Regulatory Operations Expert

Job Overview:

Perform various project management and regulatory affairs activities for Fortrea clients. Manage team including performance reviews, human resource issues, and assist Senior Management in assigning resources to projects as required. Manage, coordinate and oversee the overall Regulatory Operations associated with creation/revision/compilation/approval of specifications, regulatory and labeling documents across the product lifecycle for submission by Fortrea clients to US, EU, Japan, and ROW health authorities within the agreed/stated timelines, as applicable. The post holder is responsible for supporting team members in providing this service to clients either as a support function to the client project groups or as stand-alone business. Provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner.

Summary of Responsibilities:

• The contractor will report into the team lead of the QA Laboratory group of CSQ of the global Product Quality Management (PQM) organization located In Beerse Belgium.
• The contractor will work from the JnJ premises: Mumbai, Maharashtra, India
• The team is responsible for quality oversight and quality assurance support for the JnJ laboratories, and their contract laboratories used by TDS.
• Review and approval of documents such as but not limited to protocols and report for Method qualification, method validation, transfer; methods; investigations.
• Handling of Quality Issues, Corrective/Preventive Actions, and Change Controls related to the SMPD laboratories as well as their contract laboratories
• Works with the supported departments to maintain and continuously improve the quality culture to positively influence Quality KPI.
• Actively participates to meetings with business such as Capa board, Quality improvement program and team e.g. connect meetings

Qualifications (Minimum Required):

• Bachelor or Master degree, scientific oriented (pharmaceutical, chemical or biological sciences) or equivalent by experience
• 3-5 years’ experience in pharmaceutical industry
• Experience and affinity with the laboratory environment (method development method validation, release & stability testing, micro,…), quality assurance, pharmaceutical development, instrument qualification, IT, automation
• ability to work across organizational boundaries, cultures
• influencing, negotiation and partnering in a global environment
• Positively react to changes and show agile behavior
• In-depth knowledge of cGMP and ICH guidelines
• Excellent verbal and written communication skills (English)
• Demonstrates Diversity & Inclusion behavior
• Team player

Physical Demands/Work Environment:

• Physical demands: Available for regional or global travel 5-10% of the time including overnight stays as necessary consistent with project needs and office location.
• Work environment: Office environment or remote.

Learn more about our EEO & Accommodations request here.