Pierre Fabre USA Hiring For Regulatory Affairs Specialist at Parsippany, NJ, United States , United States Full Time

Job Description

Within the Quality, Regulatory, Vigilance and Medical Information department, the Regulatory Affairs Specialist is responsible for the local regulatory compliance of all cosmetic, OTC and drug products of Pierre Fabre USA with the FDA, the FTC and all other relevant American jurisdictions. As such, the Regulatory Affairs Specialist will be in charge of regulatory files submission, labeling and promotional material reviews, as well as importer and state license renewal and maintenance.
Essential Functions:

• Coordinate with corporate teams and local Medical Affairs team the preparation of regulatory files for submission to the FDA.
• Ensure product changes are included in the regulatory files and submitted as appropriate.
• Participate in multidisciplinary meetings focusing on regulatory aspects of marketed products and new product development.

• Support expansion plan by preparing scientific and technical documentation on products as necessary.
• Ensure drug, cosmetic and OTC products meet regulatory compliance.
• Review and approve labeling and promotional material including packaging, sell sheets, websites and social media posting to ensure they are truthful, fair balanced, and not misleading or deceptive.
• Ensures maintenance of state licenses, marketing authorizations/notifications (e.g. renewals, variations, payment of fees as relevant).
• Identify the need to escalate possible recall or market withdrawal situations to the executive management.
• Act as a liaison for regulatory inquiries (from FDA, vendors marketing,) regarding cosmetics, OTC, and pharmaceutical drugs.
• Maintain the tracking tools related to their activities
• Participate to on-site FDA GMP inspections and other audits, implement appropriate corrective actions.
• Collaborate with the team on customer complaint logging, investigating and reporting.
• Collaborate with the team on adverse reaction notification logging, documenting and reporting.
• Act as the backup for cosmetic, OTC and medical inquiries.
• Attends corporate meetings relevant to his/her activities as needed.
• Ensures the compliance of their activities with corporate requirements, and actively works at improving internal processes.
• Collaborate as needed with the QRVI team on diverse projects.
• Must be available to work on site two days per week or for any emergency.
• Other duties as required by business needs.

Qualification:

• BS degree or related background experience
• 3-5 years of regulatory experience in a similar industry
• Quality, vigilance and/or medical information experience is an asset
• FDA expertise/experience required

Technical knowledge:

• Solid knowledge of MS Office software (Word, Excel, PowerPoint, Outlook)
• Previous experience with quality documentation or safety databases

Behavioral Skills:

• Detail-oriented, strong work ethics, autonomous
• Solid organizational, problem solving and analytical skills
• Demonstrated strong communication skills, both verbal and written
• Ability to juggle multiple priorities
• Ability to work in fast-paced, changing environment
• Agile, flexible, team player, and willingness to learn
• Strong work ethic

Work Environment / physical demands / position type and expected hours of work

• This job operates in a clerical, office setting. This role routinely uses standard office equipment.
• The normal working hours of the office are from 8:30 a.m. – 5:00 p.m. Monday through Friday.
• We are currently operating with a hybrid work from home schedule.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

True to My Nature
https://www.pierre-fabre.com/en-us
Pierre Fabre is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.