Regulatory Affairs Manager / Director – Drug Development

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Job TitleRegulatory Affairs Manager / Director – Drug Development
Job TypePermanent
Job Scope
Business AreaBiotechnology/ Orphan Drugs
LocationGalashiels, Edinburgh, UK
Apply OnlineClick here to apply

With an enviable market position of exceptional current and future company growth, you will be joining a committed and valued Regulatory Affairs department to progress key Regulatory Affairs activities associated with worldwide development. This role will offer you the opportunity to develop regulatory strategy, in addition to responsibility for due diligence and the gaining of regulatory approvals for clinical trial and marketing applications.

As Regulatory Affairs Manager / Director, your key responsibilities will include:

• Defining project and product regulatory strategy of the Development Group in line with commercial and company strategy, consulting with appropriate departments where necessary, to include:
o Representation of regulatory affairs at project team meetings for defined projects, providing information, feedback and strategic advice
o Management of the regulatory activities associated with project team plans
• Management of compliance with relevant regulatory legislation and guidelines
• Management of the preparation, attendance and follow-up of meetings with Regulatory Agencies (e.g. requests for scientific advice) including the generation of briefing documents and minutes
• Management of the production of paper and electronic regulatory submissions including applications for clinical trials and marketing authorisations
• Ensuring maintenance of clinical trial authorisations
• Provide support for regulatory activities associated with due diligence for in- and out-licensing activities
• Management of the provision of information requested by regulatory authorities
• Ensuring effective communications between the Development Group and regulatory authorities, licensing partners and country contacts
• Involvement in Regulatory Associates’ development and training

To excel in this position, you will be a Life Sciences Graduate or equivalent with significant experience within the Regulatory Affairs Pharmaceutical or Healthcare arena. With expert Regulatory knowledge, you will want to develop your strategic expertise further by being involved in a spectrum of Regulatory activities across Europe and the US. Key competencies will include:

• Proven ability to lead and manage projects on a global scale
• Excellent negotiation, verbal and written communication, with the ability to understand and present complex scientific arguments
• Strategic thinking with the ability to develop global regulatory strategy whilst balancing local/affiliate needs
• Impressive analytical and problem solving skills, with excellent attention to detail

Kyowa Kirin International is a growing company. For further information on our other vacancies please see the careers section of our website.

Kyowa Kirin Development are part of Kyowa Kirin International plc., a leading biopharmaceutical company with headquarters in Japan whose substantial reinvestment into R&D is creating products at both early and late stage development. With a focus on core business areas of oncology, nephrology, and immunology/allergy, Kyowa Kirin leverages antibody-related leading-edge technologies, including its POTELLIGENT® Technology to discover and develop innovative new drugs aiming to become a global specialty pharmaceutical company which contributes to the health and well-being of people around the world.

We are entering an exciting pre-launch phase with an array of development and in-licensed global products which will join an expanding, successful product portfolio, focusing on cancer supportive care, oncology and bone therapeutic areas.

You will be rewarded with an excellent package, commensurate to the level of this role, and be based in Galashiels within the beautiful Scottish Borders; Edinburgh being only a 50 minute commute away, providing you with the opportunity to truly appreciate the great outdoors and city living. This role will also offer you the opportunity of global travel.

OrganisationKyowa Kirin International
Phone01896 664 000