Chc Regulatory Affairs Senior Manager Japan Jobs Vacancy in Sanofi
Sanofi urgently required following position for Chc Regulatory Affairs Senior Manager Japan. Please read this job advertisement carefully before apply. There are some qualifications, experience and skills requirement that the employers require. Does your career history fit these requirements? Ensure you understand the role you are applying for and that it is suited to your skills and qualifications.
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Chc Regulatory Affairs Senior Manager Japan Jobs Vacancy in Sanofi Jobs Details:
The Regulatory Affairs (Senior) Manager - Japan is responsible for, ensuring compliance of the existing Consumer Health Care (CHC) portfolio under assigned scope, effective and timely approval of all marketing authorizations, maintenance, provide appropriate input on the development of new products and shape the regulatory environment, and possibly leading a sub-team.
Must speak English fluently. TOIEC over 800
Department: Regulatory Affairs
Division: Consumer Health Care (CHC)
Reports to: Solid line: CHC Regulatory Affairs Country Head
Specific requirements and responsibilities include:
- Assists with setting the vision and local RA priorities for portfolio under scope aligned with the business priorities
- Ensure development of team members, if any, and coach them
- Contribute to RA strategies by providing proactive RA support taking into account local RA requirements and local business needs.
- Ensure advice and input is provided to local business strategies with regards to regulatory feasibility, requirements and timelines.
- Assist in managing the local RA budget in collaboration with the Finance Department.
- Advise on resource capacity for performing required regulatory activities.
- Ensure high quality submissions within timelines agreed with GRA, business and/or health authorities.
- Lead motivate and develop regulatory staff under scope, if any, and ensure they maintain and develop their regulatory skills and keep up-to date with the regulatory environment by appropriate trainings.
- Ensure embedding of a CHC mindset
- Ensure product packaging and associated information are updated, timely implemented and maintained in accordance with the current product licenses.
- Ensure that Marketing Authorizations are updated in line with Company Core Safety Information according to Corporate requirements
- Ensure adherence to GRA mandatory SOPs and training, and support the development of appropriate ones if not available yet
- Ensure quality and compliance of local regulatory activities in line with corporate regulatory affairs, national regulations. Ensure maintenance of regulatory databases.
- Actively follow the development and emergence of new regulatory requirements and assess their impact on the existing products and in development.
- Review and approve promotional and non-promotional materials ensuring their compliance with local regulations, code of conduct and internal guidelines. Coordinate review with the responsible functions in the country.
Health Authority Interactions:
- Support the GRA CHC Country Head to act as the primary interface between the company and local regulatory authorities.
- Build good relationship, making Sanofi a recognized partner with the agencies
Regulatory Environment influence
- Shape the country Regulatory environment through active contribution in Regional industry associations and in collaboration with Public & Government Affairs
Management of portfolio under scope:
- Lead the management of the local maintenance activities and ensure compliance of the marketed product portfolio
- Lead development of the Local Regulatory strategies
- Manage with other functions the preparation of local dossiers for the products under development and territory extensions
- Lead development of local strategies and preparation of local OTC switches
- Ensure that best efforts are provided to get timely approvals of dossiers
- Give Input to GRA for drug development with regards to local needs (labelling, clinical trials)
- Support the local CSU organization in approval procedures for clinical trials.
- Co-ordinate the local health authority approval and implementation of risk management plans and DHPCs and educational material.
- Ensure public availability of current approved product information for risk minimization (SmPC, educational material, PIL, compendia)
Provide RA input to product portfolio optimization and product pruning at affiliate level and
give RA input to global product portfolio optimization strategies.
III – COMPETENCIES AND SKILLSET
Special Knowledge & Qualifications
- Excellent understanding of the consumer healthcare and pharmaceutical industry, drug development environment, and R&D processes and objectives
- Expert knowledge of consumer healthcare regulations and requirements, HA regulations and ability to evaluate impact of those regulations within the drug development environment and to lead discussions of the requirements and its impacts within submission teams
- Fluent spoken and written English: For Japan: TOIEC over 800
- Lead teams
- Develop people
- Act for Change
- Cooperate Transversally
- Strive for Results
- Commitment to Customer
- Think Strategically
- Make Decisions
- Team collaboration
- Strong interpersonal/communication skills
- Ability to work in a matrix environment. Japan: ability to interact effectively with regional and global internal stakeholders, skilled in working in a cross-cultural environment
- Business acumen and customer orientation
- High standards of integrity
- Ability to develop strong networks and influence internal and external stakeholders
- Minimum MS; Pharm D, MD, PhD or equivalent preferred
- Minimum 5 years in Regulatory Affairs
- Experience in in managing matrix teams
- Preferred: Demonstrated ability to independently lead teams and implement operational regulatory excellence
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.