Government Affairs Representative supports the implementation of strategic plans and engagement objectives to develop and maintain productive relations with all levels of government authorities to achieve business goals. Liaises with government entities (federal, state, provincial, or local) that regulate or influence business activities. Being a Government Affairs Representative collaborates with industry groups and organizations with complementary objectives to achieve objectives. Monitors and analyses proposed legislation, emerging issues, and trends and prepare reports and informational documents to inform and support business leaders. Additionally, Government Affairs Representative requires a bachelor's degree in public policy, public administration, business or equivalent. Typically reports to a manager. The Government Affairs Representative work is generally independent and collaborative in nature. Contributes to moderately complex aspects of a project. To be a Government Affairs Representative typically requires 4 -7 years of related experience. (Copyright 2024 Salary.com)
SUMMARY OF POSITION
Independently authors, compiles, reviews, schedules, and submits high-quality regulatory submissions in adherence with technical document standards that are fully compliant with FDA and ICH requirements within company timelines. Plans, coordinates and writes, clear, concise and accurate, responses to inquiries from FDA resulting from their review of the submissions. Submissions will include: ANDAs, Amendments, Supplements, Annual Reports, and 505(b)(2) files. Translates and communicates regulatory requirements and strategies, as they affect regulatory submissions, to more junior regulatory team members and to internal and external functional business units. Works on more complex projects and helps to solve problems where analysis of the situation or data requires evaluation and sound-interpretation of regulatory requirements and/or guidelines. Serves as a backup for the publisher and system administrator for Alvogen’s US Regulatory electronic document management system.
ORGANIZATION STRUCTURE
The Senior Associate, Regulatory Operations/CMC reports into the Manager/ Director, Regulatory Affairs and is based in Morristown, New Jersey.
RESPONSIBILITIES
Primary responsibilities of this role include the following:
QUALIFICATIONS
Job-Specific Competencies/Skills:
“We are an EEO Employer, including disabilities & vets."
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