Regulatory Affairs Support Co-ordinator

Galway

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.

 

The Opportunity:

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 provide regulatory support to very busy regulatory affairs departments for the Chanelle Group Companies.

KEY RESPONSIBILITIES:

  • The functions of the Regulatory Affairs Support Co-ordinator include but are not limited to the following:

    • Requesting and coordinating the delivery of any samples, documents, fees required for regulatory applications.
    • Communicating on a regular basis with the supervisor/ relevant managers to give regular feedback on regulatory status of export applications
    • Preparation of administrative sections of Regulatory
    • Maintenance of Regulatory filing systems, indexes and
    • Assist supervisors/ managers in preparing and maintaining the department
    • Preparation and maintenance of SPC and Labelling system for regulatory
    • Organising translations for international regulatory
    • Ordering literature references and maintaining the reference files and
    • Preparation / request of documents (CPP’s, Power of Attorney and legalization of same) for the Regulatory application/ MA transfers
    • Organising translations for Regulatory
    • Forward any incoming reports (whether it is through post, e-mail or in person) regarding Pharmacovigilance / Adverse Action Report to the relevant QPPV in a timely
    • Communicating with Pharmacovigilance in line with the in-house pharmacovigilance procedures and practices for all export applications and export MA’s.
    • Typing of regulatory reports and letters and maintaining office stationery, sorting post, organizing couriers etc. on behalf of regulatory
    • Maintaining and monitoring spends v’s the department
    • Perform general invoicing duties and provide support within the department using the Softco accounts
    •  

COMPETENCIES:

    • Organisational skills, personal efficiency, time management skills and the ability to prioritise competing demands are key communication
    • Ability to manage diverse personalities and
    • Ability to build relationships and collaborate with others is
    • 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 Professional

    expertise.

    • Demonstrated ability in prioritising key initiatives, driving growth and setting targets and KPls to monitor the
    • Positive and proactive person who is energised by having great
    • Practical, action-orientated approach to managing
    • The above is not intended to be construed as an exhaustive list of all responsibilities, duties and skills
    • Strong computer skills in MS Office
  • QUALIFICATIONS:

    • Degree qualified (preferable but not essential)
    • Multinational experience (preferable but not essential)
    • 2 years+ experience in an administrative role, pharmaceutical/healthcare experience would be an
    • Excellent written and communication
    • Experience working within a pharmaceutical cGLP Environment; with knowledge of EU GMP and US FDA Guidelines

     

    PHYSICAL DEMANDS:

  • Working with computers, paper files – office work environment 

    WORK ENVIRONMENT:

    Office

Regulatory Affairs Support Co-ordinator

Galway