ALISON MACKIE
HERTFORD,Hertfordshire
Summary
A CMC Regulatory Affairs executive with 30+ years of experience in the Pharmaceutical Industry, of which over 25 years have been in CMC Regulatory Affairs. Wide range of experience within CMC arena: clinical trials; initial applications and variations. Proven track record of managing staff, leading multi-functional teams, providing regulatory leadership, strategic guidance and resolving CMC issues. Excellent communication skills and technical understanding of pharmaceutical manufacturing and of CMC regulatory affairs.
Overview
34
34
years of professional experience
3
3
years of post-secondary education
Work history
Senior Regulatory Executive (contract), CMC Development Projects
GlaxoSmithKline Research & Development Ltd
Ware, Hertfordshire
2016.07 - 2026.04
- Extensive experience of driving CMC regulatory activities across multiple dosage forms and phases of development.
- Established CMC expert performing key role on Regulatory Networks and Matrix Teams providing regulatory strategic direction and guidance to Preclinical Development (PCD), Manufacturing , Clinical Supplies, Quality Assurance to produce appropriate CMC components for global regulatory dossiers in line with overall CMC regulatory strategy.
- Understands regulations, guidelines, procedures and policies relating to development, registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global CMC applications.
- Thereby, with management oversight, ensuring all appropriate CMC regulatory aspects for clinical trials, product release and stability are in place, to avoid clinical holds, and to ensure continuity of market supply. Ensuring information submitted in marketing applications meets regional requirements, allowing maximum GMS flexibility with minimal unanticipated questions.
- Manages multiple complex project assignments simultaneously and provides data assessment and conclusions within the department with line manager support.
- Formulates novel approaches and influences people, systems and processes.
- Identifies risks associated with submission data and information packages.
- Identifies improvement opportunities for CMC Regulatory processes, policies and systems.
- Understands internal/external CMC Regulatory environment.
- Identifies opportunities to influence internal CMC Regulatory and/or GMS environment.
- Builds organisational networks.
- Communicates across GSK, as necessary regarding CMC project and policy issues ensuring optimum position for GSK.
- Regular communication with line manager to help identify any CMC issues with business impact.
Senior Regulatory Executive (contract)
GlaxoSmithKline Research & Development Ltd
Ware, Hertfordshire
2012.05 - 2016.06
- Deliverance of global regulatory affairs CMC compliance project activities, as required, by effective coordination, strategy and implementation.
- Preparation and review of high quality, accurate and complete, Chemistry, Manufacturing and Controls (CMC) dossiers using varied Global information sources for the full product portfolio, to identify gaps within the local registered CMC information.
- Preparation of detailed plans for remediation project. Managed resource for remediation project across 4 locations. Assigning work to team members and tracking progress towards targets.
- Prepared, reviewed and approved high quality, accurate and complete, Chemistry, Manufacturing and Controls (CMC) submissions and associated response to question submissions to remediate CMC compliance gaps identified during the compliance review.
- Team leader overseeing all aspects of the project: performing gap analysis / risk confirmation and managing remediation submissions. Advising on recruitment and resourcing levels to Senior Manager.
- Contributing to strategic direction of the project and managing deliverance of targets. Proactively pursuing process improvements and sharing best practice.
- Created and maintained good interactions with cross functional teams (Global Manufacturing and Global Supply Chain) and Local Operating Companies within the GSK group to ensure good support for the project from these teams.
Assistant Manager (consultant) CMC regulatory
Mitsubishi Pharma Europe
2011.11 - 2012.05
- Maintained Regulatory CMC related documentation for ongoing clinical trials including:
- Created and maintained IMPD-Q sections. Prepared support statements for storage/shipping deviations for Investigational Medicinal Products. Maintained product specification Files for IMP.
- Reviewed manufacturing documentation from Contract Manufacturing Organisation.
- Provided CMC regulatory advice to Development colleagues for specific project responsibilities.
- Prepared CMC variation for existing licensed DCP product.
Manager. New Business Team, CMC Post Approval Registration.
GlaxoSmithKline Research & Development Ltd
2009.04 - 2011.01
- Manager of the New Business team, created to support the growth of a diversifying business.
- Start-up responsibility for the team and accountable for the integration of acquired products licences into the GSK CMC regulatory function.
- Responsible for managing the regulatory risks associated with the products and for facilitating the growth of the business by ensuring high quality CMC documentation was available to progress new submissions.
- Key aspects of the role:
- Responsibility for regulatory strategy and CMC submissions required for MAH transfers relating to >1000 acquired licences.
- Progressed CMC first registrations in international emerging markets in-line with Commercial priorities, thus enabling rapid expansion of the business. Authoring and approving submission documents to ensure that they were fit for purpose.
- Managed relationship with 3rd party manufacturing, commercial and logistics colleagues both internally and externally to agree ways of working that would facilitate GSK CMC need for business expansion and licence maintenance.
- Accountability for CMC strategy and subsequent submissions in relation to a major remediation project linked to acquired products.
- Propose and agree regulatory strategies with manufacturing /QA functions, leading communications with external regulatory agencies to resolve CMC issues.
