Sunil Singh Email & Phone Number

Rapid response regulatory affairs, CMC, scientific services support to the pharmaceutical industry. - growing network of consultant partners and specialists, with a core team of project/client managers- utilising and deploying industry-leading concepts and strategies

Phuturum believes that every pharmaceutical company can unlock its full regulatory affairs execution potential. Powered by its data and submission and knowledge core platform, we provide a means to automate non-complex data driven regulatory activities, eliminating millions in regulatory inefficiencies, compliance burdens and personnel costs and driving critical medicines and healthcare to patients 10x faster.

Independent Consultant to the Pharmaceutical Industry, in Regulatory Affairs, Regulatory Strategy, CMC and provision of Outsourcing. Project and Programme Management. Delivery of Rapid Response Regulatory Affairs support to wide client base.www.sksconsulting.co.uk

Contract Placement - Project Manager and Team Lead for Brexit Project for large multinational clientProject Manager and Team Lead for urgent site ownership and MA transfer project for full product portfolio of large multinational organisation.Senior Regulatory Lead for diverse projects, including generic oncology MAA submission, scientific advice, importation of unlicensed medicines, labelling

Contract Placement - Several large scale compliance initiatives and LCM projects, including working as client manufacturing site regulatory lead. - Complete Module 2 (QOS) and 3 (substance and product) authoring, review, conversion for established product portfolios for Pharmaceutical, Generic and Consumer medicines and sterile injectables - Planning, co-ordination and implementation of manufacturing compliance remediation strategies for UK EU, US and ROW with cross-functional teams- LCM/extension projects including range rationalization (branded product differentiation - coating, markings, packaging) - Project (manufacturing site) management and line management - Team development, training and mentoring for compliance and remediation

North East England

Contract Placement - UK/IE regulatory department - support for department lead and specific LCM initiatives/programmes and department resourcing (3 personnel)- CMC dossier compliance review and update, CTD conversions, QOS authoring- Batch specific variations / labelling / post approval for all UK/IE OTC medicines, herbals and food supplements; product information updates with CCDS- Readability user testing and bridging reports - UK THMP update to core dossier

Contract Placement- Part of team managing Stiefel UK/ GSK Integration - Licence Transfer project (EU markets)- CMC Regulatory and Labelling support for EMEA region, predominantly UK and IE- Management of internal labelling projects including Nordic affiliate office closure

Contract Placement- Decentralised and national informed consent immunological vaccine registrations- 2nd round MRP veterinary pharmaceutical submission in 13 member states- Veterinary immunological dossier update for repeat use MRP- Support for new EU accession countries/affiliates to gain European registrations

Contract Placement- EU/UK/3rd country Pharmacovigilance ADR reporting- MRP veterinary licence renewal and Centralised variation/labelling- Promotional material and technical queries

South Yorkshire

Management of a regulatory department providing support for NPD, LCM and routine manufacturing operations- UK Regulatory Department build from 1 to 4 FTE, implementation, budgeting and oversight - Implementation of departmental procedures and change management system- Due diligence for all in-licensing opportunities, life cycle extension strategies for existing portfolio, divestitures and regulatory input for Business Development opportunities- LCM of established national product licence portfolio for brand and all retail own-labels- Development projects (OTC formulations), WEU and Informed Consent MAAs- Direct facing to customer, trade associations and all Agencies, including MHRA (broad scope regulatory and SA meetings)- Regulatory process improvements (systems, SOPs)- Product reclassifications

• Regulatory strategic advice for MAA submissions• Module 3 dossiers, CTXs, expert reports, packaging texts/leaflets and SPCs• Liaison with Regulatory Authorities • Business development activities, including external workshops & conferences • Including successful secondment to GSK Ltd, UK

Bsc 1St, Chemistry

Education record