Regulatory Affairs Manager
Hours: Part Time
Placed on: 14 February 2023
Closes: 14 March 2023
5-10 years relevant experience
Applicants must have the right to work in the UK
Bionema is recruiting for a Regulatory Affairs Manager to join a highly successful biological technology developer company with a strong portfolio of marketed and developmental products. This is an exciting time for the Bionema as they move to later phase development and marketing authorisation across Europe, NA, CA, AU, India.
Bionema is an award-winning and leading biopesticide technology manufacturer and developer to protect crops from pest and disease, reducing the use of synthetic pesticides, enhancing food security and increasing crop yields in agriculture, horticulture, forestry and turf and amenity sectors. The company focuses to develop and bring innovative formulations, effective and profitable biopesticide technology to meet current and future market demands. Bionema supplies specialist bio-control products to the horticulture, sports turf and forestry sectors, providing training aimed at increasing the product efficacy.
We are looking for an experienced Regulatory Affairs Advisor to undertake responsibility for the Plant Protection Products (PPPs) registration in EU, USA, associated safety documentation in the form of Safety Data Sheets (SDS), product labelling, technical leaflet, packaging and manufacturing. Knowledge of CLP, REACH and the requirements for SDS in Europe is essential for this position with experience using SDS authoring software. A Dangerous Goods Safety Advisor qualification would be deemed advantageous. As the Regulatory Affairs Advisor you will be responsible for providing regulatory guidance on the design, development and commercialisation of the products. You will manage regulatory submissions and updates to ensure all licensing and registration requirements are met.
Duties of Regulatory Affairs Manager will be varied however the key duties and responsibilities are as follows:
- Establish regulatory strategies for new products and manage regulatory submissions of biopesticides, biostimulants and biofertilizers in agriculture.
- Regulatory compliance of products and associated safety documentation in the form of Safety Data Sheets (SDS), product labelling and packaging.
- Work Closely with the Regulatory Authorities, internal and external customers, suppliers and laboratories to ensure information is compliant for audits and inspections.
- Create and maintain formulation and finished goods safety data sheets in multiple languages.
- Communicate relevant information to allow NPD teams to ensure compliance in sales region by incorporating all necessary attributes into product design.
- Remain up to date with all relevant legislation in countries affecting products including but not limited to; Reg. (EC) No 1107/2009, REACH, GHS, CLP, UN Transport, Biocidal Products, Aerosols, VOC and Detergents regulations.
- Conduct regular assessments of the regulatory landscape and identify likely changes to establish potential business impact, then communicate this effectively across relevant business functions.
- Continuously review and seek to improve information creation and flow, systems & processes to ensure efficient servicing of internal and external customer requirements.
- Communicate with suppliers to ensure relevant regulatory information is made available.
- Relevant degree in a science subject (eg. Chemistry, Biochemistry, Bioengineering, Biology) alongside Industry experience in Regulatory Affairs.
- Proven industry experience in Regulatory filing processes for Plant Protection Products (PPPs) in the EU and USA market.
- A working knowledge and practical experience with managing people, the manufacturing processes and biological products awareness in the USA and EU markets.
- A Dangerous Goods Safety Advisor qualification would be deemed advantageous.
Key words: Biopesticides, Product documentation, Regulatory Affairs, Reg. (EC) No 1107/2009, CLP, SDS, SAP, Product labelling, Packaging, DGSA, Regulatory authorities, Licencing, Submission.
What we offer
- Excellent holiday and pension package.
- Excellent continual professional development opportunities, both internal and external, as a part of our training commitment.
- Bionema is committed to the principle of equal opportunity in employment.
- Excellent location and working environment.
Normal hours of work are 37.5 hours per week. A flexible approach to work is needed as there will be a requirement to work overtime (evenings and weekends) during busy periods.
How to apply
To apply for this position, please send your CV, completed Application Form and Covering Letter, and identifying how you meet the job criteria to email@example.com no later than Friday at 12:00 each week for review.
Informal enquiries should be emailed to firstname.lastname@example.org.
Candidates not demonstrating their ability to meet the essential criteria will not be assessed for interview. https://bionema.com/