Regulatory Operations Expert at Fortrea

Mumbai City, maharashtra, India -

Full Time

Start Date

Immediate

Expiry Date

16 May, 26

Salary

0.0

Posted On

15 Feb, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Project Management, Regulatory Affairs, People Management, cGMP, ICH Guidelines, Quality Assurance, Scientific Investigations, SOP Management, Gap Assessment, Training Management, Data Integrity, Auditing, Conflict Resolution, Negotiating, Influencing, Coaching

Industry

Biotechnology Research

Description

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. Didn’t find what you were looking for? Join our Global Talent Network to stay connected with Fortrea, drive innovation and contribute to our mission of advancing life-saving therapies for patients worldwide. Follow us and stay updated about Fortrea on LinkedIn, Facebook, X, Instagram, YouTube and Glassdoor. At Fortrea, we're all about turning the “impossible” into "I'm possible." Together, we break barriers to deliver exceptional service to our patients, fueled by a shared commitment to teamwork and excellence. Regardless of your role, we're all family, working together to achieve extraordinary results. At Fortrea, your career isn't just a job – it's a journey of making the exceptional possible, every day.

Responsibilities

The role involves managing regulatory operations activities for clients, including the creation, revision, compilation, and approval of regulatory and labeling documents for submissions to global health authorities. Responsibilities also include team management, performance reviews, and resource assignment, while ensuring high-quality, cost-effective service delivery.