Role purpose
Regulatory ownership of assigned active substances and/or formulated products to ensure delivery of the portfolio objectives in line with agreed business strategies and budget.
**This role can be based within the EU**
Job responsibilities:
1. Obtain and maintain EU approval of active substances in line with agreed portfolio objectives through:
- Perform and/or coordinate detailed Data Gap Analysis and Preliminary Risk Assessment, based on available information from the company or external parties
- Effective coordination of work programmes with consultants and contract research organisation. Responsible for placing and monitoring the relevant studies in external laboratories. Accountable for dossier preparation including risk assessment in collaboration with consultants. Responsible for project budget building and tracking.
- Effective management of relations and communication with (Rapporteur) Member States, DG SANTE, EFSA, HSE and internal EU Regulatory team
- Effective partnership with relevant internal teams (R&D and Marketing) to facilitate business decisions and represent regulatory position.
- Ensure regulatory databases are effectively used and regularly updated.
2. Obtain and maintain Member State product authorizations for products in Europe in line with agreed business objectives through:
- Responsible for the evaluation of the registrability in the EU and GB of new and existing products. Evaluate the cost needed to obtain/maintain the registration.
- Effective partnership with relevant teams (R&D and Marketing) to represent regulatory position and facilitate business decisions.
- Effective coordination of work programmes with consultants and contract research organisation. Responsible for placing and monitoring the relevant studies in external laboratories. Accountable for dossier preparation including risk assessment in collaboration with consultants. Responsible for project budget building and tracking.
- Effective management of relations and communication with Member State regulatory authorities and internal Regulatory team.
- Ensure regulatory databases are effectively used and regularly updated.
3. For assigned non-AS responsibilities (focus roles):
- Source of expertise within EU regulatory for any assigned focus role and share current understanding and potential developments to the wider regulatory community.
- Provide high quality inputs to Crop Life Europe team (if applicable) in line with agreed UPL objectives
4. Follow updates of regulations and guidance documents.
5. Support and lead, where applicable, advocacy actions.
Knowledge, experience & capabilities:
Critical knowledge
- Scientific background in the disciplines relevant for regulatory, ideally in the field of toxicology
- Good understanding of regulatory processes in the EU and GB
- Good understanding of the scientific guidance documents
Critical experience
- Regulatory experience in the EU (at least 10 years) in managing dossiers (active ingredients and products), conducting risk assessments and monitoring studies
- Negotiation and advocacy skills
Critical technical, professional and personal capabilities
- Effective time and task management to ensure delivery of the business needs.
- Perform tasks in an accurate, timely and efficient manner.
- Excellent organisational skills with the ability in being autonomous.
- Stimulated by new challenges and by solving complex scientific questions, that mobilizes skills of foresight, innovative ideas.
- Proactively seek to add value to processes, both existing and new.
- Effective team worker.
- Openness and willingness to challenge the accepted ways of working and implement new ones.
- Good communicator, clear presenter, problem solver.
- Performance driven, with a “can do” attitude.
Notice to Recruiters and Staffing Agencies:
UPL and its affiliates and subsidiaries (“UPL”) have an internal recruiting department. UPL may supplement that internal capability from time to time with assistance from temporary staffing agencies, placement services, and professional recruiters (“Agency”). Agencies should only contact UPL’s Human resources department (hereafter referred to as HR department) for staffing requirements at UPL which would present all candidates internally. Agency must obtain written approval from UPL’s HR department before submitting resumes, and then only in conjunction with a valid fully executed contract for service and in response to a specific job opening will UPL pay the agreed upon service fees. UPL will not pay a fee to any Agency that does not have such agreement in place.
Diversity&Inclusion at UPL:
UPL is an equal opportunity employer and all qualified applicants will receive equal consideration for employment without regard to race, color, religion, gender, sexual orientation or preference, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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