Vet Regulatory Affairs Executive
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 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 assist in the process of development of new products, attaining and maintaining Product Licences / Marketing Authorisation for the Chanelle Group Companies
The functions of the Veterinary Regulatory Affairs Executive include but are not limited to the following:
- Compilation of VICH regulatory dossiers Parts I-IV for EU National, MRP, DCP and centralized Marketing Authorization (MA) Applications
- Preparation and submission of renewal applications for existing MA’s
- Preparation and submission of variation applications for existing MA’s
- Review of process validations protocols and reports for inclusion in Part II
- Review of method validation data and stability to be included in Part II
- Review of Drug Master Files
- Review of protocols for bioequivalence, residue and efficacy studies and reports
- Writing of Expert Reports for European MA’s
- Responding to queries raised by the regulatory authorities
- Artwork review and approval
- Transfer of data from Regulatory Dept. to QA, QC, Production
- Responding to customer queries and queries from other departments
- Timely and accurate preparation of dossiers for submission and response to authority questions
- Attention to detail in generation of dossier, protocols and reports
- Ability to work on multiple projects simultaneously
- Communication skills with external and internal customers
- Organisational skills, personal efficiency, time management skills and the ability to prioritize 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
- 3rd level qualification
- Degree qualified (preferable but not essential)
- Multinational experience (preferable but not essential)
- 5 years + experience in a similar role, pharmaceutical/healthcare experience would be an advantage.
- Excellent written and communication skills.
- Experience working within a pharmaceutical cGLP Environment; with knowledge of EU GMP and US FDA Guidelines