医療開発本部レギュラトリーアフェアーズジャパン CMC薬事ノンラインマネージャー

Basic purpose of the job

The manager of RRL JP CMC has responsibility to develop and implement regulatory strategy for the assigned products/projects as LRL, and exercises activities which include:

1) An integral member of the Regulatory Excellence Team, contact point of GRLs for CMC related matters, and contributes to the delivery of robust regulatory strategies and coordination of local regulatory activities for the assigned development projects and marketed products for Japan to enable timely submissions and approvals.

2) Interface & contact partner for the Japanese regulatory authorities for development products including those undergoing PMDA Consultation as well as marketed products, Global RA and other cross-functional stakeholders for product and project related regulatory activities for CMC related matters (including Master File).

3) Regulatory expert for the regulatory requirements for CMC matters in Japan.

Support Head of CMC RA regarding specific projects and activities.

Act as LRL and/or contact point of GRLs for assigned projects/products, registration submissions and Regulatory Compliance, and be a trusted partner to health authorities as well as BI.

Accountabilities

1. Regulatory Strategy and Registration Activities

1.1 An integral member of the Regulatory Excellence Team, contact point of GRLs for CMC and Regulatory Compliance related matters, and contributes to the delivery of robust regulatory strategies and coordination of local regulatory activities for the assigned development projects and marketed products for Japan to enable timely submissions and approvals.

a. Actively participate in Regulatory Excellence Team meetings and discussions, providing GRL with Japanese regulatory advice and updates. Supports GRL with the local aspects for the generation of Regulatory Status Updates, management briefings (Product Update Reports) as well as pre-reads and presentation at the Regulatory Expert Group (REG).

b. Provide Japanese CMC regulatory input and guidance, ensures local requirements and agreed strategy are addressed in the submissions including expedited regulatory pathways if available

c. Identify, investigate and recommend solutions to potential CMC regulatory challenges during product lifecycle including product defense & benefit / risk assessments.

d. Coordinate, plan and conduct formal / informal meetings and teleconferences with regulatory authorities in Japan in cooperation with GRL and relevant stakeholders as appropriate. (CMC matters).

This includes the lead of preparation of the relevant briefing packages in cooperation with GRL and required stakeholders.

e. Provide guidance and contribute to the strategy and content of local labels for original submissions and product lifecycle management as appropriate. (CMC matters)

f. Deliver robust CMC regulatory strategies for the Japanese regulatory documentation (e.g. Clinical Trial Notifications, local dossier elements for Marketing Authorization Applications and life cycle management).

Generate, provide and manage the application form (FD format) for all types of submissions including Master File.

g. Lead the provision of responses to local Health Authority questions from Japan. Contribute to response strategy in cooperation with GRL and other stakeholders. Submit responses to the Japanese health authority questions. (CMC matters).

h. Support timely submissions to the Japanese regulatory authorities in accordance with the defined submission plans in collaboration with GRL and RA sub team and other stakeholders. (CMC matters).

1.2 Interface & contact partner for the Japanese regulatory authorities for development products including those undergoing PMDA Consultation as well as marketed products, Global RA and other cross functional stakeholders for product and project related regulatory activities for CMC matters:

a. Contact partner for GRA functions on regulatory requirements for Japan and their interpretation for product and project related regulatory activities for the assigned projects/products.

b. Ensure outcome of important agency meetings / regulatory procedures are communicated to GRL and other relevant stakeholders, as appropriate. (CMC matters).

c. Provides regulatory input for Japan to Regional Clinical Development as appropriate and in alignment with the global regulatory strategy and the GRL. (CMC Matters).

1.3 Completion of new labeling for product launches and revisions for product maintenance, efficiently and accurately. (CMC Matters)

• Management of Launch, change and discontinuation of BI products through the corporate system Go-Track/SLCI/CPD3.

1.4 Act as contact point of GRLs for CMC, related matters, member of Regulatory Excellence Team (RRL JP CMC or LRL) for assigned products/projects, where applicable.

Related performance indicators

1.1a. Provision of Japanese input.

1.1b. CMC Regulatory Strategy and requirements delivered to GRL.

1.1c. Strategy defined and delivered to relevant stakeholders.

1.1d. Agency meetings are prepared and conducted as agreed.

1.1e. Contribution and guidance provided.

1.1f. Timely definition and review of documents.

1.1g. Timely submission of responses to local Health Authority questions.

1.1h. Timely submission to regulatory authorities.

1.2a. Provision of regulatory requirements and relevant interpretations.

1.2b. Communication of outcome of the agency meetings / regulatory procedures.

1.2c. Regulatory input provided to Regional Clinical Development Japan.

1.3 On time work items as per agreed timelines.

1.4 Refer to Job profile Regional Regulatory Lead CMC Japan (RRL JP CMC).

2. Regulatory Intelligence.

2.1 Active contribution to evaluate 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 CMC related regulatory requirements in Japan

a. Develop and promote regulatory intelligence for CMCRA and Regulatory Compliance in 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 sub teams 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.

Related performance indicators

2.1 Contribution to review and implement new process affecting regulatory compliance.

2.2a. Provision of CMC and regulatory compliance related intelligence for Japan to relevant stakeholders as appropriate.

2.1b. Knowledge shared within organization, e.g. via touchpoints.

2.1c. Support of provision of Regulatory Intelligence Alert forms and impact assessments.

