ASSOC. REGULATORY AFFAIRS II (Labeling Design)

Regulatory Affairs Associate II (Labeling Graphics Designer) is a position in the Corporate Labeling Group within the Regulatory Affairs department for individuals with significant experience in pre-press graphics design. This position will be responsible for creation and revision of dosage form drug container labels and package inserts.

1. Create and revise artwork for Imaging and Pharmaceutical Divisions dosage form drug container labels (bottles, cartons) package inserts and patient leaflets. This will be accomplished using Macintosh hardware and various software applications (QUARK, InDesign, Adobe Illustrator, Microsoft WORD).
2. Ability to accurately review and proofread draft and final documents created.
3. Obtain and maintain knowledge of labeling regulations and the application of labeling regulations. Expand regulatory background through work on projects, researching available documents and attending relevant training.
4. Begin to anticipate regulatory consequences - develop and maintain knowledge of the labeling history and related manufacturing and printing processes. This will aid in the assessment of (1) the consequences of labeling changes for the product and (2) the interrelationship of regulatory and labeling changes for our products.
5. Function as a member of a regulatory/labeling team developing labeling for new products. Multitasking capability and prioritization of ongoing projects in a dynamic environment is essential.
6. Limited contacts outside of company, typically with contract manufacturers and print vendors.

Requirements
1. Demonstrated proficiency in working with Macintosh hardware and various software applications (QUARK, InDesign, Adobe Illustrator, Adobe Acrobat).
Experience: Successful candidate will have a minimum of 3 years experience in computer graphics, using current, standard hardware and software - QUARK, InDesign, Adobe Illustrator, and Adobe Acrobat.
2. Candidate must be very detailed oriented and be proficient at reviewing, proofreading and editing graphics and associated documentation.
3. Must have an excellent working knowledge of Windows based software program Word; knowledge of Excel and Access is a plus.
4 Background in drug manufacturing, marketing, quality assurance sufficient to understand how products are produced, packaged and labeled is a major plus. Understands regulatory application processes and the basis of regulations well enough to quickly learn specific labeling applications. Previous successful FDA submission experience is helpful.
5. Excellent oral and written communication skills. Ability to work well with various departments and people. Capable of making consistent, sound decisions or know when to involve supervisor. Must work well under tight deadlines.
6. Allocates own time efficiently. Handle multiple demands and competing priorities. Willing to take the initiative to learn new tasks/take on more responsibility.