Senior Specialist - Global CMC Regulatory

• 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