JOB PURPOSE
The CHC Regulatory Affairs Head is a Regional role with responsibility for the Regulatory Affairs strategy & execution for a Region while ensuring adherence and compliance with our global regulatory affairs strategy, governance and ways of working. The role will be responsible for ensuring regulatory Affairs strategy (including brand regulatory strategy, CMC & label compliance, regulatory intelligence & future facing strategy, regulatory compliance) for Regional Local Brands in addition to execution of Global Brand plans for their Region.
The regional brand portfolios range from 60 – 80% of the total business and this Medical Affairs Regional Head will be responsible to deliver regulatory affairs strategy for this portfolio of brands driving growth end to end through innovation and protection base business. The remaining 20 – 40% of efforts will be to execute on global brand strategy for the region partnering with global brand R&D leads
The Regulatory Affairs Head has final authority for the strategic development, design, planning and delivery of regulatory approach to engage with health authorities and ensure compliance for the CHC products in the Region. Decisions on planning and execution of Scientific publications, Medical Information activities regionally as well as strategic support for claims generation fall in that person’s area of responsibility. The Regulatory Affairs Head’s scope of responsibilities includes all CHC products in the Regional under development and marketed products with a strategic role in local brands and execution role for global brands.
The role is accountable to ensure compliance with Global Regulatory Affairs organization, systems and procedures in the CHC organization, including collaboration with HCPs, vendors, CRO or service providers in case some specific tasks are subcontracted for the Region. The role is expected to work closely with Regional Brand R&D leads, Regional Medical Affairs Head, Regional Quality Head, Regional PV Head to ensure one science hub voice and hold their teams accountable for decision making & risk taking for our Regional Brands. The role is expected to be able to priorities & balance activities across innovation projects and base business, and advocate/drive for Regional Brand needs within Global Regulatory Affairs organization
Reporting directly to the Regional SH Head, the Regional Regulatory Affairs Head is a member of the CHC Regional Science Hub Leadership Team. He/she interfaces with other senior leaders of the CHC regional organization, to develop the Regional Regulatory Affairs strategy and vision that support key business priorities. The Regional Regulatory Affairs Head is a senior leader in the global Regulatory affairs organization and is expected to have an active role in the overall CHC Regulatory Affairs strategy, plans and delivery
KEY RESULTS/ACCOUNTABILITIES
The Regional Regulatory Affairs Head is accountable to delivers Regulatory Affairs strategy for Regional brands and to execute on global brand plans in the Region. He/she also ensures that regulatory strategies are based on deep knowledge of health authority guidelines, and can guide team to deliver against data driven strategy. The role is accountable for meeting all regulatory requirements in scope in the region.
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KEY WORKING RELATIONSHIPS
SKILLS, EXPERIENCE & KNOWLEDGE REQUIREMENTS
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