Regulatory Affairs Officer

03/11/2023

תיאור

לחברה גלובאלית העוסקת בפיתוח, ייצור ושיווק בתחום הפארמה דרוש/ה Regulatory Affairs Officer

:Responsibilities

 Provide regulatory support for the company’s veterinary vaccine portfolio

 Support all regulatory aspects of assigned projects in accordance with the business strategy, priorities and timelines

 Establish and maintain effective working relationships with other PAHC business units (Manufacturing, Quality and Marketing) to ensure regulatory perspectives are incorporated into business plans

 Establish and maintain effective working relationships with other Phibro regulatory affairs team members

 Provide regulatory guidance in relation to new product development when needed (including review of study protocols and reports). Draft requests for scientific advice

 Review and critique documentation intended for regulatory submissions to ensure relevant regulatory requirements are met

 Compile and draft registration dossiers suitable for global markets (domestic and export)

 Support submissions in target countries and when needed, lead regulatory activities in specific markets to obtain and maintain licenses

 Support all types of product lifecycle activities (draft and compile renewals, variations, post authorisation commitments etc.)

 Draft responses to questions raised by regulatory authorities

 Support needs of other business units e.g. Operations (management of change control, preparation for inspections) and Marketing (review of marketing brochures)

:Reporting line

.The successful candidate will report to the regional Regulatory Affairs Manager

דרישות התפקיד

:Key requirements

 Detailed knowledge and understanding of the EU Veterinary Medicines regulatory framework, European Pharmacopoeia and guidelines

 Strong technical expertise in product quality/safety/efficacy (able to understand, critique and present information in a format appropriate to the audience)

:Education & Experience

.Minimum of a Bachelor’s degree in a relevant scientific or veterinary discipline, but higher degree preferred

.Ideally at least three years of industry experience, including experience in regulatory CMC (Part 2 – Quality)

.Proficient in written and spoken English. Additional language skills are a plus

.Experience with veterinary vaccines is preferred, but candidates with experience of veterinary pharmaceuticals may also be considered

:Personal attributes

.Self-starter, takes initiative

.Team player essential – the work will involve close collaboration with RA colleagues and other business units

.Ability to handle several projects simultaneously

.Good organizational, prioritization and time management skills. Can work effectively under pressure

.Excellent attention to detail

.Proactive: identify regulatory risks and propose solutions

.Demonstrate integrity