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.

Qualifications (Minimum Required)

Bachelor's in pharmacy or related science degree (or equivalent); advanced degree (e.g., PhD or Masters) with experience of 7-9 years. Fortrea may consider relevant and equivalent experience in lieu of educational requirements. OR
Bachelor's degree from Engineering /B.Tech /Packaging /Polymer /Printing stream with at least 79 years of experience in Packaging field or Packaging Postgraduate/Diploma/Certification in Packaging with minimum 7-9 years of experience will be preferred. Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Bachelor or Master degree, scientific oriented (pharmaceutical, chemical or biological sciences) or equivalent by experience with at least 10-15 years experience in pharmaceutical industry preferably in the Quality assurance department
Speaking-English and/or other languages as applicable.

Experience (Minimum Required)

At least 1+ year experience in project management and people management is desirable.
Industry experience of which 7-9 years of experience in the job discipline (e.g. Regulatory Affairs / Quality Assurance / Analytical science / Packaging, polymer and/or printing stream / Formulation science / Material Management and overall Drug Development and Manufacturing Process.
Technical proficiency with Microsoft Office suite of applications/ Document Management and/or publishing tools.
Good understanding of the pharmaceutical product life cycle and regulatory requirements, GxP and ICH-GCP guidelines desirable.
Good organizational and time management ability.
Good analytical capabilities and Customer focus.
Good verbal, written and presentation skills.
Leadership capabilities.
High degree of accuracy with attention to detail.
Ensure client and global regulatory compliance.
Anticipate/identify problems and takes appropriate action to correct.
Capabilities to face internal and external Audit situation.
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 qualities
Accuracy and commitment to timeframes
Able and willing to work in a global environment
Able to communicate effectively
Quality mindset

Preferred Qualifications Include

Bachelor's in pharmacy or related science degree (or equivalent); advanced degree (e.g., PhD or Masters) with experience of 7-9 years. Fortrea may consider relevant and equivalent experience in lieu of educational requirements. OR
Bachelor's degree from Engineering /B.Tech /Packaging /Polymer /Printing stream with at least 79 years of experience in Packaging field or Packaging Postgraduate/Diploma/Certification in Packaging with minimum 7-9 years of experience 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.
Knowledge of data management system and pharmaceutical product life cycle will be preferred.
1+ 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.

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Regulatory Operations Principal Specialist