AMET Science Hub strategic projects & Pricing lead
Mission & Tasks
- Champion and lead the Pricing project across AMET zone.
- Champion and deliver the Zone Strategic projects (innovation, SWITCHES, geo-expansion, sustainability projects) as a growth lever for the region.
- Support the Zone and Country Science Hub Heads to build the strategic direction of the regulatory environment, shaping strategy focusing on quick wins and long terms priorities in alignment with the Zone strategy.
- Set plan for external engagement from Science perspective in collaboration with the PA teams enabling our role in reshaping the environment.
- Handle all related topics for Regulatory excellence across zone and manage all governance activities.
- They will own, deliver the risk management plans for all Science Hub Functions capturing the business impact and ensuring clear risk mitigation plans are in place. They will also ensure that risks are mitigated in line with expectations
- Foster an environment/culture of learning and sharing of best practice within the team.
- Provide CMC support for local product dossiers where needed and motivate for relevant budget to manage such activities with local vendor
Key Contributions & Activities
Pricing Environment shaping
- Alignment with the Zone and Country Science Hub Heads for the pricing strategy.
- Explore and help implement best practices – partnerships across the region, to enhance and optimize the GM and products profitability.
- Consolidation and creating a reference dashboard for the country pricing exercises across the region.
External Engagement mapping and planning
- Identify our key external stakeholders and plan scheduled activities, partnerships and collaborations.
Regulatory Excellence & Intelligence
- Set governance WoW for regulatory environment and manage all the needed activities through
- Monitoring Regulatory Changes: This involves tracking changes in laws, regulations, standards, and policies at local, national, and international levels. This can include new legislation, amendments, enforcement actions, and updates from regulatory bodies (such as the FDA, EMA, or EPA).
- Analysis of Impact of the regulatory information and its impact on the business. This involves understanding how new regulations might affect operations, compliance requirements, product development, and market access.
- Risk Management for the expected changes and outcomes.
Sustainability
- Co-ordinating with innovation/quality/IA teams to explore packaging, dosage, format innovations for sustainability (e-labelling project implementation according to regulatory agenda and ensure delivery in key strategic markets)
- Explore and help implement best practices – optimize energy consumption, minimize environmental impact, minimize emissions and exposure to chemical substances in the products by use of more natural safe ingredients.
- Be the change agent for the zone to support the global task force to achieve B Corp certification.
Product Pipeline Management (Switches)
- Drive the strategy and support regional Switch strategy for different markets as per business needs.
- Deliver and drive the OTC status roadmap
- Organize switch workshops to enhance understanding of internal stake holders.
- Collaborate with cross-functional local, regional and global teams to speedup switch projects in the zone
New product development and Innovation support
- Support key insight generation projects to identify local need gaps to drive NPD decisions.
- Collaborate with innovation teams to provide science leadership to NPDs and accelerate new launches.
- Guide and drive best-in-class prelaunch, launch and postlaunch activities.
- Complete necessary regulatory assessments for Zone high priority innovation projects.
Risk Management
- Mitigate risks for CHC portfolio from future regulatory queries and risks.
- Work closely on the risks associated with Quality and PV.
- Ensuring all risks are captured and tracked for business impact to ensure mitigations plans and closure.
- Lead and support crisis management projects for vulnerable products in the portfolio.
- Prepare crisis preparedness taskforce within Zone to act during crisis and prepare back up plans to protect the MA for the priority brands
Scope of Responsibility
Management Responsibilities:
This position is expected to move within the scope of the AMET Science Hub as part of the carve-in of CHC as a stand-alone organization. The role holder will work in close collaboration with colleagues from these respective functions and may be as well in charge of other activities within the scope of the Science Hub.
Latitude of Action:
The role holder is required to work autonomously and to take decisions in line with CHC Global Regulatory Policy, Standards and Processes.
Role Impact:
key role in ensuring the consistency in the regulatory activities and availability of the products on the market.
Scope:
It works directly with CHC Affiliate Scientific/Medical Affairs, Regulatory Affairs, Pharmacovigilance, Supply Chain as well as with colleagues from other Quality operational units as required
Reporting Line
Direct: AMET Science Hub Head
Required skills and Experience
Education: Bachelor of Pharmaceutical Sciences or other Medical Degree
Related Experience: Total Experience of minimum 7 years experience
Skill: Computer Skills, Negotiation & Communication Skills. Good planning and organization skills - Good Command of English Language.
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