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Basic purpose of the job

The manager of RRL JP provides strong leadership to develop and implement regulatory strategy for the assigned products/projects as RRL JP, and exercises activities which include:

An integral member of the Regulatory Excellence Team, a contact point of Global Regulatory Lead (GRL), responsible for a particular therapeutic area(s), contributes to the delivery of robust regulatory strategies, leads task team for J-CTD, and coordinates local regulatory activities for the assigned development projects and marketed products for Japan to enable timely submissions and approvals.

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 the assigned therapeutic area(s).

Regulatory expert for the regulatory requirements in Japan.

Support Head of Development RA regarding specific projects and activities..

Act as Regional Regulatory Lead Japan for assigned products/projects and be a trusted partner to health authorities as well as Boehringer Ingelheim.

Accountabilities

1. Regulatory Strategy and Registration Activities.

1.1 An integral member of the Regulatory Excellence Team, responsible for a particular therapeutic area(s) 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 regulatory input and guidance on development needs such as the need for inclusion of special populations into clinical trials, required subgroup analyses and ensures local requirements and agreed strategy are addressed in the submissions including expedited regulatory pathways if available. Supports the GRL with the local aspects for the Global Regulatory Strategy document.

c. Identify, investigate and recommend solutions to potential 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. 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.

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

Generate and provide local regulatory documentation e.g. local regulatory statements in cooperation with GRO as appropriate.

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.

Related performance indicators

1.1 a. Provision of Japanese input.

1.1 b. Regulatory Strategy and requirements delivered to GRL for inclusion in the global regulatory strategy as appropriate.

1.1 c. Strategy defined and delivered to relevant stakeholders.

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

1.1 e. Contribution and guidance provided.

1.1 f. Timely definition and review of documents.

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

h. Lead task team for J-CTD and execute timely submissions to the Japanese regulatory authorities in accordance with the defined submission plans in collaboration with GRL, Regulatory Excellence Team and other stakeholders.

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 the assigned therapeutic area(s):

a. Contact partner for GRA functions on regulatory requirements for Japan and their interpretation for product and project related regulatory activities for the assigned therapeutic area(s).

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

c. Provides regulatory input for Japan to Regional Clinical Development as appropriate and in alignment with the global regulator

1.3 Completion of new labeling for product launches, efficiently and accurately.

1.4 Act as member of Regulatory Excellence Team (RRL JP or LRL) for assigned products/projects, where applicable.

Related performance indicators

1.1 h. Timely submission to regulatory authorities.

1.2 a. Provision of regulatory requirements and relevant interpretations.

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

1.2 c. 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 Japan (RRL JP).

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 Act as Subject Matter Expert for the regulatory requirements in product development in Japan

a. Provide information related to TA specific regulatory Intelligence for Japan.

b. Promote the knowledge of the regulatory landscape and regulatory requirements in Japan within the Boehringer Ingelheim organization in collaboration with RET and any other relevant function as appropriate.

c. Provide support for Regulatory Intelligence Network process by compilation of Regulatory Intelligence Alert forms and impact assessments to ensure transparency and awareness with the Boehringer Ingelheim organization on the magnitude of the impact for implementation.

Related performance indicators

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

2.2 a. Provision of TA specific regulatory intelligence for Japan to relevant stakeholders as appropriate.

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

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

3. Quality and Compliance

3.1 Adhere to Boehringer Ingelheim/internal compliance rules.

3.2 Attend and contribute to GCP, PV, or other regulatory inspections.

3.3 Identify and assess topic affecting regulatory compliance.

Related performance indicators

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

3.2 Evidence of timely authority interaction / submissions. Evidence of safety label implementation documented. GCP 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

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).

5. Training and Talent Management

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

Related performance indicators

4.1 Participation of external meetings and interactions.

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 Human Pharma.

7.2 Provide input for Brand team strategy.

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.

8. Managerial activities

8.1 Estimate budget planning for assigned projects.

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

8.3 Contribute to individual working groups upon special assignment.

8.4 Support Head of Development 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

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

• Be compliant and acts within ethics at all times.

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.

Interfaces

Direct reports: 0

Functional reports: 0

Total reports: 0

Internal interfaces:

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

Information exchange and dialogue with global functions: Global Regulatory Affairs, Corporate Medicine and Asset Team and Global Quality.

External interfaces:

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

Job Expertise

Provides 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 or Master degree in Pharmacy, Chemistry, Biology, Biochemistry, Biotechnology, Technology or Agriculture with significant practical experience related to respective TA.

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 the drug development process.

• 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 labelling 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 5 years’ experience in RA including new drug registration.

• More than 5 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.

• Track record in filings of Clinical Trial Notifications, Marketing Authorization Applications (J-NDAs), Partial Change Applications (J-sNDA) or related regulatory applications.

• Preferably international work experience.

Language skills:

• Japanese: Fluent

• English: Fluent

Recruiter : Ohsono

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.