Regulatory Affairs Manager

Kingston upon Thames, England, United Kingdom · Regulatory · 2019-0010

Description


Would you like to join a company that’s helping patients across the world to see better, in order to live better?

Would you like to join a team that holds Ethics, Respect and Efficiency at its core? Why not put your hard-earned Regulatory Affairs skills to the test in this Regulatory Affairs Manager rolefor Bausch + Lomb within the Bausch Health group.

As the for Regulatory Affairs Manager you will be responsible for Regulatory, Regulatory intelligence, Pharmacovigilance and Medical Information.

More specifically:

Regulatory

· 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 compliance to FMD and complete onboarding process.

· Responsible for all regulatory activities applying to Bausch Health medicinal products (new Marketing Authorisation, MAH transfers, variations, line extensions, withdrawals, renewals…), as well as other types of products included in the Bausch Health 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 Bausch Health 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 Bausch Health 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.

Regulatory Intelligence

· 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 Bausch Health Reg Affairs Headquaters so that registration activities remain at the edge.

· Represent Bausch Health 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.

In order to be successful, we feel you need the following skills and experience:

· 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

· Experience of managing a small team of Regulatory/PV specialists

· Flexible, able to adapt and manage priorities in a fast-changing environment.

· Strong time management skills.


Requirements

In order to be successful, we feel you need the following skills and experience:

At Bausch we encourage you to manage your career and discuss this with your manager in regular catch ups and more formal twice-yearly performance and development discussions. We have a professional qualification policy that will enable you to further your marketing studies with financial support and we encourage you to get involved in projects across the business.

Benefits

It’s also good to know that Bausch has been around for 165 years and that as well as your competitive salary we also have a robust benefits package. Because we believe that life isn’t just about work it’s also about living we have included:

And above all a chance to help preserve the world’s eyes , watch this video to see how important that is to all of us!!


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