Experience

Actelion (now Janssen Pulmonary Hypertension)

• Switzerland
• Pharmaceutical Manufacturing
• 500 - 600 Employee

• Regulatory Affairs Manager

  • Feb 2019 - Present

  Main responsibilities• Respond to questions from local Health Authorities in cooperation with Global DRA • Ensure that regulatory commitment, local reporting requirements as well as local risk minimization activities are fulfilled towards the national competent authority (e.g. controlled distribution system, prescriber kit) • Coordinate with the Affiliate, Medical Director, on the Risk Management Plan and Risk Minimization Measures for Actelion products • Review and approve promotional and educational materials against approved Product• Acting as a compliance and QP back up• MAA license Maintenance, Variation, Renewals, withdrawal etc• Planning and contributing in Brexit strategy



Parexel

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Regulatory Affairs Manager

  • Sep 2018 - Feb 2019

  Main responsibilities• Labelling compliance strategy. Perform Gap Analyses of Product Information (i.e. CCDS vs SmPC/PIL) and assess impact on findings.• Reviewing and confirming gap analysis findings. Support in developing remediation strategy across markets• Preparing CTA for Regulatory authority in EU and non EU-countries• Developed effective regulatory strategies asa Global Regulatory Lead• Prepare the clinical trial applications to support exploratory and full development programs, ensuring the documentation meets relevant regulatory requirements. Worked with Clinical teams and advised them on appropriate regulatory strategy when co-coordinating multi-center clinical trials• Participate in project team meetings and sponsor teleconferences for initiation activity regulatory and ethics approvals.



Chr. Hansen

• Denmark
• Biotechnology Research
• 700 & Above Employee

• Interim director of Global regulatory affairs

  • Sep 2017 - Jul 2018

  Main responsibilities• Managed a team of 14 regulatory affairs professionals located in Denmark and coordinated a global network of regulatory affairs professionals located in MENA, LATAM, North America, and APAC regions reporting to the regional sales heads.• Managed 5 regulatory divisions this include Plant health, Animal health, Natural colors, Human health (probiotic supplement and infant formula), Food culture and enzyme• Responsible for designing, implementing processes & tools allowing the Chr Hansen organization to deliver on its products’ compliance. As it’s a global bioscience company that develops natural ingredient solutions for the food, nutritional, pharmaceutical and agricultural industries.• Bi-weekly meetings with each team member, tracking of progress on individual objectives, advised/support on operational tasks owned by team members• Monthly GRA team meetings



Takeda

• Japan
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Associate Director Regulatory Affairs

  • Jan 2017 - Jul 2017

  Main responsibilities• Collaborated to define, develop and lead global and regional strategies to maximize regulatory success towards achievement of program objectives. Effectively communicates objective assessments of the likelihood of success of these regulatory strategies. Provides strategic and tactical advice and guidance to teams to achieve timely and efficient conduct of development programs and/or oversight of marketed product support, while maintaining full compliance with applicable regulatory requirements.• Provided regulatory expertise for multiple projects • Managed team members • Leasing with CRA for CTA submission and reviewing submission package • Managed submission package for EU and global markets this include QC, proof reading etc.• Coordinated global labeling in line with SPC update for centralized, national and MRP products.• Coordinated and oversee EU translations of artwork in respond to HA queries • PIP submission and responding to queries• Monitored and informed on emerging trends, regulations and changes, with emphasis on those related to project areas and/ or region of responsibility enabling proactive approach and planning to future business requirements.• Act as the main contact with health authorities for project(s). • Calibrating with internal and external partners in diverse cultures



PAREXEL International

• Regulatory Affairs Manager

  • May 2015 - Jan 2017

  Main responsibilities• Primarily acting as a Parexel Project Lead (PPL) to manage, facilitate and coordinate the delivery of submissions within a given project timelines• Responsible for regulatory submissions throughout the product life cycle globally – EU, North Africa (FSA), Asia, Gulf & LATAM by coordinating with local teams • The planning, coordination and oversight of all processes involved in gaining approvals required in each country for a projects.• Liaising directly with Health Authorities and third party vendors to support regulatory application• Coordinate collection of functional documents in support of regulatory applications • Involved in Project forecasting, activity and submission trackers • Provide regulatory support to Commercial, Medical and Clinical departments through cross-functional interactions in brand and therapeutic area teams• Responsible for the preparation and maintenance of labelling to support MAAs and other post-licensing activities. Ensures that any updates to the Product CCDS are implemented in a timely manner. Liaises with affiliates and/or third parties to co-ordinate translational activities and the subsequent submission of language versions to HA.• Liaises with regulatory, manufacturing and other parties as appropriate, to ensure that updates to the product packaging components are implemented in line with approved labelling for new MAAs or variations affecting the labeling, and in line with required timelines, for products registered globally• Liaises directly with local Affiliates, distributors or agents to define/clarify submission requirements, and follow up on submissions, requests for supplementary information and approvals with specific country and/or regional • Managed a small team(4-6) globaly



