Director, Regulatory Affairs
Role Location
Newcastle, UK (or Remote UK)
Role reports to
Vice President of Quality, Clinical and Regulatory Affairs
Company Description
Shield is a commercial stage specialty pharmaceutical company with a focus on addressing iron deficiency with its lead product Accrufer®/Feraccru® (ferric maltol). The Group has launched Accrufer® in the US. Feraccru® is commercialized in the UK and European Union by Norgine B.V., who also have the marketing rights in Australia and New Zealand. Shield also has an exclusive license agreement with Beijing Aosaikang Pharmaceutical Co., Ltd., for the development and commercialization of Accrufer® / Feraccru® in China, Hong Kong, Macau and Taiwan, with Korea Pharma Co., Ltd. in the Republic of Korea, and with KYE Pharmaceuticals Inc. in Canada.
Accrufer®/Feraccru® (ferric maltol) is a novel, stable, non-salt based oral therapy for adults with iron deficiency, with or without anemia. Accrufer®/Feraccru® has a novel mechanism of action compared to other oral iron therapies and has been shown to be an efficacious and well-tolerated therapy in a range of clinical trials. More information about Accrufer®/Feraccru®, including the product label, can be found at: www.accrufer.com and www.feraccru.com.
Role Description Summary
The role will report to the VP Quality, Clinical and Regulatory Affairs and provide leadership and oversight for the strategic and operational aspects of the Regulatory Affairs function.
Core Accountabilities
- Lead and manage the development and implementation of regulatory and operational strategies to maximize the likelihood of regulatory success for products within the pipeline. Maintain product registrations globally, in conjunction with licensing partners as applicable.
- Act as a regulatory expert for all original and life cycle management submission for clinical trial and marketing applications
- Communicate significant national and international regulatory changes that impact the business to Vice President of Quality, Clinical and Regulatory Affairs and wider company.
- Serve as regulatory liaison with external partners, including consultants, regulatory and health authorities and trade associations.
- Advise on regulatory requirements to support business strategies, providing appropriate regulatory guidance in regards to requirements throughout the product lifecycle.
- Ensure the development and compliant execution of regulatory strategies for all projects and all their components.
- Collaborate with cross-functional teams to ensure compliance to GMP, GCP, Advertising, Pharmacovigilance and any other regulation having potential impact on the regulatory status of the product(s).
- Participate in the evaluation of in-licensing opportunities.
Required Skills & Experiences
- 10+ years of experience working with major regulatory authorities in a pharmaceutical/biotech company, with at least 3 years of people management experience
- Science graduate (i.e. Pharmacy, Chemistry, Biochemistry). Post -graduate qualification preferred.
- Experience in several of the key therapeutic areas (i.e. hematology, women’s health, GI, CKD) preferred
- Proven record in global Regulatory Affairs with demonstrable ability to build effective relationships with regional knowledge leaders.
- In-depth knowledge of regulatory processes, procedures, guidelines, regulatory strategy, and the ability to integrate them into company-wide goals.
- Effectively participated in face-to-face interactions with relevant regulatory authorities, particularly FDA, at key stages of development i.e. scientific advice meetings, IND meetings, end-Phase II/III meetings, advisory committees, etc.
- Self-starter with a hands-on approach who is energetic, resilient and uncompromising in the pursuit of excellence and delivery of agreed goals.
- Experience overseeing Quality Assurance or Clinical Development an advantage
- Approximately 10% international travel, and regular travel to the Newcastle, UK office (if not local)