Regulatory Affairs Specialist; Labeling

Req Number: NOVRJP00009200

Req Title: Regulatory Affairs Specialist; Labeling

Client: A major pharma company

Work Address: 100 College Road West, 08540, Princeton, NJ

Duration: 12 Months

Hours per Week: 40.0

Position Summary:

Regulatory Affairs Labeling Associate Level- III is needed to support the Client’ business to prepare, review and compile high quality regulatory labeling deliverables based on Reference Listed Drug labeling, FDA Guidance, regulation and Sandoz internal policies and procedures. Some common labeling deliverables are, Structure Product Labeling (SPL), side-by-side with annotation, document with track changes and any other required documents per process.

Duties:

Independently prepare all essential labeling components, including but not limited to physician insert, patient insert, carton/ carton label, vial label, printed foils for submission.

Maintain all assigned Client approved, pending, and non-marketed products for life cycle management; this includes timely document creation, submission, drug listing, implementation, and archiving all labeling.

Create labeling for new projects, new ANDA and as marketed products based on Reference Listed Drug labeling by including FDA requirements, Client requirements, current regulations, competitor labels, and site-specific requirements.

Supporting and prioritizing launch labeling components readiness for a successful launch.

Support labeling review process with a Quality Assurance and data integrity mindset. Apply team concept to get things done and work collaboratively with everyone.

Applying strategic thinking, pharmaceutical educational knowledge, and regulatory intelligence for complex labeling creation, development, maintenance, and responding FDA deficiencies/queries.

Creating and Maintaining SPLs for products in alignment with changing technical requirements.

Providing recommendation and input for the work process which can help to improve the efficiency and clarification.

Self-Identifying and initiating labeling changes for USP updates, RLD updates, updates per new regulatory requirements, and consistency of all labeling.

Utilizing technical skills for learning new features/applications of software which can support to improve the efficiency and complexity.

Some key traits, should have Generic labeling experience, effective communicator and can work independently and collaboratively with everyone.

Key Performance Indicators:

Supports product submission process through the accurate and timely completion of labeling assignments

Follows all procedures and proactively maintains labeling tracking information

Effectively prioritizes competing tasks in a fast-paced and dynamic environment.

Supports process for labeling creation and update

Performs duties with the highest ethical standards, delivering only high-quality, compliant submission deliverables for FDA

Demonstrate cordial and respect towards all members.

Communicate effectively and transparently with all members.

Qualifications:

Education: Bachelor's or Associate’s degree in a scientific discipline or English.

Experience:

Bachelor’s degree plus a minimum of 6 years in the pharmaceutical industry with 5 of those years in regulatory affairs labeling.

Associate’s degree plus a minimum of 7 years pharmaceutical industry experience, with at least 5 years in regulatory affairs labeling.