[Hiring] Regulatory Operations Principal Specialist @Fortrea

Role Description

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

• Provide analytical support for developmental projects/comparative dissolution projects received from other client sites.
• Interface with contract laboratories, suppliers, customers, and peers to define and improve project performance and expectations.
• Coordinate with CRO and ensure that projects are completed within timelines.
• Design scientific experiments and actively monitor lab work.
• Recommend expansion or curtailment of investigations based on experimental results or scientific information.
• Prepare test methods, technical documents, protocols, and reports whenever required.
• Ensure proper recording of information and retention of records and raw data.
• Summarize, interpret, review data, and draw conclusions.
• Analyze and interpret dissolution data sets.
• Troubleshoot problems associated with instruments or methods.
• Perform activities following GMP/safety requirements related to assigned activities.
• Participate in process improvement initiatives.
• Work closely with clients to ensure client satisfaction and delivery of services meets or exceeds Service Level Agreements.
• Collaborate with the Quality Assurance department to develop SOPs and training material.
• Assist in training and mentoring of the project team.
• Implement process and productivity improvements to enhance operational efficiency.
• Prepare and participate in audits by clients or regulatory agencies.
• Contribute to solving technical and/or operational problems identified by program/project members.
• Work with company leadership to define project objectives, processes, policies, procedures, and rules.
• Participate in cross-functional meetings as needed.
• Cascade relevant information from internal and external meetings to appropriate colleagues.
• Assist with the generation, review, and implementation of SOPs, Work Instructions, etc.
• Maintain strong analytical scientific and project management skills.
• Possess knowledge of Regulatory Guidelines on dissolution studies (e.g., FDA-SUPAC and ICH).
• Have hands-on experience in various analytical techniques (e.g., HPLC, GC, UPLC, KFT, Particle size measurement) and their troubleshooting.
• Exhibit good communication and presentation skills with experience in a regulated environment.
• Demonstrate decision-making capabilities and good collaborative, planning, and execution skills.

Qualifications

• Bachelor’s in pharmacy or related science degree (or equivalent); advanced degree (e.g., PhD or Masters) with 7-9 years of experience.
• Bachelor’s degree from Engineering/B.Tech/Packaging/Polymer/Printing stream with at least 7-9 years of experience in Packaging field or Packaging Postgraduate/Diploma/Certification in Packaging with minimum 7-9 years of experience preferred.
• Speaking English and/or other languages as applicable.

Requirements

• Multimedia dissolution testing experience.
• Knowledge of Regulatory Guidelines on dissolution studies (e.g., FDA-SUPAC and ICH).
• At least 1+ year experience in project management and people management is desirable.
• Industry experience of 7-9 years in job discipline (e.g., Regulatory Affairs, Quality Assurance, Analytical science, Packaging, polymer and/or printing stream, Formulation science, Material Management, Drug Development, and Manufacturing Process).
• Technical proficiency with Microsoft Office suite and Document Management/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 take appropriate action to correct.
• Capabilities to face internal and external audit situations.
• Good communication and presentation skills.
• Team player with decision-making capabilities.
• Good collaborative skills, planning, and execution.
• Knowledge of in vitro dissolution testing and comparative dissolution testing.
• Interface with contract labs and dissolution investigations.
• Basic knowledge of formulation (oral solid dosage forms).
• Expertise in GC-MS.

Preferred Qualifications Include

• Bachelor’s in pharmacy or related science degree (or equivalent); advanced degree (e.g., PhD or Masters) with 7-9 years of experience.
• Bachelor’s degree from Engineering/B.Tech/Packaging/Polymer/Printing stream with at least 7-9 years of experience in Packaging field or Packaging Postgraduate/Diploma/Certification in Packaging preferred.
• Knowledge of data management systems and pharmaceutical product life cycle preferred.
• 1+ year experience in project management and people management desirable.
• Diploma or certification in Regulatory Affairs preferred.

Physical Demands/Work Environment

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