Job description:
Clinical Project Manager
1. Proactively manages clinical trials from start-up to closure with a focus on trial timelines, quality, budget, and vendor oversight.
2. Leads selection of CRO and vendors including identification of potential vendors, RFP process, qualification of vendors where required and contract negotiation.
3. Supports preparation of regulatory dossier by providing documents and required information
4. Leads the study start-up process, including, but not limited to, preparation of the trial kick-off meeting, study documents, plans and manuals, set-up of the trial master file (TMF), and site feasibility process (where applicable).
5. Collaborates with the Clinical Trial Supply Management function to ensure an effective procurement and supply strategy for study medication, with no stockouts during trial and low overage at study end.
6. Oversees CRO and vendors during the trial to ensure compliance with project requirements, internal processes, timelines, budget, ICH GCP, and local and international laws.
7. Monitors the quality of vendor deliverables, addresses quality issues with the appropriate team members and identifies opportunities to improve training, execution and quality control.
8. Oversees monitoring of clinical trials, ensuring high-quality trial execution at sites, identification of deviations and implementation of mitigation strategies as required.
9. Ensures study is at all times inspection ready.
10. Provides efficient updates on trial progress to Head of Clinical Operations and Senior Management.
11. Ensures trials are registered in trial registries (as applicable) and accuracy of trial information and that updates and final reporting are submitted on time.
12. Ensures timely shipment and tracking of lab samples to ensure no loss of samples due to lack of operational oversight and availability for timely analysis for study reporting.
13. Ensures risk management plans and contingency plans are available for assigned trials and escalates key study risks to the attention of the Head of Clinical Operations/Senior Management. 14. Reviews and approves vendor invoices in collaboration with the Development Finance Specialist/Finance department personnel to ensure vendor payments occur in a timely manner
15. Supports vendor and site audits, follows up on audit findings to ensure appropriate responses and CAPAs implemented by vendors and sites.
16. Ensures all project-level study documentation is filed in the TMF in accordance with applicable SOPs, guidance documents and regulatory requirements and provides oversight to the CRO team regarding TMF filing, maintenance and archival procedures.
17. Supports preparation of responses to queries from Regulatory, Marketing or any other molecule related queries.
18. Ensures at study end that eTMF is completed and archived, budget reconciled, lab samples and IMP samples retained or discarded as per internal decisions.
19. Supports SOP development and review, participates in internal process improvement activities and other activities as needed.
Read LessKey Responsibilities:
1. Regulatory Strategy & Planning
• Develop and implement regional regulatory strategies for biosimilar product registrations in the Middle East, North Africa, CIS, and Non-EEA countries.
• Ensure alignment with global regulatory strategy and business priorities.
• Conduct regulatory risk assessment and provide mitigation strategies during planning and execution.
2. Dossier Preparation & Submission
• Oversee the preparation, review, and submission of high-quality dossiers (CTD/eCTD format) for new marketing authorizations, renewals, and variations.
• Coordinate with CMC, non-clinical, clinical, and labeling teams to gather required documentation. • Ensure submission timelines are met as per business needs and agency expectations.
3. Agency Engagement & Partner Coordination
• Act as the primary point of contact for Health Authorities in these regions.
• Lead technical and administrative discussions with regulatory agencies to facilitate approvals.
• Collaborate with regional distributors/partners for local submissions and regulatory intelligence. 4. Lifecycle Management
• Manage post-approval changes (variations), renewals, labelling updates, and compliance reporting.
• Ensure timely implementation of changes across the region.
• Maintain up-to-date regulatory documentation and databases.
5. Compliance & Intelligence
• Monitor and interpret regional regulatory guidelines, regulations, and policies relevant to biosimilars.
• Provide periodic update on impact and compliance to regulatory head.
• Support regulatory inspections as needed. 6. Cross-functional Collaboration • Work with QA, QC, SCM, PM, Clinical, Commercial, and BD teams to align regulatory priorities. • Support business development activities, due diligence, and partnership evaluations for the region.
Qualifications & Experience:
• Bachelor's or Master's degree in Pharmacy, Life Sciences, or related field; Regulatory certification is a plus.
• 12-15 years of experience in regulatory affairs in the pharmaceutical/biotech industry, at least 5 years' experience in biosimilars is preferred.
• Strong understanding of regulatory pathways for biosimilars (clinical and analytical similarity requirements) and ICH guidelines.
• Experience with regulatory submissions in MENA and CIS countries is mandatory.
• Familiarity with SFDA, EMA reliance procedures, and dossier localization requirements.
Required Skills & Competencies:
• Strong project management and organizational skills.
• Excellent written and verbal communication skills.
• Strategic thinking with attention to detail. • Proactive, collaborative, and culturally aware.
