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OBJECTIVES/PURPOSE
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
SKILLS And COMPETENCIES
Critical leadership capabilities
Responsibilities
1. Regulatory Planning
a) Regulatory Plan Development
Plan, review and recommend the best regulatory strategy for submissions, including regulatory timelines, during the planning phase for pipeline products of assigned portfolio based on regulatory expertise with country regulations & MOH processes.
Manage and ensure the country Regulatory Plans are in alignment with Product Teams & Area strategies, and the country’s business plan (3/1).
b) Process Management
i) Coordinates the process with other functional members, sites and corporate (Legal, Administration, etc.) to ensure timely availability of required documents for dossier preparation.
ii) Active participation in cross-functional teams within the local operating company (LOC) and provide regulatory expertise and insight to ensure regulatory timelines are met or improved.
c) Regulatory Tools
i) Timely update of all databases as per LOC regulatory plan
ii) Ensure data is complete and accurate and that the updates meet /or improve upon the established compliance metrics (i.e. outstanding submissions/approvals)
a) Dossier Preparation
Prepare a quality regulatory dossier and submit within the planned timelines.
Activities include:
b) Gain Regulatory Approval
Gain Health Authority approvals to meet product launch plans and ensure product maintenance.
Activities include:
c) Metrics Review
i) Prepare periodic Regulatory Report of actual submissions and approval and communicate to local management.
ii) Provide regulatory metrics on performance that are aligned with Area & GEM Regulatory Affairs criteria to measure regulatory performance to LOC, Area & Regional management.
3. Regulatory Compliance
a) Compliance Maintenance
i) Take appropriate actions to maintain all local marketed products in compliance with local and corporate regulatory requirements [eg. all aspects of labeling (Product Information and packaging development); label change management; chemistry and manufacturing commitments that are registered with the DRA]
ii) Conduct periodic compliance self-audit to identify potential compliance issues
iii) Take corrective actions plans based on regulatory audit findings
b) Good Regulatory Practices (GRP)
i) Develop, update and implement appropriate SOPs as required by the Global Regulatory Affairs policies (Regulatory Quality Systems), local regulations and acceptable Good Regulatory Practices.
4. Regulatory Influence
External
a) Regulatory Customer Relations
Establish relationship with key regulatory officials (throughout direct interactions, industry associations, etc.) to influence regulators to foster positive regulatory environment for business and research.
b) Regulatory Environment Changes
Keep updated with current local regulations and DRA organizational structure and potential changes that will impact the business environment, and communicate appropriately to involved or affected parties.
c) Influence Strategy
Supports the development and implementation of the established external regulatory influence strategy.
Internal
a) LOC Organisation
i) Learn and understand the local organization and functions.
ii) Build functional partnership and credibility to maximize regulatory value in support of business decisions.
iii) Recognized as a valued member of decision making process that has or potentially has regulatory involvement.