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Sr. Associate of Regulatory Affairs

Company Name:
Scientific Search
position
: Senior Associate, Regulatory Affairs
Position Purpose: The Senior Associate will play a key role in the day-to-day activities of the Regulatory Affairs department. The Senior Associate will work with other Regulatory Affairs department members, or members of other departments within the company (including Marketing, Manufacturing, Legal) to maintain, update, and/or approve various documents, including advertising, sales promotions, technical publications, labels, etc. The Senior Associate will be responsible for handling adverse event reporting. The Senior Associate will assist the Senior Director, Global Regulatory Affairs, and the Associate Director, International Regulatory Affairs, in compiling project data packages.
Reporting Relationships: Position reports to Sr. Director, Global Regulatory Affairs.
Key Responsibilities
o Review all (US and International) advertising and sales promotions, technical publications, market communications, and product specific
public relations
releases.
o Handle completion and submission of all Adverse Event Reports.
o Maintain labeling, MSDS, and contact information for ASPCA Adverse Event Management.
o Work with manufacturing to develop new labeling and to revise existing labeling.
o Assist the sales force and customers with all product related regulatory questions.
o Assist the Senior Director, Global Regulatory Affairs , and the Associate Director, International Regulatory Affairs, in compiling project data packages.
o Review QA/manufacturing Change Controls.
o Manage Regulatory Projects as determined by the Director, Global Regulatory Affairs, and the Associate Director, International Regulatory Affairs.
Accountabilities:
o Work with other departments within the company, including Manufacturing and Quality, and other Regulatory members in a team environment.
o Participate in Regulatory related discussions in regards to marketing materials, product labeling, and product related regulatory questions.
o Assist in planning, organizing, and submitting various Regulatory Affairs data packages.
Key Competencies Required:
Technical:
o
computer
skills are needed, with experience using Microsoft Access, Outlook, Word, Excel and PowerPoint software programs.
Business:
o Knowledge of regulatory requirements for medicated feed additives is preferred.
o Direct experience with various regulatory bodies particularly either CVM-FDA or the FDA (written submissions, direct interactions, etc.) is highly desirable.
o Relevant experience in the regulated pharmaceutical industry is highly desirable.
o Experience with veterinary drugs is desirable.
o Experience participating in project teams is desirable.
Personal:
o The successful candidate must be motivated, creative, have excellent organization and time management skills and possess excellent verbal and written communication skills.
o Ability to multi-task and prioritize multiple projects with minimum guidance.
o Be resourceful, ambitious and be willing to take on new tasks and responsibilities.
o Self-starter.
Education & Experience:
o BS degree in life sciences or related field.
o Minimum 3 - 5 years Regulatory Affairs experience.
o Desirable to have had 3 - 5 years Animal Health industry experience ideally in Regulatory Affairs. Pharmaceutical industry experience also acceptable.

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