LS
Senior Regulatory Affairs Specialist
Contract type
Ongoing
Work mode
Remote · EU
Experience
Senior · 6+ years
Job description
Senior regulatory affairs role owning EU registration and renewal outcomes for a portfolio of plant protection products across multiple Member States. The position is hands-on, authoring and defending dossiers and dRRs while directing consultants and advising Commercial on regulatory impact.
At a glance
- Work mode
- Remote · EU
- Languages
- English – C2
What you'll do
- Owning registration and renewal outcomes for a portfolio of plant protection products across a number of EU Member States
- Developing and executing strategies for new registrations, renewals, amendments and complex or non-standard submissions under Regulation (EC) No 1107/2009
- Building strong, long-term relationships with national competent authorities across the Northern, Central and Southern zones
- Owning responses to regulatory queries, coordinating internal experts and external partners to answer them thoroughly and on time
- Personally authoring and reviewing regulatory dossiers, including draft Registration Reports (dRRs) covering efficacy, physical-chemical properties, toxicology, residues, environmental fate and ecotoxicology
- Building clear, concise scientific and regulatory arguments, and defending them with authorities
- Directing and quality-checking the work of consultants, CROs, task forces and test facilities: setting the strategy and owning the science, not outsourcing the thinking
- Making sure every submission is scientifically robust, strategically positioned and consistently high quality
- Managing lifecycle activity, including renewals, label amendments, MRL setting and post-approval commitments
- Staying ahead of changing EU and Member State requirements, guidance documents, AIR renewal programmes and review timelines
- Building forward-looking intelligence on key active substances and upcoming reviews, and using it to shape portfolio and commercial strategy early
- Partnering with Commercial and Portfolio teams to align regulatory direction with business goals and market opportunity
- Turning regulatory complexity into clear, actionable business insight, including guidance on launch timing, readiness and risk
- Managing project costs and timelines, delivering on time and within budget, and reporting clearly on progress
- Representing Regulatory Affairs in new product introduction and cross-functional forums
- Building strong working partnerships inside the business and with authorities, consultants, CROs, task forces and test facilities
- Growing a network across the European agrochemical and regulatory landscape
What we're looking for
- Six or more years registering plant protection products in the EU
- Hands-on experience preparing and authoring dossiers and dRRs yourself
- Deep knowledge of Regulation (EC) No 1107/2009, the zonal evaluation system and related guidance
- Regulatory experience across a number of EU Member States, and an understanding of their national specificities
- A relevant scientific degree (e.g. chemistry, biology, toxicology, agronomy or a related discipline)
- A commercial mindset: the ability to connect regulatory decisions to business outcomes
- Strong project management skills, and the ability to juggle shifting priorities without losing sight of the detail
- English to a very high standard, written and spoken (C2 on the CEFR), and the confidence to liaise with authorities and senior stakeholders
- Someone who builds trust easily, influences without authority, and is comfortable working where guidance is still evolving
- Proficiency in Microsoft Word, Excel and PowerPoint
Nice to have
- An MSc in life sciences, chemistry or a related field is preferred
Your team
R&D / Regulatory Affairs
Laboratory and regulatory scientists working together as one integrated team with a single goal: registering products in the shortest possible timeframes.
Apply
About Life Scientific
Reverse-engineers off-patent crop protection products with scientific rigour and brings them back to market with precision and speed. Backed by InVivo, Europe's largest agricultural co-operative, and scaling across Europe and North America.
Key facts
- Dublin, Ireland
- Crop protection
- Operates in a $250 billion global crop protection market
- Backed by InVivo, Europe's largest agricultural co-operative
- Scaling fast across Europe and North America
- Combines the pace of a start-up with the discipline of a scale-up
Partners & customers
InVivo
What they value
- No politics
- No passengers
- Diverse and inclusive teams