3. Quality and Compliance

3.1 Adhere to BI/internal compliance rules.

3.2 Attend and contribute to GMP or other regulatory inspections.

3.3 Identify and assess topic affecting regulatory compliance.

Related performance indicators

3.1 BI internal compliance KPIs fulfilled and regulatory databases maintained and updated according to GRA timelines.

Conducted document QC to make sure the regulatory compliance of registration dossier, and no gap between the registered and source document.

3.2 Evidence of timely authority interaction / submissions. Evidence of change control implementation documented. GMP documentation provided to regulatory authorities. Comments to inspections reports coordinated and communicated to regulatory authorities. Inspection findings communicated within organization.

3.3 Issue is brought proactively to management in need.

4. External Relationships and Engagement.

Lead regulatory activities and act as LRL or contact point of GRLs (where applicable) for CMC and other registration submissions to…

4.1 Pro-active contribution in local pharma network/trade association meetings and feedback on upcoming and current public consultations and position papers (where possible).

Related performance indicators

4.1 Participation of external meetings and interactions.

5. Training and Talent Management

5.1 Support Head of CMC RA in training and talent management.

Related performance indicators

5.1 Support provided to creating training plan.

6.Involvement in Business Platforms.

6.1 Actively participate and contribute to different business forums.

Related performance indicators

6.1 Contribute business forums on local level (e.g. HPMC, etc.)

7. Lead/Engage in Cross-functional collaboration.

7.1 Be a valued partner to other functions in HPBU..

7.2 Provide input for Brand team strategy.

7.3 Supporting products' access to the market.

7.4 Continuous alignments with supply chain to ensure seamless product supply.

Related performance indicators

7.1 Lead/Engage in cross-functional collaboration and make sure that all relevant stakeholders are timely, and proactively updated on relevant RA topics.

7.2 Brand Team: Communicate effectively brand strategy and development of RA complementary strategy.

7.3 Market access: Effective communication of product value proposition to the external RA stakeholders. Contribution to the local market access strategy and activities.

7.4 Supply Chain: Ensure the existence, active participation and effective knowledge sharing of RA teams in cross-functional platforms to ensure no supply interruption due to RA issues. Support efficiency business projects.

8. Managerial activities

8.1 Estimate budget planning for assigned projects.

8.2 Top-Management updates, including participation in decision-making committees for CMC RA related topics (e.g. MLT, HPDC, HPMC, or BIJEC).

8.3 Contribute to individual working groups upon special assignment.

8.4 Support Head CMC RA regarding specific projects and activities.

Related performance indicators

8.1 Estimated proper budget for assigned projects.

8.2 Coordinate and review meeting materials and ensure availability in time. Participation in decision-making committees.

8.3 Provide deliverables to working group or task team within agreed timelines.

8.4 Provide deliverables within agreed timelines.

Regulatory and / or Organisational Requirements

• Labor Standards Act, Act No. 49 of April 7, 1947.

• Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (The PMD Act), Act No. 145 of August 10, 1960.

• Follows government regulations and company standard operating procedures relevant to quality management system (QMS), quality assurance(GQP).

• Be compliant and acts within ethics at all times.

Job Complexity

The position requires the ability to prioritize 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.

Interfaces

Direct reports:0

Functional reports:0

Total reports:0

Internal interfaces:

Information exchange and dialogue with functions within Japan: Regulatory Affairs, Medicine, CMC experts KPRI, Legal HP Supply and Marketing Supervisor General Office.

Information exchange and dialogue with global functions: Global Regulatory Affairs, International Project Management, Research and Development, Medicine, Pharmacovigilance, QM, Clinical Operations, Operations and Global Quality.

External interfaces:

Dialogue and negotiations with Health Authorities, Industry Associations, and License partners as required.

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.

Job Impact

Ensure local requirements are known to the relevant stakeholders.

Minimum Education/Degree Requirements

Bachelor degree in Pharmacy, life sciences, chemistry, or significant practical experience related to CMC.

Further degrees, e.g. Specialized Pharmacist or Master of Drug Regulatory Affairs are appreciated.

Required Capabilities (Skills, Experience, Competencies)

Knowledge:

• In depth knowledge of international regulatory requirements, including understanding, interpretation and application of the regulatory legislation in Japan.

• Excellent knowledge of and adherence to relevant internal processes and procedures.

• Good knowledge and understanding of regulatory activities associated with all types of drug development, registration and maintenance of approval drug products.

• Good knowledge and experience with managing licenses for marketing authorization holder, manufacturing authorization and wholesaler.

• Good understanding of labeling on packaging.

• Good knowledge and experience with drug development, marketing authorization applications and maintenance of marketing authorizations.

• Good understanding of chemical-pharmaceutical, medical subjects as well as of pharmacovigilance and labeling requirements.

• Well understanding of environment and trend of health authority.

Professional skills:

• Capable to provide the leadership to develop and implement solutions to complex problems.

• Unbiased international view and inter-cultural competence.

• Open minded, motivating personality with drive and initiative.

• Willingness and ability to create and share knowledge.

• Critical thinker with ability to self-manage workload, including reprioritizing and delivery under tight timelines.

• Ability to work well under pressure, influence without authority, good interpersonal and negotiation skills.

• Team player, flexible and willingness to adapt in a changing environment.

• Excellent oral and written communications skills.

Experience:

• More than 3 years’ experience in RA including new drug registration.

• More than 3 years’ experience in R&D and/or Medical development.

• Practical experience in handling new developments, registrations and maintenance of Marketing authorizations.

• Experience with direct Health Authority interactions.

• Preferably international work experience.

Language skills:

• Japanese: Fluent

• English: Excellent in communicating in English

All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.