- Functioned as department lead for Due Diligence exercises, having gained much experience in this field. Prepared guidance for the department and delivered training for regulatory colleagues in Local Operating Companies.
Regulatory Project Manager, Global Post Approval Registration CMC
GlaxoSmithKline Research & Development Ltd
2003.09 - 2009.03
- Managed a portfolio of products within the team. Responsibility for all CMC interactions including CTAs; initial applications; variations and licence maintenance submissions in non-US markets.
- Key role:
- MDI technical lead for department.
- Held overview responsibility for all MDI post-approval changes and, as leader of a cross-site MDI network, encouraged communication between teams and sites to share innovative strategies.
- Managed regulatory strategy and submissions for major cost of goods initiative relating to an off-patent MDI product. Changes delivered large cost savings to the site at and were successfully implemented.
- Prepared strategy and managed regulatory risks for an MDI JNDA submission, contributing to authoring and review. JNDA approval received in-line with standard timelines and following only minor questions.
- Department specialist on Japanese regulatory requirements and emerging legislation. Managed a cross-function team to facilitate the introduction of major revision to Japanese legislation working closely with colleagues in Japan and across the manufacturing network.
- Seconded to Network Change CMC team to manage a major manufacturing source transfer project. There were significant regulatory challenges associated with the project but I used a meeting with the SFDA in Beijing to gain support for GSK’s plans from the Chinese regulators.
- Seconded to CMC post approval API team for 6 months. Managed more than 15 actives, supporting a major Zidovudine project for the team and creating CEP and DMF submissions for other drug substances. Supervised staff as part of this role.
Regulatory Project Manager, Manufacturing and Supply Rationalisation Regulatory Affairs
GlaxoSmithKline Research & Development Ltd
2000.07 - 2003.08
- Project management of CMC regulatory activities arising from manufacturing and supply rationalisation proposals. Held project responsibilities across the portfolio of respiratory products. Compiled regulatory submissions and provided dossiers to meet the needs of the rationalisation programme, tracking each submission to completion.
- Took leadership role in project teams to obtain accurate information and to formulate complex regulatory strategies to meet the manufacturing site’s needs and deliver approvals in-line with project plans. Travelled to manufacturing sites regularly for face to face meetings.
Conformance Executive, Regulatory Conformance Group
Glaxo Wellcome Operations, Ware
Ware
1997.10 - 2000.06
- Contributed to registration of new products by initiating regulatory strategies with the aim of achieving approval without undue regulatory restriction of company operations.
- Advised on regulatory and compliance requirements for products.
- Took a leadership role in the management of regulatory submissions to support business change projects.
Quality Compliance Officer, Tablet Product Stream Quality Assurance
Glaxo Wellcome Operations, Ware
Ware
1997.01 - 1997.09
- Created Annual Product Reviews for all tablet products manufactured at Ware. Producing and implementing Technical Terms of Supply documents to detail the QA agreement between the manufacturing site and Local Operating Company.
- Producing local quality metrics for the product stream.
- Involvement with self-inspections and Quality Improvement Meetings.
Microbiologist, Quality Assurance
Glaxo Operations, Ware
Ware
1992.05 - 1996.05
- Managed the Environmental Control section of the department. Responsibilities included approval of results for batch release purposes, review of trending data and creation of quarterly reports to the Product Streams pertaining to environmental standards of the manufacturing areas.
- Liasing with production managers to resolve quality issues in the manufacturing areas.
- Provision of GMP training to all levels of staff on the Ware manufacturing site.
Education
BSc (Hons.) - Biological Sciences
University of Leicester
Leicester 1988.10 - 1991.06
GCE A Levels - Biology, Chemistry, Maths
10 GCE O Levels - undefined
Skills
- Strategic visioning
- Project leadership
- Resilience under pressure
- Sales strategy development
- Time efficiency
- Change facilitation
Timeline
Senior Regulatory Executive (contract), CMC Development Projects
GlaxoSmithKline Research & Development Ltd
2016.07 - 2026.04
Senior Regulatory Executive (contract)
GlaxoSmithKline Research & Development Ltd
2012.05 - 2016.06
Assistant Manager (consultant) CMC regulatory
Mitsubishi Pharma Europe
2011.11 - 2012.05
Manager. New Business Team, CMC Post Approval Registration.
GlaxoSmithKline Research & Development Ltd
2009.04 - 2011.01
Regulatory Project Manager, Global Post Approval Registration CMC
GlaxoSmithKline Research & Development Ltd
2003.09 - 2009.03
Regulatory Project Manager, Manufacturing and Supply Rationalisation Regulatory Affairs
GlaxoSmithKline Research & Development Ltd
2000.07 - 2003.08
Conformance Executive, Regulatory Conformance Group
Glaxo Wellcome Operations, Ware
1997.10 - 2000.06
Quality Compliance Officer, Tablet Product Stream Quality Assurance
Glaxo Wellcome Operations, Ware
1997.01 - 1997.09
Microbiologist, Quality Assurance
Glaxo Operations, Ware
1992.05 - 1996.05
BSc (Hons.) - Biological Sciences
University of Leicester
1988.10 - 1991.06