Job Summary

With emphasis on development and regulatory life cycle management, RPMs provide regulatory procedural support and guidance to assigned projects for all regulatory pre- and post-authorisation activities in a manner that is scientifically sound, commercially viable and in accordance with regulatory standards.

In this role, RPMs ensure a smooth run of regulatory procedures as well as regulatory compliance. The support is directed towards Regional Strategists and Global Regulatory Leads (GRLs) for their designated projects and activities. Involves working closely with Regulatory Strategy, RA Affiliate Management, Labelling, Regulatory Operations, license partners, external vendors and others to support procedural delivery of the projects. Represent RA and/or DSE in internal and external interactions (e.g., project and working teams, affiliates, license partners, authorities, industry associations). Lead or support projects to enhance the functionality and improve processes of the organization and/or to adapt to a regulatory environment ("non-project projects"). The primary objective of the RPM is to ensure the successful and timely achievement of regulatory project milestones and deliverables. 

The RPM contributes to the development of the RPM group by sharing best practices and swiftly resolving process and operational challenges. Additionally, the RPM focuses on the continual enhancement of RPM processes, prioritizing quality, reliability, consistency across projects, and efficiency.

Responsibilities

Regulatory Procedures

• Responsible for assigned regulatory projects and “non-project” projects.
• As assigned, represent the region in global regulatory and development teams and provide regulatory procedural guidance and operational strategy for assigned projects
• Work closely with EU Regulatory Project Manager and Dossier Planner agreeing delivery timelines, planning and tracking.
• Liaise, negotiate and communicate with functional groups within Daiichi Sankyo, corporate partners, RA affiliates and agencies to obtain and/or provide information/data for regulatory submissions.
• Serve as a link between Regulatory Strategy, RA Affiliate Management, Labeling and other disciplines in RA (e.g. RA-CMC, Regulatory Operations).
• Support the GRL global operations and the running of the GRT, including coordinating GRT meetings, preparing agendas and tracking action items. They also help the GRL in managing the overall global project plan for an asset.
• Support Regional Strategists in developing regional strategy and inputting into GRT. They also provide assistance in managing regional project plans for an asset.

Responsibilities Continued

• Provide support or coordinate other regulatory activities per direction from GRL and Regulatory regional Strategists (e.g. regulatory input to a Development Safety Update Report [DSUR]).
• Support internal communications on regulatory status for the assigned assets. Participate in assigned “non-project” tasks to enhance the operations and processes of Regulatory Affairs.
• As assigned by superior, act as the regulatory contact person for procedural aspects
• Ensure consistency across projects and alignment/synergies.

Regulatory Submissions Involvement

• Involved in the development of major submissions, as well as routine/lifecycle submissions
• Working closely with regulatory project manager and when assigned dossier planners to plan, lead and support assigned regulatory submissions during development and life cycle management
• To advise on submissions and evaluate the content and adequacy of regulatory submissions; identify deficiencies requiring further resolution.
• Be directly responsible for on time delivery of regulatory submission
• Prepare gap analysis of documentation vs regional and global requirements in alignment with regional strategists (for example regional adaptation for module 2-5).
• Coordinate preparation of and prepare regulatory documents, when required, for submission, review RA and related documents from procedural perspective for sign off prior to submission.
• Working closely with EU regulatory project manager and when assigned dossier planners to manage activities required for timely and accurate submission and tracking and reporting of submissions.
• Responsible for planning, coordinating and reviewing regulatory submissions in collaboration with the GRL, Regulatory Strategists, Regulatory Lead, Regulatory Operations (RO), and other key stakeholders (e.g. Protocol Amendments, Form 1572s, Information Amendments, Meeting Requests/Background Materials, DSUR, IND/NDA/BLA annual reports, BTD request etc.)
• Develop Module 1 regulatory documents (e.g. cover letter, Health Authority forms, administrative information, letter of authorization, etc.) for regionally specific regulatory submissions, support regional strategists for complex regulatory documents
• Working closely with regulatory project manager and when assigned dossier planners support submission planning, including establishing Kick-off meetings, developing project milestones, creating and updating records and setting up submissions content plans (SCPs)
• Responsible for maintaining global health authority query tracker (HAQ)
• Involved in managing health authority responses to submissions, which may include assembling a rapid response team (RRT)

As assigned by superior, act as regulatory contact person for authorities:

• Plan, liaise, negotiate and orchestrate meetings and teleconferences with regulatory authorities
• Initiate contact with regulatory authorities
• Support or lead negotiations on Regulatory issues with regulatory authorities

Continuing Education

• Keep current with, review and interpret regulatory and scientific regulations, directives, guidelines and initiatives.
• Communicate important changes and trends within RA and other functions when relevant. Design and revise SOPs and SOIs if required.

People Management

• Mentor and provide guidance to RPM Associates, including peer review of activities.
• Plan, assign and direct work; manage competing priorities as appropriate.

Qualifications

Education Qualifications

• Bachelor's Degree preferably in a scientific discipline required
• Advanced degree E.g., Masters, Pharm.D., Ph.D., MD, JD; a TOPRA diploma or Master Degree in Regulatory Affairs or further pharmaceutical specialization preferred
• Post-doctorate or professional experience in pre-clinical research or clinical development preferred

Experience Qualifications

• 4 or more years experience in regulatory affairs with an emphasis on regulatory pre-submission and post-approval activities and preparation of new Marketing Authorization preferred
• 1 or more years industry experience (within regulatory is preferred) required
• Deep knowledge of laws, regulations, guidelines and other requirements for human medicinal product marketing authorization and maintenance is essential Experience in paediatric development is a plus. preferred

Physical Requirements

• Ability to perform computer tasks for several hours at a time 60%% of the time.