• Ability to manage multiple priorities in a fast-paced environment
Read LessRole - COE Capability Lead
Designation - Associate/Senior Director
No. of Positions - 1
POSITION SUMMARY
The SCM COE Capability Lead is a strategic leader responsible for elevating supply chain performance through advanced analytics, process governance, and planning excellence. This role drives visibility, maturity, and execution of core planning processes by leveraging data science, planning systems, and stakeholder collaboration to deliver measurable business impact. The role also plays a critical part in enabling people, transforming work, providing governance and expertise, and driving innovation across the supply chain.
OVERALL JOB RESPONSIBILITIES
A significant portion of this role is project-based, meaning the SCM COE Capability Lead will not only manage ongoing responsibilities but also lead and deliver high-impact, cross-functional projects. These projects may vary in scope-from digital transformation and analytics initiatives to process redesign and capability building-and will require agility, strategic thinking, and strong stakeholder engagement.
Key Responsibilities:
1. Analytics & Planning Excellence
Deploy advanced analytics to improve forecast accuracy, inventory health, and service levelsTranslate complex data into actionable insights using Power BI and planning systems (SAP IBP, ECC, others)Drive data science initiatives to support SCM-wide optimization2. Process Governance & Maturity
Lead process maturity efforts across the SCM functionEnsure execution excellence through KPI frameworks, governance routines, and digital toolsImplement business process management and capability maturity modelling3. Stakeholder Engagement & Change Leadership
Align planning strategies across functions through strong stakeholder engagementLead cross-functional projects and change initiativesFacilitate Communities of Practice (COPs) and promote analytics literacy4. Capability Building & Team Development
Mentor teams in planning, analytics, and process improvementDevelop and execute learning and development strategies for SCM roles5. Innovation & Digital Transformation
Champion innovation and digital transformation initiativesSupport configuration and deployment of digital SCM solutionsScout and engage with technology vendors to enable SCM solutionsExperience: Total 10-14 Years
5-8 years experience in supply chain, with the focus on planning, analytics, systems
Education
Bachelor's or Master's degree in Supply Chain Management, Business Administration, Data Science, Engineering, or a related field - MBA preferred
Knowledge and Skills
Deep understanding of core supply chain planning processes (S&OP/S&OE, demand/supply planning, inventory optimization)Advanced proficiency in data analytics and visualization tools (Power BI, Excel, Python - nice to have)Strong command of planning systems and ERP platforms (SAP IBP, ECC, APO)Knowledge of business process frameworks and capability maturity modellingFamiliarity with agile project management and digital transformation practicesInterest or experience in AI/ML applications in supply chain (e.g., scenario/predictive analytics)Leadership/Managerial Attributes
Strong stakeholder management and change leadership skillsAbility to lead cross-functional teams and drive alignment across functionsSkilled in mentoring and developing talent in planning, analytics, and process improvement Strategic thinking with a focus on measurable business impactEffective communicator and facilitator across global and local teamsAbility to work independently without frequent supervision Read LessJob Summary:
Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products including technical and Regulatory aspects.
Responsible for:
• Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolio
• Coordination of activities and deliverables provided by other cross-functional teams to support the development, approval, and long-term planning of biosimilar products
• Collaboration with partners to develop and execute global regulatory activities
• DMF preparations, review of changes and routine updates to Global Regulatory Agencies
• Dossier preparations of Biosimilar biologics for ICH regions Key Activities: Regulatory Strategy and Execution
• Plan and manage development of high quality regulatory documents, including briefing documents, CTAs, IND / IMPD, MAA / BLA, and responses to questions for products in compliance with approved filing plans, timelines, and regulatory requirements
• Provide regulatory direction on global regulatory requirements to support product development
• Ensure all filings are maintained per regulatory requirements and consistent with biosimilar strategy throughout product development and life cycle
• Support development and execution of clinical/non-clinical strategies
• Provide review, input, and regulatory advice into study concept CMC documents, protocols and reports used to support product development and registration
• Collaborate with partners affiliates as required to ensure effective implementation of approved global regulatory strategies and plans
• With minimal supervision, participate in development of risk management and contingency planning
• Ensure and lead regulatory compliance for biosimilar products
• Participation in regulatory meetings with Health Authorities Regulatory Intelligence:
• Monitor, assess and implement global regulatory requirements, guidelines, and policies relating to biosimilar products
• Review and assess impact of regulatory decisions for competitive products • Generate and communicate biosimilar intelligence Collaboration:
• Partner with regulatory team members to research and communicate relevant regulatory information regarding biosimilar products
• Identify process needs to meet internal challenges
• Escalate regulatory issues, progress, and metrics to the GRA Biosimilars function Knowledge and Skills
• Comprehensive understanding of Regulatory activities
• Regulatory experience with product filings
• Team skills, especially in working with internal and external partners
• Familiarity with project management requirements
• Ability to understand and communicate scientific CMC information
• Anticipate and prevent potential issues
• Ability to communicate regulatory strategies and requirements to ensure expectations are understood DMF preparation and updates Briefing book preparation for scientific advices and related administrative tasks leading to submission
Education
Doctorate degree OR Master's degre
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