【Basic Purpose of the job】
The manager of Product and Labeling Group has different responsibility in the area of drug development, the law compliance, management and training. In this function, the role exercises activities which include:
・Provides strategic regulatory guidance to the Japan Clinical Development Team and other cross functional teams in Japan, challenge development programs scientifically and oversee all regulatory aspects through the early development phase of new medicinal product (new chemical entities or new biological entities with or without linked medicinal devices) and new indications as well as product maintenance and optimization (PMO) period; guide staff in the group on the development of investigational products towards submission, approval, and coordination of regulatory maintenance activities taking into account and being compliant to Japanese regulations.
・Provides leadership and strategic planning for the assigned projects/therapeutic areas (TAs) in order to ensure sound regulatory practices are integrated into international drug development programs.
・Develop package inserts based on CCDS and target product profiles for Japan, where applicable.
・Run Local Labeling Committee for NIPs and DIPs.
・Maintain Japan package inserts.
・Follow regulatory standards, provides analysis, advises on and implement regulatory strategies and departmental policies and utilize resources consistent with the overall goals and objectives of the RA Japan as well as keep up to date on developments in the assigned TAs from the regulatory, scientific and pharmaceutical perspective.
・The role has the overall regulatory compliance responsibility with Japanese regulations of the group's projects/ therapeutic areas. The role interacts intensely with other functions (e.g. Medicine, Pharmacovigilance, pre-clinical and KPRI’s departments, HP Supply, Legal, Communications) to assure a compliant release and drug distribution, the implementation of authority instructions based upon regulatory procedures, drug labelling obligations and others.
・Act as Regulatory Lead Japan for assigned products/projects and be a trusted partner to health authorities as well as BI.
・Contribute the development of staff members for their expertise, competencies and career plans.
■Accountabilities *
・1.Regulatory Strategy and Registration Activities.
Lead regulatory activities and act as the RRL JPs for the assigned projects of therapeutic areas (TAs) to…
1.1 Develop and implement regulatory strategies and provide regulatory advice to support assigned drug development projects and Product Maintenance Optimization strategies.
1.2 Provide input including review of global key regulatory documents (e.g. development plans, CTNs, labelling documents and others.).
1.3 Support regulatory maintenance authorization activities for marketed pharmaceutical products.
1.4 Attend key pharmacovigilance meetings to discuss appropriate regulatory measures for prevention of drug risk minimization strategies, prevention of therapy errors, and optimization of drug therapy, appropriate drug information and authority communication strategies.
1.5 Provide input and attend to various types of regulatory agency meetings including preparation of briefing documentation (e.g. EoP2, pre-JNDA meetings).
1.6 Execute the process labeling and/or prescriber guide generation, where applicable
1.7 Execute preparation and handling of regulatory applications including response cycles (e.g J-NDAs, J- sNDAs and CTNs).
1.8 Execute and provide input for timely risk/benefit analysis of topics affecting products and/or target product profiles of the projects by continued monitoring of available regulatory and competitor product information.
1.9 Ensure timely dossier tailoring, dispatch and submission. Archiving of local Regulatory submission documents.
1.10 Act as member of Regulatory Affairs sub team (RRL JP, RL JP or LRL) for assigned products/projects, where applicable.
・2. Regulatory Intelligence
Lead regulatory activities as the RRL JPs for the assigned projects of therapeutic areas (TAs) to…
2.1 Evaluate proactively relevant Japanese regulations and guidelines including drafts critically for company compliance to drug laws and determine impact on existing procedures.
2.2 Regulatory expert for the regulatory requirements in Japan.
a. Develop and promote TA specific regulatory Intelligence for Japan. Identify synergies, encourage and promote harmonization as appropriate within BI.
b. Promote the knowledge of the regulatory landscape and regulatory requirements in Japan within the BI organization in collaboration with RA Subteams and any other relevant function as appropriate.
c. Support of Regulatory Intelligence Network process by compilation of Regulatory Intelligence Alert forms and impact assessments to ensure transparency and awareness with the BI organization on the magnitude of the impact for implementation.
・3. Quality and Compliance
3.1 Adhere to BI/internal compliance rules.
3.2 Perform and implement authority instructions based upon regulatory procedures in order to assure and maintain the legal marketability of the groups Marketing Authorizations.
3.3 Provide high quality input and where appropriate attend ad-hoc meetings (eg. Management of non-compliance or complaint).
3.4 Attend and contribute to GCP, PV, or other regulatory inspections.
3.5 Monitor regulatory guideline developments and provide analyses of topics affecting regulatory compliance.
3.6 Perform RA tasks (e.g. participate Regulatory Subteams) for products/projects with a licensing partner as outlined in the licensing contract.
3.7 Review promotional material and distribution strategies with focus on drug information and promotion codes.
・4. External Relationships and Engagement
Lead regulatory activities as the RRL JPs for the assigned projects of therapeutic areas (TAs) to…
4.1 Manage close external relationships.
・5. Support for Local and Global Projects.
Lead regulatory activities as the RRL JPs for the assigned projects of therapeutic areas (TAs) to…
5.1 Provide regulatory strategic guidance and leadership to RA Team (where applicable).
5.2 Provide timely input to GRA on cross-functional issues impacting RA.
・6. Training and Talent Management
6.1 Support Head of Product and Labeling Group to train & develop group members.
・7. Involvement in Business Platforms
Lead regulatory activities as the RRL JPs for the assigned projects of therapeutic areas (TAs) to…
7.1 Actively participate and contribute to different business forums.
・8. Lead/Engage in Cross-functional collaboration.
Lead regulatory activities as the RRL JPs for the assigned projects of therapeutic areas (TAs) to…
8.1 Be a valued partner to other functions in Human Pharma (e.g. Market Access, Marketing, Medicine, PV, Legal, Supply Chain, QM, etc.), empowering them to understand the regulations and implications for their business area
Provide support and act as POC for clinical trial activities (where applicable).
8.2 Active contributor to the Brand team strategy. Active contributor in Business reviews.
8.3 Supporting products' access to the market.
8.4 Continuous alignments with supply chain to ensure seamless product supply.
・9. Managerial activities
9.1 Estimate budget planning for assigned projects.
9.2 Top-Management updates, including participation in decision making committees (e.g. MLT, HPDC, HPMC, or BIJEC).
9.3 Contribute to individual working groups upon special assignment.
9.4 Support Head of Product and Labeling Group regarding specific projects and activities.
・10. Foster culture of innovation.
Lead regulatory activities as the RRL JPs for the assigned projects of therapeutic areas (TAs) to…
10.1 Stimulate and encourage innovation in our daily activities.
【Job Complexity*】
The position requires the ability to priorities workload on a daily basis and maintain an up to date plan of ongoing and future work, to manage a heavy and varied workload with possible conflicting and changing deadlines and respond quickly and positively to changes, showing a flexible can-do attitude, to work independently and pro-actively but also to identify when additional support or input is needed.
【Job Expertise*】
In-depth knowledge in Regulatory Affairs gained through experience in serving as a local regulatory leader for multiple projects throughout development and product life cycles.
Provides strong leadership in guiding local regulatory leads or other teams.
■休日:完全週休二日制, 年末年始