Regulatory Affairs Manager
- Experience Level
As the Regulatory Affairs Manager for Halewood Chemicals, you’ll have a high-level of responsibility, broad-focus and have the chance to shape a growing pharmaceutical business. You’ll lead and execute the business’ regulatory strategy and plans. You’ll be responsible for all regulatory affairs related to the company’s marketing authorisations. Meanwhile, you’ll carry out management duties for the regulatory team of 3 full-time staff and contractors, helping coach and lead them. Your entrepreneurial drive and expert knowledge will drive forward the business. Working for a small, family-owned business, you will become a key voice, from day one, in deciding the strategic direction of the company.
- A relevant bachelor’s degree (master’s degree or Ph.D. degree preferred).
- Minimum of 8 years industry experience.
- Previous experience in a similar sized SME business.
- Previous experience updating technical files and design dossiers.
- Demonstrable knowledge of MHRA, EEA, ASEAN Regulations and other international regulations pertaining to the design, manufacture and commercialization of generic pharmaceutical finished products required.
- Previous experience in the development of regulatory strategies.
- Previous experience interacting with international Health Authorities.
- Previous project management / project lead experience.
- Ability to think strategically, taking in the bigger picture and setting aims and objectives to develop and improve the business.
- Proven ability to multi-task and manage multiple projects while paying attention to detail.
- Proactive, independent worker who is highly organised and interested in the difference they can make through their individual contribution.
- Responsible for all regulatory affairs related to the company’s generic finished product marketing authorisations.
- Prepare MHRA and international submissions for new product licenses and license changes, as required, to ensure timely approval for market release.
- Communicate directly with international affiliates and regulatory agency personnel.
- Provide support to currently marketed products as necessary. This includes reviewing labelling, promotional material, and other post-market activities.
- Support Product and Manufacturing changes as necessary. This requires development of regulatory strategies, creating and submitting change notifications to regulatory agencies, updating technical files and design dossiers.
- Ensure regulatory affairs files are maintained to support compliance with regulatory requirements.
- Support internal and external audits by regulatory agencies as required.
- Actively works and communicates with customers and partners.
- Lead and execute the businesses regulatory strategy and plans.
- Work with the managing director to help define company strategy, growth trajectory and investment decisions.
- Understand requirements & implications of changes within the business and the regulatory impact these will have and develop plans in response.
- Carries out management responsibilities for the regulatory team
- Including interviewing, and training employees; planning, assigning, and directing work.
- Liaise with all regulatory contractors.
Compensation: £40K - £55K, depending on experience (+ a performance-based annual bonus).
Employment Type: Full-time, based at our office (with some work from home flexibility when necessary).
Job Location: The Mill, Horton Road, Stanwell Moor, Surrey, TW19 6BJ, United Kingdom.
About Halewood Chemicals: Halewood Chemicals is a producer & distributor of generic pharmaceuticals and raw materials. Based in the United Kingdom, we export all over the world. Founded as a wholesaler of medicines and raw materials, Halewood has since expanded into the development and licensing of own brand generic pharmaceutical finished products and over-the-counter (OTC) healthcare products. The Halewood Chemicals Group was formed by Dr Gordon James Pritchard in 1947. Over the past 70 years, the group has provided healthcare products to healthcare professionals all over the world – from small projects to national tenders. To this day it continues to be a family business, with Dr Pritchard’s daughter, Mrs Susan de Zulueta, the current managing director.