project deadlines and performancestandards for these projects are established and met;
Oversee timely and comprehensive regulatory docket fordistribution to Senior Management;

Maintain the project planning system for assigned projects/products and identify quality and/or timeliness issues with source documents, as early as possible.
Oversee critical reviews of documentation to assure consistency of regulatory filing and to identify potential gaps for technical liaisons in group and partner companies.
Oversee product publishing, formats eCTD templates, and coordinate electronic submission activities.
Raise major project issues to Senior Management for resolution and agreement.

Work to minimize regulatory issues and helping toprevent unnecessary regulatory delays;
Represent Regulatory Affairs on project teams and serveas team leader for projects;
Interact with FDA and all of the contract via writtenand phone communications;
Directly manage Company regulatory associates anddevelop a fully functional regulatory team;
Liaison with parent company regulatory team and directall regulatory activities in support of the U.S. business units

EXPERIENCE:
v Degree in Science (e.g. Pharmacy, Chemistry, Biology, Biochemistry) or equivalent
v 5+ yr. pharmaceutical industry regulatory affairs experience (generic experience required)
v 5+ yr. knowledge of CMC regulatory and/or CMC documentation preparation experience.
v Strong working knowledge of Microsoft Office and desktop publishing. eCTD submission experience required.
v Good interpersonal, communication and organizational skills