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Regulatory Affairs Associate Jobs in New Jersey

Regulatory Affairs Associate Jobs
By Aditi Consulting At Plainsboro, NJ, United States
Knowledge of FDA and Health Canada eCTD submissions lifecycle management and associated guidance’s/specifications/regulations.
Reports to labeling management in Regulatory Operations and Innovation.
Enters and monitors project and data in Regulatory Label Management systems (LIFT, SPL, ALiCE, novoGlow, etc.).
May be responsible for managing projects, processes, or programs with manager oversight.
Experience and/or Familiarity with Structured Content is preferred
Excellent verbal and written communication and skills.
Associate, Regulatory Jobs
By Revlon At Edison, NJ, United States
Regulatory experience in the cosmetic industry, with a particular focus of EU fragrance allergens is a plus.
IT Skills (Microsoft Office, SAP, etc.)
Analytical skills and understanding technical scientific information
Strong written and oral communication skills are required. Strong interpersonal skills are important for working in fast-paced and matrix driven environment
Gathering, generating, and managing technical fragrance information
Provide Regulatory guidance, and support, including but not limited to:
Regulatory Affairs Associate (Remote)
By Gardner Resources Consulting, LLC At Princeton, NJ, United States
• Experience with submission work in VaultRim
• Experience with RA compliance reports including (NDA, BLA, ODD, DSUR, PBRER annual reports)
Qualified applicants will have the following expertise:
Program Assistant (Regulatory Affairs)
By Rutgers University At New Brunswick, NJ, United States
Equivalent education, experience, and/or training may be substituted for the degree.
Bachelor’s Degree plus one (1) year related experience.
Must be computer literate with proficiency and working knowledge of database and reporting tools such as Microsoft Word, Excel,Access, and PowerPoint.
Demonstrated effective oral and communication skills.
Bachelor’s Degree plus one (1) year related experience in a clinical research regulatory capacity.
Prepares and submits all necessary documents to the Institutional Review Board. Ensures regulatory approvals are obtained.

Are you looking for an exciting opportunity to join a growing Regulatory Affairs team? We are looking for a Regulatory Affairs Associate to join our team and help us ensure compliance with regulatory requirements. You will be responsible for preparing and submitting regulatory documents, monitoring regulatory changes, and providing guidance on regulatory requirements. If you have a passion for regulatory affairs and are looking for a challenging and rewarding role, this could be the perfect job for you!

A Regulatory Affairs Associate is responsible for ensuring that a company’s products comply with all applicable laws and regulations. This includes researching and interpreting regulations, preparing and submitting regulatory documents, and providing regulatory support to other departments.

What is Regulatory Affairs Associate Skills Required?

• Knowledge of applicable laws and regulations
• Excellent research and analytical skills
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team
• Ability to manage multiple projects and prioritize tasks
• Attention to detail
• Proficiency in Microsoft Office

What is Regulatory Affairs Associate Qualifications?

• Bachelor’s degree in a related field such as biology, chemistry, or engineering
• Regulatory Affairs Certification (RAC) is preferred

What is Regulatory Affairs Associate Knowledge?

• Knowledge of FDA regulations and guidelines
• Knowledge of international regulatory requirements
• Knowledge of Good Manufacturing Practices (GMPs)

What is Regulatory Affairs Associate Experience?

• Previous experience in a regulatory affairs role is preferred
• Experience in the pharmaceutical or medical device industry is a plus

What is Regulatory Affairs Associate Responsibilities?

• Research and interpret applicable laws and regulations
• Prepare and submit regulatory documents
• Monitor changes in regulatory requirements
• Provide regulatory support to other departments
• Maintain regulatory records
• Liaise with regulatory agencies
• Ensure