CHC Regulatory Affairs Head - North America
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
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.
- Accountable to the Regional CHC organization for the Regulatory strategy that ensures risk-benefit profile for regional products & portfolio; this role is formalized as part of MLR process and team.
- Execute a Regulatory strategy to deliver to global brands working closely with global brand lead ensuring a strong pipeline of new claims, communications to drive growth and renovate existing products
- Be accountable to lead Regulatory strategies for regional brands through their team members, coaching and ensuring appropriate level of brand risk discussion and enabling a culture that empowers rapid go/no go decision making.
- Develop strong operational implementation plans to ensure high quality and timeliness of Regulatory affairs activities related to regional brands. Provide strategic direction for brands and ensure deliver to early ideation activities. Evaluate workload, quality and budget through regular analysis of data to ensure resource sufficiency versus workload.
- Forecast and manage budget and resources across sites for regional Regulatory affairs. Manage the resourcing process and outcomes (ensure fair balance between activities maintained internally and outsourced/offshored), to deliver on CHC organization objectives and to meet regulatory requirements.
- Drive best practice and innovation in Regulatory Affairs for the region, specifically to develop a vision for interaction with key health authorities. Work closely with public policy teams internally & externally to influence health authorities guided by our future strategy
- Drive an external network in the Region to ensure a strategy to enable future Regulatory trends; advocate & propose new capability within the region and global teams
- Lead a group of Managers, including the evolution of the team’s capabilities and deliverables as the business evolves.
KEY WORKING RELATIONSHIPS
- Internal: The role interfaces with other leadership functions in the regional business unit and within global Regulatory affairs unit, e.g., medical, quality, R&D, region SH heads, communications, procurement, legal, marketing, business divisions and strategic units etc. to provide strategic leadership & execution across the regional CHC organization
- External: KOLs, regulatory authorities, external business partners, Vendors
SKILLS, EXPERIENCE & KNOWLEDGE REQUIREMENTS
- Ph.D., M.D. Degree or equivalent experience is mandatory. Other postgraduate qualifications are desirable and supportive.
- Proficient in regional regulations, guidelines good practices pertaining to the pharmaceutical industry standard and practices for Regulatory affairs domains.
- Over 15 years' experience in medical and R&D functions and/or other Regulatory field experience in consumer healthcare/pharmaceutical industry environment is required
- Significant team and resource management experience in a matrix organization is required.
- Proven track record with leadership skills in people management, managing change, problem-solving, priority setting, developing teams and stakeholder management. Ability to have strong impact on the teams and functions.
- Strong social and cross-cultural skills, with a demonstrated commitment to diversity, equity and inclusion
- Significant depth and breadth of experience in Regulatory affairs, to be able to lead regional strategy range of product types from cosmetics, food supplements and drugs
- Proficient knowledge of Regulatory /therapeutic CHC area and medical terminology with ability to translate into consumer relevant terms to grow brands
- Substantial Project management experience to ensure execution with excellence in Regulatory affairs activities
- Significant experience in resource planning and management in a complex, matrix environment.
- Excellent ability to simplify communication of complex Regulatory clinical and issues and analysis orally and in writing.
- Excellent networking and influencing skills
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.