Excelya

Medical writer

• Preparation of PMCF, CER, CEP, PMS.
• Review of relevant documents.
• Consultation and gap analysis on transition from MDD to MDR.
• Responses to queries from regulatory authorities.
• Perform literature search.
• Appraise literature search data.
• Ability to interpret, evaluate, and translate medical research findings.

Senior Medical Writer, Medical Devices

Compliance

• Oversee the regulatory strategies essential for exporting cosmetics to various international markets.
• Act as the main regulatory contact for regions and partners throughout product lifecycle.
• Collaborate cross‑functionally to ensure compliant and timely submissions.
• Manage project timelines, organize export review meetings, and oversee registration tracking.
• Conduct regulatory risk assessments and propose mitigation plans.
• Monitor international regulatory developments impacting product registration and commercialization.
• Support business teams with pragmatic and compliant regulatory solutions.
• Track and monitor regulatory KPIs related to export activities.

Regulatory Affairs Export Manager – Cosmetics

Clinical Research

• Support clinical trial activities from study start-up to close-out, ensuring adherence to standards.
• Contribute to the preparation and review of trial protocols and amendments.
• Perform medical review of clinical data, including patient profiles and adverse event narratives.
• Collaborate with pharmacovigilance, clinical operations, and biostatistics teams for data review.
• Assist in medical writing and review of study-related documents.
• Ensure proper documentation and filing of study-related materials.
• Support preparation for audits, inspections, and regulatory submissions.

Clinical Scientist

Clinical Operations

• Lead country-level planning and execution of clinical trials, including site selection, initiation, monitoring, and close-out, ensuring recruitment and retention targets are met.
• Manage regulatory and ethics submissions, ensuring compliance with ICH-GCP, local regulations, and sponsor requirements, and tracking approvals and amendments.
• Oversee sites, CRAs, and local vendors, resolving operational issues and escalating risks when necessary.
• Control country budgets and resources, support contract negotiations, and ensure financial accuracy and timely invoicing.
• Ensure quality and audit readiness through regular checks, supporting inspections, and implementing CAPAs.
• Act as the main local contact for global stakeholders, providing progress updates, risk mitigation plans, and maintaining accurate clinical documentation and reporting.

Local Clinical Project Manager

Consultant

• Lead the CMC regulatory strategy for all post‑approval lifecycle activities of assigned small‑molecule assets, providing proactive and timely regulatory guidance to technical teams.
• Manage and deliver all regulatory aspects related to Change Control requests, ensuring compliance with global regulatory requirements.
• Drive and coordinate project management activities supporting CMC post‑approval work, ensuring deliverables are completed on time, within scope, and at the required quality level.
• Liaise with local affiliates to define efficient and compliant regulatory strategies aligned with country‑specific requirements and agreed timelines.
• Represent CMC Regulatory in governance meetings and cross‑functional project forums.
• Write, review, compile, and submit CMC regulatory documentation in support of global post‑approval submissions, in accordance with regional requirements.
• Perform gap analyses and risk assessments to support regulatory strategy and readiness for submissions.
• Identify critical path activities, interdependencies, and rate‑limiting factors across technical and regulatory deliverables.
• Provide clear and regular status updates to internal and external stakeholders.
• Ensure effective document lifecycle management through the appropriate document management systems.

Senior CMC Reg Consultant, Small Molecules Lifecycle

• - Ensure that all information and publicity materials related to medicinal products or healthcare products comply with applicable regulatory requirements
• - Review and approve communication materials intended for healthcare professionals or the general public (e.g. brochures, digital content, training materials, press releases)
• - Verify the scientific accuracy, consistency, and balance of product-related information
• - Ensure communications are aligned with approved indications and regulatory approvals
• - Act as a key contact between Regulatory Affairs, Medical, Marketing, and external partners
• - Contribute to risk prevention by avoiding misleading, promotional, or non-compliant communications
• - Monitor regulatory changes impacting information and publicity requirements

Senior Medical Writer, Medical Devices

Regulatory Affairs Export Manager – Cosmetics

Clinical Scientist

Local Clinical Project Manager

Senior CMC Reg Consultant, Small Molecules Lifecycle

Regulatory Consultant, Information & Publicity