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Ref: RAECCC

Regulatory Affairs Executive (Life Sciences)

  • Dublin
  • Negotiable
  • Permanent full-time
  • Updated 20/03/2017
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Description

Regulatory Affairs Executive

 

 

Do you want to be part of a team that’s focused on developing novel agrochemical products that will make a real difference to agriculture globally?

Do you have experience in regulatory affairs within the life sciences?

 

Specialising in the development and registration of crop protection products, Life Scientific Ltd is located on the UCD campus at NovaUCD, the innovation hub of Ireland’s largest University. Together with our partner InVivo (www.invivo-group.com), France’s largest co-op (€6billion global sales; 8,800 employees worldwide), we are expanding our R&D pipeline to support our global growth.

Our goal is to be the most successful agrochemical innovator ever. Everything we do supports this goal – scientifically and commercially. Our company culture is based on shared leadership and coupling responsibility to expertise; creating a flexible, collaborative environment for a uniquely rewarding and enjoyable work experience.

Our laboratory scientists are focused on applying their expertise in organic and analytical chemistry to the company's product development pipeline. Our Regulatory Scientists understand the complex legal and regulatory protections that apply to these products, and work with the relevant authorities in major European markets, using regulatory science to secure product registrations.

Life Scientific’s competitive advantage is based on being first to market. The laboratory and regulatory teams work seamlessly together to ensure the best possible outcomes in the shortest possible timeframes. Our Supply Chain team manage a virtual, global supply chain, sourcing active ingredients from China and outsourcing manufacturing to toll manufacturing partners in Europe. Our products are quality assured by our Quality Compliance team, and sold through exclusive relationships with distributors in key chosen markets.

Core to our success is recruiting the right people who will thrive in our culture, enabling company performance to excel while also achieving their personal career goals. At Life Scientific you will be part of a high growth company with global ambition. Our products are already being sold alongside some of the biggest brand names in the industry in the largest EU agrochemicals markets, and we are working on expansion into markets outside the EU. In a world that's increasingly focused on feeding more people, more efficiently and more safely, our products will make a difference.

If you’re looking for the opportunity to use your expertise and knowledge every day to make a difference, come join us.

Due to ongoing growth of our product portfolio and entry into new markets, we have exciting opportunities in our Regulatory Affairs team for scientists who wish to put their knowledge and training to use in a fast-paced, results-focused commercial R&D environment.

The Regulatory Affairs team are responsible for obtaining and maintaining product registrations for Life Scientific products, based on exacting regulatory requirements. Currently working across EU markets, success comes in the form of achieving and retaining the authorisation of LSL products, through a variety of documentation mediums – electronic, paperwork, labels, registration submissions etc.

This role will be a fundamental part of our R&D team, and the successful candidates will be responsible for key deliverables vital to maintaining existing product authorisations and obtaining new authorisations in European and global markets.

Strong communication and organisational skills are key, as well as attention to detail and the focus to get the job done in an efficient, timely and accurate manner.

This is a technically demanding, but very rewarding, role for scientists looking to forge a career in a cutting edge crop protection company.

Main Responsibilities will include:

  • Preparation, review and approval of regulatory submissions for new product applications
  •  Maintenance of existing authorisations across a number of countries
  •  Liaise with regulatory authorities, external consultants, CROs, test facilities and other internal departments (e.g. laboratory) in support of product authorisations
  •  Work with other regulatory teams to determine approval pathways to new markets
  •  Regulatory affairs representative on cross-functional project teams
  •  Preparation and review of guidance documents
  •  Confidential management of sensitive and technical information, along with collating and communicating data to team members
  •  Escalate major issues to key individuals
  •  Any other tasks deemed appropriate by Regulatory Affairs Manager

 Attributes:

  • Excellent academic record in a life sciences discipline, e.g. BSc (minimum 2.1), preferably agrochemical/chemistry based
  •  Minimum of 2-3 years experience in regulatory affairs, ideally within an industrial setting
  •  Ability to present clear and concise written arguments to support a specific regulatory or scientific position on a topic
  •  Perform tasks in an accurate, timely and efficient manner
  •  Excellent attention to detail is a must
  •  Ability to work on own initiative or as part of a team, in meeting strict timelines
  •  Excellent organisational skills with the ability to multi-task and work in an environment with shifting priorities
  •  Proactively seek to add value to processes, both existing and new
  •  Performance driven, with a 'can-do' attitude
  •  Proficiency in Microsoft Word, Excel, PowerPoint.
  •  Proficiency in an EU language (French/German/Spanish/Italian) would be an advantage 


Life Scientific Ltd

Life Scientific Ltd

 

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