Senior Specialist - Global CMC Regulatory

Job Description

Management and Planning: Ability to execute assigned tasks independently Adherence to agreed timelines and proactive communication of any potential risk to the same, follow up with cross functional contributors on their deliverables in a proactive and timely manner Strong project management and documentation skills, proactive communication approach Maintain appropriate risk assessment and mitigation in cooperation with line manager /team lead Ability to work within a matrix organisation, build relationships with internal or external stakeholder Provide high quality deliverables as per company standards, right first time Profound knowledge of the companys systems and databases (APT, Trackers, RIMS/Veeva, EDMS) Familiar with the organization and able to identify relevant contributors and stakeholders within the organization as per project Providing Regulatory expertise into the planning and execution of projects and tasks Acts as a role model and helps the more junior staff to improve their business communication skills Encourages team/peers to take an active role in networking activities within own area of specialization/ project environment Focuses on facts and quality of work rather than origin of ideas (does not follow cultural stereotypes) Recognizes other s point of view and makes sure that everyone is listened to and understood Demonstrates high proficiency and delivers high quality influential presentations within the own area of specialization/ project environment Facilitates effective teamwork in own area/project by unearthing and managing conflicts effectively Pursues active networking within and often beyond disciplines/ areas, projects Reaches out to international colleagues and plays an active role in the international expert community Systems and Applications: Upon completion of a dedicated training, user can perform routine/ standard activities within the RA systems with no supervision required The output of the user will usually undergo standard QC/spot check procedure Regulatory Expertise: Solid experience in Regulatory Affairs regulatory dossiers and regulatory procedures on a global scale, including submission/registrations types and related requirements Understanding of Regulatory Agencies structure, processes and key personal as applicable In Ability to review and interpret country specific and international regulatory guidelines, policies and regulations to generate submission ready deliverables as per request Pharma business acumen: Have a good understanding on how business operates and makes smart decisions trying to see the big picture without losing view of the details Ability to develop and prepare successful regulatory CMC strategies and CMC dossiers Practical experience in one of the following areas for synthetic molecules and/or biotech molecules: manufacturing process development, transfers, validation or analytical development and quality management In-depth knowledge of global pharmaceutical legislation specifically linked to regulatory CMC aspects in the ICH countries Position may require both domestic and international travel Qualification: Degree in Pharmacy or Life Science, Medical, PharmD or related discipline (minimum MPharm or MSc or equivalent degree), higher degree preferable (eg PhD in a scientific discipline) Experience Required: More than 7 years of overall work experience in Pharma environment, Competent authority or Academia/R&D experience related to the role Minimum 3 years of Global CMC regulatory experience User has advanced skills with all standard MS office and business applications (word, excel, power point, MS project, outlook, skype, SharePoint) User has contributor level of experience with RIMS / Veeva and EDMS RA application Key Skills: Experience in Regulatory Affairs CMC activities of Biologics / Biosimilars / Injectables is an added advantage to this position Experience in preparation and management of regulatory CMC documentation, including normally a full international submission (new product application) or complex variations Experience with life-cycle management activities in at least two regions (eg Europe, USA, International would be an asset) Experience with ROW countries and awareness of regulatory affairs CMC contribution to Pharma business Depth knowledge in Regulatory Affairs and experience of working in a global regulatory environment including exposure to registration procedures (CP, MRP, DCP, National etc) and LCM strategies Communication and Collaboration: Excellent written and spoken English language