Regulatory Manager

Job title: CMC Regulatory Manager

• Location: Hatsudai, Tokyo

About the job

Role & Responsibilities

The incumbent regulatory professional is accountable for Japan strategic management of a portfolio of development projects and post-marketed products within Global regulatory CMC & Devices Japan. The incumbent is responsible for Japan regulatory CMC strategies, submission dossiers and approvals, including direct contact/liaison with PMDA/MHLW, for development phase of projects and for Change Controls. The incumbent creates collaborative working relationships with Global Regulatory CMC&D Focal Points (FP), Japan Regulatory Group, Technical and Quality Groups within R&D and Manufacturing and Supply (M&S), Regulatory Health Authorities, Others. The incumbent is also engaged in internal and external Regulatory Policy Organizations/Programs/industry association group in order to develop and maintain appropriate Sanofi representation in these activities. The incumbent demonstrates behaviors that live and promote the Sanofi and GRA Values/Principles/Competencies.

1.       Develops innovative Japan regulatory CMC strategies and risk assessments for development projects in collaboration with Global Regulatory CMC&D FP and/or other stakeholders.  Assures that positive and collaborative relationships are developed with CMC teams to achieve the implementation of appropriate regulatory strategies.  Assures that, for major CMC activities that have a critical regulatory and/or financial impact, appropriate strategies are developed to manage the activities, and risks are identified, communicated and mitigated as necessary.  Contributute to the Global Regulatory CMC Strategy Document (GRSCD) to ensure that Japan regulatory requirement/target profile is adapted into the global CMC development.

2.       Assures that appropriate contacts with Health Authorities (PMDA/MHLW), in collaboration with Japan regulatory group , are initiated and addressed in an effective and timely manner, whilst developing positive and favorable relationships.  Responsible for direct contact/liaison with PMDA on specific CMC topics.  Led PMDA quality consultations and other CMC focused regulatory meetings in collaboration with Global regulatory CMC&D FP and other R&D/M&S CMC functions.   Manages and directly contributes to HA meeting briefing documents in collaboration with global regulatory CMC FP, Global CMC Dossier, and other related CMC functions.  Supports strategic negotiations with Japanese Health Authorities so that appropriate and pragmatic positions are negotiated with acceptable Probability of Success (POS).

3.       Manages post-marketed CMC change controls for the assigned product(s).  Conducts regulatory impact assessment in timely manner, and provide Japan regulatory strategy for these changes that requires regulatory actions.  In close collaboration with Japan post-marketed regulatory group, utilizes HA meetings/cunsultations as appropriate to develop suitable regulatory strategy that meets current local regulatory expectations as well as business needs.  Collaborate closely with global/local M&S functions and Japan post-marketed regulatory group to prepare dossier package suitable for regulatory submissions.  Manages and directly contributes to the CMC responses to regulatory inqueries in collaboration with Global regulatory CMC&D FP and M&S site SMEs.

4.       Manages and directly contributes to the CMC writing, preparation, review and approval of regulatory CMC dossiers for submission in collaboration with global CMC Dossier, M&S Functions and GRA Regulatory Operations.  Explores opportunity for efficiency improvement in the dossier preparation process and takes actions to promote new ideas.  Assures that submission dossiers meet appropriate quality standards; strategies and mitigated risks are developed and communicated, and deadlines are achieved.  Assures that technical and regulatory CMC issues are appropriately resolved with optimal solutions.  Manages and directly contributes to the CMC responses to regulatory inqueries in collaboration with Global regulatory CMC&D FP and Japan regulatory group as well as global CMC Dossier and other CMC SME functions.  As requested by M&S/R&D quality organization, may support  the regulatory inspection process (PAI) for development projects as a local GMP sub team lead.

5.       Develops CMC technical skills/knowledges including new technological platforms as appropriate.  Contributes to the global RCMC topic leader community.  Contributes knowledge and expertise on GRA Regulatory Science and Policy activities, as well as other related internal or external policy initiatives, in order to assure that appropriate Sanofi visibility and input is recognized.  Monitors the review of local and international Health Authority regulations and guidelines, contributes to the commenting process and/or develops position papers.  Assures that current Health Authority thinking and trends (paradigm shifts) are understood and broadly communicated.

Impact range

・RA-J, RCMC-J, projects/products, Global, industry associations (partially)

Impact level

・As an expert in RCMC area, Carries out the tasks independently, Influences internal stakeholders, and Contributes to achieving the goals and improving performance and productivity of the RA-J and RCMC.

About you

Knowledge, Skills & Competencies / Language

Global operational experience with a mid/large-size Regulatory CMC and Devices Organization.  Must have knowledge of Japan & global regulations/guidelines, key Health Authority/Industry thinking and trends, and be capable of resolving strategic technical and regulatory issues.  Knowledge of Japan regulatory dossier requirements and dossier preparation experience.  Should demonstrate initiative, some independent thinking, anticipatory foresight, and be able to communicate effectively to internal and external audiences.   Business level of English fluency (oral and written) is essential.  Potential to be able to mentor and train staff is a plus but not essential.

Qualifications

Minimum of a Bachelor’s Degree; advanced degree (Masters, PhD) in a science/health field (eg, Analytical, Chemistry, Pharmacy, Biological/Biotechnology Sciences etc.), or equivalent,  is desirable.

Technical pharmaceutical CMC experience (QC laboratory, manufacturing, etc.) is desirable.

Typically, an additional minimum 3 years of direct Regulatory CMC experience is preferred.   However more than 5 years may be applicable for certain associates within an individual contributor career path.  Experience working for a Regulatory Health Authority is helpful but not essential.