Head of Veterinary Regulatory Affairs
About Chanelle Pharma:
Chanelle Pharma is Ireland’s largest indigenous generic pharmaceutical manufacturer of both medical and veterinary products.
Serving customers in 96 countries worldwide, Chanelle Pharma is a partner of choice in the development and manufacturing of pharmaceutical products to the world’s leading human generic and animal health multinationals and distributors. We are passionate about understanding and addressing the challenges facing our medical and veterinary customers and bringing them innovative and effective products and solutions.
Building on over 35 years of research and development, with over 4,500 licenses registered worldwide, Chanelle Pharma is headquartered on an 18-acre campus in Loughrea, Co Galway, with three manufacturing facilities, four research and development laboratories and a fifth R&D laboratory in Jordan. The company employs 550 people in Ireland, UK, Jordan and India. At Chanelle Pharma our employees drive our success and you will have the opportunity to collaborate in our diverse and inclusive environment, the ability to learn and grow in your career, and an opportunity to make a direct impact on our business and customers.
Chanelle Pharma has a proven track record of innovation and makes a significant investment in R&D annually and has doubled its sales growth in the last 5 years.
In 2018, the company announced an €85 million investment, the single largest investment by any Irish owned company, to double manufacturing capacity, launch 96 new products and grow its workforce to 850 people over a period of 5 years. As part of the investment, Chanelle opened a purpose built €10 million manufacturing facility in 2018 for the company’s expansion plans into the US market. The facility received FDA approval in September 2019.
Chanelle Pharma is on an ambitious growth trajectory and expanding its workforce across a number of disciplines in science, engineering, quality, finance, sales and marketing. The company won 2018 Pharma Company of the Year and Industry Company of Year, the first indigenous Irish company to win the award.
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 MD.
To Manage 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.
The functions of the Head of Veterinary Regulatory Affairs include but are not limited to the following:-
§ Maintain Existing Marketing Authorisations World-Wide
- Design product-specific regulatory programmes and agree priorities and time schedules in conjunction with the management team
- Organise and lead the submission and approval of new products via national, mutual recognition, decentralised and centralised procedures
- Manage the maintenance of all Chanelle’s existing veterinary marketing authorisation worldwide
- Contribute to the development of the Chanelle Group by active participation at Management level
- Organise and co-ordinate appropriate resources to meet the demands of the Regulatory Programme as agreed with Managing Director/senior management team
- Manage Chanelle’s Veterinary Regulatory affairs team and provide advice to R&D in relation to regulatory requirements for veterinary products
- Manage all elements of external studies including:-
- Identification and Out-sourcing of Animal Studies to Good Laboratory Practice (GLP)
- Identification and Out-sourcing of Animal Studies to Good Clinical Practice (GCP) approved sites
- Protocol design for Clinical / Bioequivalence / Tolerance studies
- Communication with study directors responsible for out-sourced trial work
- Liaise with regulatory bodies within Europe and with appointed agents in other countries
- Negotiate win/win situations with regulatory bodies on issues that arise during assessment.
- Communicate with colleagues in joint ventures companies
- Review regulatory issues in Contracts, Secrecy Agreements and Sales and Distribution Agreements
- Keep up to date with changes in global regulatory requirements
- Provide technical support to in-house sales team, sales representatives customers
- Co-ordinate the registration and searches for Patents and Trademarks for Chanelle products
- Identify training needs within the department and implement appropriate training plan.
- Review and approve 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.
- Organisational skills, personal efficiency, time management skills and the ability to prioritise competing demands are key communication skills.
- Ability to lead a team and 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.
- Proven people management capabilities. Ability to motivate a team and collaborate cross-functional and across geographies
- 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.
- Scientific qualification and background preferably B.Sc. or equivalent.
- Minimum 10 years in a FDA/CVM regulatory/R&D environment preferably with experience of generic applications. Knowledge of EU regulatory submissions would be an advantage.
- 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.