||Florham Park, NJ / remote
||Sr. Mgr / Assoc Director
The Regulatory Affairs Labeling Specialist is responsible for creating, updating, and maintaining labeling records throughout a product lifecycle. They will ensure that products meet regulatory labeling requirements for US, EU, Japan, and other countries as required.
The labeling specialist may also be tasked with regulatory review and approval of advertising and promotional material.
Major Responsibilities and Duties
- The primary responsibilities of a Labeling Specialist will be to create product labels and maintain databases of labels, ingredients, and formulas. This will require the associate to research and write proposed labeling, and find agreement with cross functional teams. The associate will interact with regulatory affairs teammates and also cross-functionally with clinical, medical, legal, safety, commercial, quality, and supply chain associates.
- The associate should be knowledgeable of current FDA and EMA labeling regulations, and other global product labeling regulations (PMDA experience not required, but preferred).
- Maintain awareness of US and Global regulatory environment and access impact of changes on product labeling activities. Will be responsible for sharing important changes with the project teams as needed.
- Responsible for continuous quality and compliance throughout the product lifecycle.
- The Labeling Specialist will lead the labeling working teams, and will be heavily involved in health authority labeling negotiations, under the direction and leadership of the Regulatory Strategy lead.
- All procedures and policies regarding this position will require the labeling expert to write or provide input into Standard Operating Procedures (or similar).
- Secondary responsibilities for this position may include advertising and promotional material review on behalf the Regulatory function. This will include submission of the materials to health authorities as required. The company is willing to train the Labeling expert for these responsibilities.
Qualifications and Education Requirements
- Bachelor Degree and at least three years of experience in regulatory labeling, including US and EU labeling experience. Japan experience a plus
- Excellent written and verbal communication skills and interpersonal skills.
- Strong attention to detail and efficiency in proofreading, data entry, and database management is essential.
- Adherence to good practices (GXP), quality, and safety practices
- Experience with regulatory review of advertising and promotional material a plus. The right candidate will be willing to be trained in this aspect