Senior Associate Regulatory Affairs - Labeling

Meitheal Pharmaceuticals • Chicago, IL

52d • $70,000 - $85,000 • Hybrid

About The Position

The Senior Associate of Regulatory Affairs, Labeling, is responsible for providing effective support to the Labeling function in Regulatory Affairs, in compliance with the FDA regulations, 21 CFR Part 201 and internal labeling policies and/or procedures.

Requirements

• Bachelor's degree in life sciences from a 4-year college or university; over 4 years related experience and/or training; or equivalent combination of education and experience.
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
• Ability to write reports, business correspondence, and procedure manuals.
• Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• The ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Adobe Systems (Pro, Acrobat DC and Illustrator), Microsoft Office, DocuProof, Barcode Studio
• Planning and Organizing
• Teamwork
• Problem Solving
• Quality
• Judgement
• Dependability

Responsibilities

• Performs daily labeling functions in Regulatory Affairs which includes creation of draft labeling, revision of current labels and/or FDA deficiency letters.
• Creation and maintenance of all SPL (Structured Product Labeling) and PLR (Physicians Labeling Rule) files to ensure accurate rendering for all products.
• Makes strategic and critical decisions regarding patents, carve-outs and labeling content.
• Assesses labeling processes and practices for efficiency and continual improvement.
• Format/develop labeling annotations and deficiency responses.
• Meet deadlines and goals in a timely manner.
• Proofreading and annotating label copy to the highest quality standards.
• Ability to document changes and justification by developing and creating change controls.

Benefits

• Hybrid Work Schedule: Enjoy the flexibility to work remotely three days a week.
• Casual Dress Code: Embrace a relaxed and comfortable dress code that allows you to express your personal style.
• Collaborative Culture: Join a team that values open communication, teamwork, and the exchange of ideas.
• Professional Growth: We offer ample opportunities for professional development and career advancement.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Number of Employees: 101-250 employees