NGO JOBS

Organization: NRS International
Country: United Arab Emirates
Closing date: 26 Oct 2013

Our Company’s Head office in Dubai is seeking to welcome Regulatory Affairs Officer to support product licenses/registration in a country or group from initial submission/approval and through the product life cycle. We are a leader in manufacturing and supplying core relief items in the humanitarian aid sector.

Job Description:

• Preparation of dossiers and technical files for tenders and responsible for product registration in different countries.
• Ensuring that a company's products comply with the regulations of the World Health Organisation Pesticide Evaluation Scheme (WHOPES);
• Keep track of the ever-changing legislation in all the regions in which the company wishes to distribute its products.
• Responsible for the presentation of registration documents to regulatory agencies, and carry out all the subsequent negotiations necessary to obtain and maintain marketing authorization for the products concerned.
• Co-ordinate with the cross functional departments for primary data documents, certificates and samples required for submission. Collate and review primary data received from different departments towards regulatory dossier compilation for the relevant markets.
• Preparing submissions of license variations and renewals to strict deadlines.
• In coordination with manufacturers to obtain all the relevant licenses and certificates for pesticide products and manufacturing licenses perform registration renewals & variations during the life cycles of products or dossiers filed in assigned markets.
• Reviews and evaluates information on applications for registration of products containing pesticides chemicals for compliance with statutory regulations: Reads registration applications from manufacturers and distributors of pesticides, fertilizers, and other products containing pesticides chemicals.
• Reviews statements concerning product ingredients, effects of misuse, and administration of antidotes for adequacy of information and conformance to regulatory requirements for substances.
• Contacts manufacturers and distributors of products not meeting standards to clarify regulations and to suggest changes in label information to permit registration.
• Obtain and defend regulatory approvals for sourced products.
• Provide input on design and reporting of studies for use in regulatory dossiers.
• Contribute to the preparation, including substantial independent writing, of regulatory applications for submission to EPA and PMRA.
• Monitor the progress of applications through regulatory review processes and draft responses to questions from regulatory agencies.
• Interact with regulatory agencies on matters related to compounds.
• Participate in the management of post-approval regulatory activities.
• Serve as primary contact and information source for registration authorities’ regulators and maintain good working rapport with regulators

Skills:

• Strong capabilities in the interpretation and communication of results from scientific studies performed to support registrations.
• Experience in conducting and defending weight of evidence evaluations.
• Ability to independently prepare succinct, scientifically accurate, and clearly written technical documents.
• Strong computer skills, including database management and use of modeling software for dietary and/or environmental risk assessment.
• Knowledge of Good Laboratory Practice (GLP) and regulatory study requirements.

Qualifications

• 5-6 plus years work experience with regulated products, through prior similar position in industry.
• BS or preferably higher degree in chemistry, biology or related field, with background in conducting scientific studies for agrochemical registration.

How to apply:

Your application must include a comprehensive resume listing your full employment history, a list of educational qualifications, including where and when completed. Please apply by email ONLY at meriem.hadjaj@nrs-international.com and write APPLICATION - REGULATORY AFFAIRS MANAGER in the subject header. No faxes/phone calls/regular mail will be considered.

Closing date: 26 October, 2013