Regulatory Affairs Manager
The UK Bausch + Lomb team is currently recruiting for a Regulatory Affairs Manager UK&I to join our Kingston office. Reporting into the Senior Director Regulatory Affairs Europe and based in our Kingston office, you will be part of the Global Regulatory Affairs Team managing the UK&I team and responsible for Regulatory controls for the Pharma business, and support the pharmacovigilance, quality and GDP effort across the business.
To Manage the UKI regulatory affairs team
- To manage copy approval on advertising and promotional materials.
- Support the advertising material workflow and sign-off process in relation to the local regulatory responsibilities
- Ensure minimal impact on the business during Brexit.
- Ensure compliance to FMD and complete onboarding process.
- Responsible for all regulatory activities applying to Valeant medicinal products (new Marketing Authorisation, MAH transfers, variations, line extensions, withdrawals, renewals…), as well as other types of products included in the Valeant portfolio (food supplements, devices, aesthetics & cosmetics):
- Define the regulatory needs, write and compile the national data and provide advice on appropriate strategies to manage various in-country submissions.
- Contribute to the maintenance of assigned to the Valeant product portfolio.
- Contribute to due diligence procedures by assessing the quality of the registration/ certification file.
- Ensure that all labelling is compliant with the national requirements and the company’s master documents/ CCDS.
- Contribute to the internal process to provide mock-ups using the appropriate tools.
- Contribute to the establishment of the products launch plan in the territory so that all regulatory activities can be anticipated and performed in due time and business is informed of the regulatory expected timelines.
- Support compliance initiatives via SOP development and management.
- Supervise the activities of any RA consultants as applicable.
- Update of key stakeholders and all existing Valeant relevant country regulatory databases with any updated regulatory product information.
- Assist the team during product recall and field safety actions.
- Ensure timely and high quality reporting.
- Build and maintain suitable relationship with the Competent Authorities and ensure efficient communication. Act as primary Regulatory contact for national Competent Authority in the UK and Ireland.
- Track and anticipate changes of national regulations or in authorities’ organisation and practice, and communicate internally including Valeant Reg Affairs Headquaters so that registration activities remain at the edge.
- Represent Valeant and contribute in Regulatory Associations or Working Parties, especially concerning medicinal products and food supplements.
Pharmacovigilance/ Medical Information
- Provide back-up support for LPM UKI.
- Manage the MI & PV officer to ensure adherence to company policies, deadlines and minimise exposure to risk.
kills / Qualifications:
- Proven regulatory experience in a similar function (experience with Medicinal Products is a must, experience with Food Supplements and Cosmetics is an asset)
- In-depth and practical knowledge of regulatory processes.
- In depth knowledge of applicable legislation in force in UK and Ireland
- Strong knowledge of European and local laws and regulations for Medicinal Products is essential. Good knowledge of laws and regulations for Food Supplements and Cosmetics is desirable.
- Acquainted with MHRA and HPRA processes and people, and ability to communicate effectively in order to foster decisions or feed-back
- Experience of submission databases within UK and Ireland PV directive
- Good understanding of business processes
- Ability to manage a small team of Regulatory/PV specialists
- Excellent communication skills – written and verbal
- Ability to manage complex tasks in a matrix environment
- Flexible, able to adapt and manage priorities in a fast changing environment.
- Strong time management skills.
- Strong interpersonal and relationship building skills
- High attention to detail and accuracy
- Good planning and organisational skills
- Good computer skills, including Excel, Word and PowerPoint
In this role for Bausch + Lomb you will benefit from a good package that will include:
Pension Matched by us up to 10% (conditions apply)
25 days holiday with the ability to buy 5 more
Fresh fruit, hot and cold drinks provided
Free product scheme for you and a family member (includes contact lenses and eye supplements)
Dental and Travel Insurance (voluntary benefit)
Bausch + Lomb, established in 1853, has been at the forefront of many of the visionary innovations in eye health from optical lenses to contact lenses, from eye drugs to surgery. As a successfully performing healthcare company we relentlessly pursue our mission to help patients across the world to see better, in order to live better.
With a performance culture based on “people, attitude and results”, we have passion for winning and entrepreneurial spirit that will suit any individual with a “get up and go” attitude, strong work ethic and appetite to make real, tangible impact in a constantly evolving environment.
The UK organisation employs today around 150 staff, fostering a “small company” mindset with the comfort of a large financial backer from the wider Valeant group. We take pride in a team that is wholly dedicated to working in strong collaboration with each other and sharing knowledge and skills readily in order to further the unified company success.
If you want to help the world to see better, in order to live better, please click Apply Now. You will then be re-directed to the Bausch + Lomb site to complete your application.