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  • Posted: Dec 17, 2024
    Deadline: Not specified
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  • Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At the same time, the Group aims to create value through innovation, growth and high earning power. Our products are helping to address some of today&rsqu...
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    Consumer Health: Regulatory Affairs Lead

    Key responsibilities and tasks:

    • VACC leader/Business Leader for the regulatory team in South East Africa. 
    • Coach & develop the Regulatory function of SAE to ensure consumer centricity, innovation and regulatory excellence & governance. 
    • Member of the local SEA Management Team & the CH METAP Regulatory Leadership Team. 
    • Provide management support to the sub-regional regulatory and business leadership to business initiatives in view of the complex & changing regulatory environment and the business expansion plans for the sub-region. 
    • Drive and actively support the implementation of the regulatory strategy tailored to the special needs of the sub-region 
    • Drive the regulatory processes and activities in alliance with the overall regional strategy of the portfolio in SEA including new and existing marketing authorizations of products in all categories (medicinal, cosmetics, MDs and food supplements).
    • Actively supports the organization with product related issues and risk management activities, by providing regulatory advice to internal partners including Medical, Marketing, Quality, Business Development, regional and global Regulatory Affairs and other RMSQC function in order to contribute to development and marketing processes, incl. licensing-in activities 
    • Review the external regulatory environment and share intelligence with relevant internal parties, understanding and communicating the Key Tasks: impact of the information in relation to the CH business 
    • Represents Bayer as a competent reliable partner to the local Health Authorities & responsible for an excellent company image and to the company success by building and maintaining professional relationship with the Health Authorities. 
    • Serves as BCH representative in trade associations in all regulatory matters, and building regulatory networking with national regulators, local subregional industry organizations and key opinion leaders.

    Key Working Relations:

    • Local, Cluster, Regional & Global Regulatory, Medical, and RMSQC/R&D team 
    • Country Commercial Lead and respective management team 
    • Local Marketing, Medical, Drug Safety & Quality  
    • External: health authority & trade associations

    Experience, Skills and Qualifications

    • Education: University degree in pharmacy 
    • Proven track record in Consumer Health Regulatory Affairs or related positions at least for 7-10 years with extensive experience in leading major projects
    • Demonstrated ability to work in a regulatory capacity supporting business objectives while ensuring appropriate governance.
    • In-depth understanding of National and Africa regulatory requirements and experience in managing national registration procedures
    • Customer focus & commercial awareness. Team spirit and people management skills. 
    • Ability to communicate effectively and assertively with sound negotiation skills. 
    • Ability to communicate complex information to all levels.
    • Fluent in English. 
    • Flexibility in frequent travel

    go to method of application »

    Africa Regulatory Science Hub Lead

    Key Task and Responsibilities:

    • Work with the team to set a vision for regulatory affairs for CP, BLX, PCM, Seed, Traits, Digital Solutions and Stewardship objectives in AFR, and guide but empower teams to define and deliver specific pipeline registration, product registration, and renewal/defense/LTO and STW outcomes, in support of customer-enablement goals at country level.
    • Architect internal and cross-functional workflows in collaboration with stakeholders. Take initatives to create/populate/evolve/sunset product/technical teams, both for the AFR RS hub, as well as for its working interfaces with other teams such as the EMEA RA hub and other Country RS hubs in EMEA, the global Safety and RA/RSA/RM centers, and crossfunctional interfaces with the customer-enabling support squad(s) in AFR, a.o. 
    • Catalyze break-throughs in case of obstacles
    • People Management of the diverse talent profiles in the AFR RS hub, including identifying talent needs, attracting talent to replenish or evolve the talent pool, and fostering development opportunities. Create an environment where effecitve peer-feedback is welcomed, provide coaching to teams and individuals, and fulfill administrative requirements wrt HR processes/performance management 
    • Act as a responsible steward of the AFR RS hub resources and support flexible resource allocation to achieve prioritized R&D and Business objectives, as guided by Product and Technical Teams that have been granted applicable pipeline/portfolio decision rights.
    • Identify resource bottlenecks and interface with the team, stakeholders and other leaders to find optimal solutions that remove roadblocks, create agile and productive solutions, and maximize value-creation for the customer and enterprise
    • Safeguard Diversity, Equity and Inclusion, and ensure workload and development opportunities are distributed in fair and equitable manner, in order to build a great place to work with an agile, engaged and fulfilled workforce 

    Qualifications and Skills:

    • Creative Mindset
    • Visionary: guide teams in defining the outcomes to deliver on the mission 
    • Architect: shape a value-creating system to unleash the passion and energy of our people
    • Catalyst: remove roadblocks to facilitate connection and collaboration
    • Coach: help teams learn and build the capabilities needed to create value for customers and stakeholders
    • 5 DSO Behaviors
    • Regulatory expertise in Agricultural Technologies CP/BLX and S/T
    • Advanced academic science degree in Life Sciences, Agronomy, or related
    • Strong verbal and written communication skills in English; with knowledge of additional local languages a strong plus
    • Compliance orientation, Business acumen and Innovation mindset
    • Excellent networking with global, regional and local functions The job requires the social competencies to understand, influence and motivate through VACC leadership, combining professional backgrounds, different countries, nationalities and cultures, and languages

    Method of Application

    Use the link(s) below to apply on company website.

     

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