Regulatory Affairs Associate - Pharmaceuticals
Company: Gables Search Group
Location: Lancaster
Posted on: April 10, 2021
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Job Description:
Summary of the Position: The Regulatory Affairs Supervisor
reports to the Director Regulatory Affairs. The Regulatory Affairs
Supervisor supervises the work of the Jr. Regulatory Affairs
Administrative Assistant and is responsible for the day to day
activities associated with regulatory affairs.Roles and
Responsibilities:* Providing input on policies and objectives
involving matters of federal and state government regulations that
affect Company Products* Assisting with establishing company
positions on applicable federal and state regulations and helping
to communicate agreed upon positions internally and externally*
Working with the Business Unit/Marketing Manager to develop
procedures to ensure regulatory compliance including assisting in
streamlining the routing process for packaging and promotional
items* Interfacing with government regulatory agencies and
officials on behalf of the Company and fostering communication and
relationships with such agencies/officials* Maintaining current
understanding of the regulatory environment for Company products
and communicating any key issues or changes internally* Maintain
current and develop future listing in the Canadian Low Risk
Veterinary Health Products Program* Ensuring timely payment and
filing of registration, license, reports and fees necessary for
Company Products* Assisting in providing regulatory subject matter
expertise and training to the Company* Providing representation to
and participation in industry trade groups as requested* Working
with Production, Quality, Marketing, Legal, New Product Development
and other necessary departments as a representative for regulatory
affairs matters for Company Products* Updating and informing
Director of any issues and progress issues of regulatory projects*
Must be able to effectively communicate with other departments and
function within a team environment* International Regulatory
Activities* Maintains all (electronic/hard) files current and
organized to minimize staff time to identify, locate, and obtain
relevant information in the regulatory document databases*
Processes requests for export certificates with the USDA* Sets-up,
organizes and maintains regulatory and government affairs filing
system and compliance documents* Coordinates and maintains
licenses, registrations, applications, renewals for products with
International regulatory officials* Assists with updating all
applicable department/corporate policies* Performs research by
Internet and/or reviewing files for ingredient acceptance in new
markets* International label guidance and dossier document
development* Updates job knowledge by participating in educational
opportunities* Facilitate translation of International Labels*
Consumer product regulatory review* Perform other assigned duties
as may be required in meeting company objectivesMinimum
Requirements:3 to 5 years regulatory affairs with a veterinary
manufacturer/animal health industry experience. Experience in
feeds, nutritional supplements and a pharmaceutical regulation
required. Must possess strong organizational and leadership skills
with the ability to multitask in a fast-paced environment. Maintain
registrations, renewals, and regulatory compliance with minimal
supervision. Strong written and verbal communication skills
required. Must be computer literate. Prior experience with industry
trade associations (AAFCO, NASC, AFIA, PFI) is a must.Education and
Experience* Bachelor's degree as a minimum* Formal training in
regulatory compliance, AAFCO, NASC* Advance degree such as MBA is a
plus
Keywords: Gables Search Group, Rock Hill , Regulatory Affairs Associate - Pharmaceuticals, Healthcare , Lancaster, South Carolina
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