US/EU Regulatory Affairs Executive

Hybrid

This is an opportunity to be part of a dynamic team within the Vet Regulatory Affairs function. We are looking for individuals who will support and drive Chanelle Pharma’s vision to be the most valued global provider of high quality, competitively priced pharmaceutical products and to provide excellent services and support to our customers.

In this role you will report into the US/EU Registration Manager

To support the Veterinary Regulatory affairs team and to achieve new marketing authorisations and maintain existing Marketing Authorisations in an efficient manner in line with company strategy.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Functions include but are not limited to the following:
  • Design product-specific regulatory programmes on allocated products and agree priorities and time schedules in conjunction with the management team
  • Manage the development of regulatory dossiers for new spot-on products for worldwide markets
  • Organize the submission and approval of new products via national, mutual recognition, decentralized and centralized procedures
  • Provide technical support to the Realoch production and Chanelle R&D teams in relation to spot-on products
  • Provide advice to R&D in relation to regulatory requirements for veterinary products
  • Communicate with colleagues in joint ventures companies
  • Liaise with regulatory bodies within Europe and with appointed agents in other countries
  • Negotiate win/win situations with regulatory bodies on issues arising during MA assessment and post MA approval maintenance procedures
  • Keep up to date with changes in global regulatory requirements
  • Provide technical support to in-house sales team, sales representatives, customers
  • Manage the review and approval of change control requests with a view to their impact on regulatory compliance and product stability and follow up on any consequential regulatory and/or stability actions.
  • Support the registration and searches for Patents and Trademarks for Chanelle products
  • Manage, Compile and submit marketing authorisation applications for products as required
  • Support the US/EU Registration Manager with MA procedures as required
  • Support the submission, approval and maintenance of new products for the US market via US FDA or EPA in conjunction with US
  • Prepare reports as required on your area of responsibility
  • Support the Veterinary Pharmacovigilance team with pharmacovigilance work ad hoc as required
  • Support the maintenance of Chanelle’s existing veterinary marketing authorisation worldwide ad hoc as required

Competencies:

  • Organizational skills, personal efficiency, time management skills and the ability to prioritize competing demands are key communication skills.
  • Ability to manage diverse personalities and viewpoints.
  • Ability to build relationships and collaborate with others is vital.
  • Strategic decision-making within the business as an influencer.
  • Being able to understand company finances, resourcing and ultimate aims of the business is important role-modelling.
  • Demonstrate and lead on the values, initiatives and culture of an organisation. Professional expertise.
  • A strong working knowledge of best practice processes, change management implementation, coaching and mentoring.
  • Demonstrated ability in prioritising key initiatives, driving growth and setting targets and KPIs to monitor the performance
  • Positive and proactive person who is energised by having great responsibility
  • Practical, action-orientated approach to managing priorities and teams.
  • The above is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required.
  • Strong computer skills in MS Office

     

    The above is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required.

Qualifications:

• Scientific qualification and background preferably B.Sc. or equivalent.

• Minimum 3 years in an FDA or EU regulatory/R&D environment preferably with experience of generic applications. Knowledge of EU regulatory submissions would be an advantage.

• Knowledge of gmp quality requirements for EU veterinary products

• Experience in busy problem-solving environment with the ability to work to tight deadlines and on one’s own initiative.

• Detailed technical knowledge of products and processes.

• Strong Customer Service focus both internally and externally

• Good command of technical English (both written and spoken)

• Ability to work on multiple projects simultaneously.

• Communication skills with external and internal customers.

US/EU Regulatory Affairs executive

Reference No: J0724
Hybrid