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Agricultural commodities / active substances / DG SANTE, EFSA
Switzerland
Perm
20088
Perm
Switzerland
An EAME Regulatory Manager who has EU Agriculture Or active substances & EU Regulatory Processes experience and holds MSc or PhD in Science Subject or Similar in Education. REMOTE working role with Basel HQ – this role can be Based in ANY: EU Location / Switzerland Or UK you choose!
You will lead Regulatory Project Team for Regulatory: advisory, strategies, advice , foresight, insights into competitor portfolios, regulatory support to non-EU teams to Senior Management / Senior Stakeholders. In summary you will Serve as centre of expertise within EAME regulatory for any assigned focus role.
You MUST Have
o MSc or PhD in Science Subject or Similar
o EU Agriculture / EU Regulatory Processes.
o Strong EU regulatory Knowledge
o Fluent English Language – Other EU language advantage
This role needs a Regulatory SME with experience working with Chemistry / Agricultural commodities / active substances. Regulations working with bodies such has: DG SANTE, EFSA
HQ in Basel – Or could be remote depending on experience, including alternative legal entities such as UK or elsewhere in the EU.
Responsibilities
• Develop and implement robust regulatory strategies to support the portfolio of assigned active substances and products in EAME
• Defend and advocate strategy in relation to the assigned portfolio opposite regulatory bodies
• Provide high quality regulatory advice and foresight to wider EAME Regulatory community and key stakeholders (e.g. business, development, global) to support the development of the EAME portfolio strategy
• Obtain and maintain EU approval of active substances in line with agreed portfolio objectives through
o Leadership of the EAME Regulatory Project Team
o Effective management of relations and communication with Rapporteur Member States, DG SANTE, EFSA and wider EAME Regulatory team
o Effective partnership with relevant internal project teams to facilitate business decisions and represent regulatory and product safety position
• In partnership with the EAME Regulatory Processes and Submission Management team and wider EAME Regulatory, obtain and maintain EU Member State product authorizations in line with agreed business objectives through
o Effective partnership with relevant project teams to represent regulatory and product safety positions and facilitate business decisions
o Effective management of relations and communication with Member State regulatory authorities and wider EAME Regulatory team
• Provide regulatory support to non-EU teams within the EAME region and beyond to enable and support authorizations as well as global trade of agricultural commodities treated with company products.
Skills needed
o Degree in Science and preferably post-graduate qualification (MSc or PhD)
o Solid understanding of regulatory processes in the EU
o Good understanding of agriculture in the EU
o Proven ability to manage complex issues considering delivery timelines, cost and risks
o agricultural commodities/ active substances experience
o Collaboration across functional and geographic boundaries with excellent interpersonal skills
Send your profile now for review.