Senior Specialist _ Regulatory CMC

Your Role:

• To provide end-to-end support for Annual Reports and Renewals for all products, e.g. planning of required activities, attend kick-off/jour-fixe meetings, contribute to DSP and ensure timely collection of respective requirements and deliverables Update and review CMC specific documentation, incl. coordination with countries to compile local CMC variations.
• Conduct change control regulatory assessment for multiproduct site changes, incl., updating the CCP tracker, and performing required notifications.
• Management and responsibility of assigned CMC Regulatory activities and projects. Examples for these comprise answers to Health Authority queries, life cycle management submissions, marketing authorization applications wherever applicable.
• Accountable and responsible to provide country specific CMC regulatory requirements for dossier strategies and plans in close collaboration with other GRA functions. This includes assessment of Change Control Proposals for their regulatory impact worldwide to ensure that for each change control proposal, the regulatory implications have been considered.
• Accountable and responsible for global CMC-part of the regulatory strategy (RSD and DSP). This encompasses risk assessment, strategic support and advice.
• Review study protocols and reports, as well as other relevant technical documents intended for the product documentation platform or for local submission to confirm alignment of the report conclusions with the CMC Dossier Strategy and Plan.
• Accountable and responsible to confirm alignment between CMC dossier strategy and CMC regulatory documents before approval regarding fit to strategy, gaps, issues, risks and mitigation measures (within Dossier Generation Team).

Who You Are:  

Basic/ Minimum Qualifications:

• Degree in Pharmacy or Life Science, Medical, PharmD or related discipline (minimum M. Pharm or MSc or equivalent degree), higher degree preferable (e.g. PhD in a scientific discipline)
• Minimum of 7+ years of overall work experience in Pharma environment, Competent authority or Academia/R&D experience related to the role.

Preferred Qualifications: 

• Degree in Pharmacy or Life Science, Medical, PharmD or related discipline (minimum M. Pharm or MSc or equivalent degree), higher degree preferable (e.g. PhD in a scientific discipline)

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's standards, "right first time. Profound knowledge of Company's systems and databases (APT, Trackers, RIMS/Veeva, EDMS). Familiar with Company's 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.

Communication and Collaboration: Excellent written and spoken English language. 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: 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. 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/registration types and related requirements. Understanding of Regulatory Agencies structure, processes and key personal as applicable. In 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. 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.
• 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 (e.g. Europe, USA, International would be an asset).
• 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.
• Experience with ROW countries a plus awareness of regulatory CMC affairs contribution to Pharma business.