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:

• Review and approval of documents, reviewing investigations and providing inputs based on scientific understanding and compliance acumen, in the Electronic Platform(E.g COMET

• Investigating Non-Conformances/OOS/OOE/OOT.

• Writing Scientific and Compliant Investigations.

• Prepare Weekly Quality Dashboards/Quality Improvement plans(Statistics/Graphs/PPTs).Execution of Q&C Dashboard

• Support Audits/Internal Check Round

• Co-ordinate /Facilitate Training process through Summit Platform

• Implement, maintain and support Daily activity of Laboratory Processes (e.g Training Management, Reference Standard Management etc.)

• Perform Gap assessment of SOP /Preparation/Revision of SOPs in Electronic Platform( TruVAult)

• Scope may evolve based on QA/business needs

• Identify potential issues, perform trouble shooting, resolve conflicts and provide solutions as applicable.

• The contractor will work from the client premises: Mumbai, Maharashtra, India

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, negotiating 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

Experience (Minimum Required):

• At least 5+ year experience in project management and people management is desirable

• Industry experience of which 10-13 years is relevant to Regulatory Affairs/Quality Assurance or other relevant department / Analytical science / Packaging, polymer and/or printing stream / Page 2 of 3 Formulation science / material management and overall drug development and manufacturing process

• Ability to interact and influence with line and middle management, staff and external contacts on a functional and tactical level

• Experience in coaching project team members to strengthen their abilities and skill sets

• Strong attention to deadlines and budgetary guidelines

• Be able to anticipate/identify problems and takes appropriate action to correct.

• Capabilities to face internal and external Audit situation.

• Knowledge of ICH guidelines

• GMP experience

• Excellent skills in computer applications including Word, Excel

• Quality mindset

• Proactive and take initiative

• Open for change and improvement

• Ability to meet deadlines

• Detail-oriented with commitment to high level of data integrity and accuracy

• Able to work independently

• Good team player, excellent verbal and written communication skills with leadership qulaities

• Accuracy and commitment to timeframes

• Able and willing to work in a global environment

• Able to communicate effectively

Preferred Qualifications Include:

• Bachelor’s in Pharmacy or related science degree (or equivalent); or advanced degree (e.g., PhD or Masters) preferred with at least 10-13 years of experience in Regulatory Affairs/Quality Assurance or other relevant department. “Fortrea may consider relevant and equivalent experience in lieu of educational requirements.” OR

• Bachelor’s degree from Engineering /B.Tech /Packaging /Polymer /Printing stream or Packaging Postgraduate/Diploma/Certification in Packaging with at least 10-13 years of experience in Packaging field will be preferred. “Fortrea may consider relevant and equivalent experience in lieu of educational requirements.”

• Knowledge of data management system, pharmaceutical product life cycle and Management Information System (MIS) will be preferred • Minimum 5+ year experience in project management and people management is desirable

• Diploma or certification in Regulatory Affairs will be preferred

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.