Specialities:○ Licensing and post licensing activities for drug products and medical devices○ Liaison with third party contract manufacturers, notified bodies and competent authorities○ Due diligence activities associated with product or company acquisition○ Interim support to overcome regulatory resource constraints○ Regulatory advice for development, outsourcing or in-licensing initiatives○ Preparation and submission of variations and renewals via national or European procedure (CP, DCP or MRP)○ Preparation of labelling master text and co-ordination of artwork creation, review and approval○ Preparation and review of EU medical device technical files

The provision of specialist Regulatory services- To manage the maintenance of regulatory licences- Have responsibility for artwork generation, trademark and regulatory approval of non-Nutritional products- Management and review of Quality Management System in readiness for Competent Authority inspection.

○ Post licensing activities for a range of drug products○ Liaison with third party contract manufacturers, customers and competent authorities○ Preparation and submission of variations and renewals via national procedures for EU, APAC and LatAm territories

○ Product lifecycle maintenance activities for a range of generic drug products○ Interim regulatory management of two regulatory affairs executives○ Preparation and submission of variations and renewals via national or European procedures○ Preparation of labelling master text and co-ordination of artwork creation, review and approval○ Preparation of Marketing Authorisation Application for a new dosage form of a well established combination product

○ Licensing and post licensing activities for inhalation drug products○ Liaison with third party contract manufacturers, customers and competent authorities○ Preparation and submission of variations and renewals via national procedures for EU and APAC territories

○ Manage regulatory teams (7 regulatory affairs professionals) and budget (ca. £900k) in UK, France and Italy, allocating appropriate resources to enable work to be progressed within agreed timelines○ Define the regulatory strategies to enable the registration of various products in key global markets to leverage value○ Ensure Sinclair IS’s continued compliance with legislation for its range of medicinal products, medical devices and cosmetics throughout the EU, Asia and US markets○ Prioritise the regulatory project portfolio in line with the Company’s commercial strategy○ Give advice on internal and external regulatory initiatives ○ Establish and maintain professional working relationships with competent authorities, notified bodies and regulatory consultants○ Ensure the establishment and maintenance of an effective pharmacovigilance system ○ Manage the consolidation of all regulatory documentation into a single repository, ensuring appropriate version and access control, and one version of the truth○ Develop and implement an outsourced artwork process to manage the development and update of all Sinclair artwork components

○ Managing a team of regulatory affairs professionals across two UK sites in order to provide day to day support to New Product Development and routine manufacturing operations○ Define regulatory strategies, working with finished product manufacturers and clinical research organisations in India, to generate data for regulatory submissions in key European markets○ Collaborate with US colleagues to share dossiers for ANDA and EU regulatory submissions○ Attend global scientific affairs team meetings, participating in small working parties to define processes for sharing information, leveraging development opportunities and evaluating business mission/values○ Provide regulatory advice on matters such as reclassifications and product licensing○ Participate in senior management meetings reviewing sales, inventory, project prioritisation and identifying tactical opportunities to increase sales

○ Full life cycle management of a portfolio of products manufactured by external contract manufacturing organisations○ Define regulatory strategies, working with finished product manufacturers to generate data, for regulatory submissions in key European markets○ Provide regulatory advice on matters such as reclassifications and product licensing

○ Definition and implementation of the regulatory strategy to support brand stretch into adjacent therapeutic areas○ Participation in supply chain programmes to reduce cost of goods and decrease complexity, including the evaluation and review of manufacturing opportunities for sterile products

○ Led a small team of Operations Advisors undertaking projects to analyse the operations of the business including the development of a strategy to consolidate the company's information system, aimed at saving £5 million