Sanofi

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Regulatory Manager

  • Aug 2014 - Apr 2015

  Main responsibilities• Plan, participate and supervise the technical review and preparation of primary submissions and variations to the MHRA and Ireland, • Manage review and prepare, artwork changes for UK and Ireland i.e. in line with change of ownership, site transfer• Managed the review, preparation, submission and follow-up of regulatory submissions in the UK, • Managing the personal and professional development of colleagues within my team. Main responsibilities• Plan, participate and supervise the technical review and preparation of primary submissions and variations to the MHRA and Ireland, • Manage review and prepare, artwork changes for UK and Ireland i.e. in line with change of ownership, site transfer• Managed the review, preparation, submission and follow-up of regulatory submissions in the UK, • Managing the personal and professional development of colleagues within my team.



AMCo (Amdipharm Mercury Company Ltd)

• Regulatory Affairs Manager (consultant)

  • May 2012 - Jun 2014

  Main responsibility• Management and preparation of rest of the world (ROW) technical and MA transfers (non EU) + maintenance of established product licences.• Review and preparation of the safety variations following critical finding from MHRA inspection in UK, Ireland, • Management and coordination of safety variation in EU and the rest of the world (ROW) using affiliate’s and partners on establish products.• Regulatory strategy, project manages regulatory submissions to agreed project targets. • Provide operational regulatory input and guidance in cross-functional teams.



Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Regulatory affairs executive

  • Sep 2011 - May 2012

  Manage and Submit Marketing Authorisation Applications:• National/MRP/Decentralised- Review, co-ordinate and create necessary technical data to support UK/Irish submissions e.g. provide national specific module 1 data (PIL, labelling)• Review and approve proposed regulated documents (SPC, PIL, and Labelling) and associated artwork in line with regulations.• Submit Periodic Safety Update Reports to MHRA and IMB.• Submit MA Renewal Applications Manage and Submit Marketing Authorisation Applications:• National/MRP/Decentralised- Review, co-ordinate and create necessary technical data to support UK/Irish submissions e.g. provide national specific module 1 data (PIL, labelling)• Review and approve proposed regulated documents (SPC, PIL, and Labelling) and associated artwork in line with regulations.• Submit Periodic Safety Update Reports to MHRA and IMB.• Submit MA Renewal Applications



Sinclair

• United Kingdom
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Regulatory consultant

  • Aug 2010 - May 2011

  Main responsibility• Managing MA transfers in EU, Asia and mina countries,• Managing the maintenance of licence this include renewal, Type IA, B and type II variations• Gap analysis on the Flammacerium dossier• Advising on other development projects and prospective pre-clinical and clinical data, which may form parts of new IMPD, CTA, IND’s.• Reviewing labelling and Patient Information leaflets to ensure compliance with current legislation for it to be released in the marketCorresponding with the National health agencies e.g. MHRA, Afssaps and FAMHP



Reckitt

• United Kingdom
• Manufacturing
• 700 & Above Employee

• Senior Regulatory Affairs consultant

  • Jan 2010 - Feb 2011

  • Managing the maintenance of licence this include renewal, Type IA, B and type II variations • Switch application• Corresponding with the National health agencies e.g. MHRA and Irish Medicines Board• Reviewing labelling and Patient Information leaflets to ensure compliance with current legislation for it to be released in the market• Review of documentations from departments outside Regulatory Affairs ie marketing, medical, PV, manufacturing, Quality Assurance, Labelling, Operations functions and R&D. Provides advice with applicable Department Director consultation as to regulatory acceptability of plans for drug development and marketing of the product• Ensuring consistency of readability testing, liaising with external groups (package user-tests vendors), as appropriate.



Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Global Regulatory Affairs Manager

  • Aug 2009 - May 2010

  • Managing the regulatory aspects of projects/products, including applications (CTA, renewals, variation etc) submitted to regulatory agencies. • Developing effective proactive regulatory strategies for global product development, CMC, labelling or promotional issues, and recommends such strategies to RA Team Leader, Team Members and/or supervisor, as appropriate with minor oversight.• Interfaces directly with governmental regulatory personnel, including scientific reviewers, administrative staff and management, to facilitate the review and approval of regulatory applications. Plans and facilitates formal meetings and teleconferences with regulatory authorities.• Review of documentations from departments outside Regulatory Affairs. Provides moderate advice with applicable Department Director consultation as to regulatory acceptability of plans for drug development, CMC, labelling or advertising/promotion through individual as well as RA Team and Interdepartmental Project Team contacts.



Cephalon

• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Regulatory Affairs

  • Jul 2008 - Aug 2009

  • To prepare the Type I and Type II variation applications, Licence renewal applications, approval of UK, Ireland artworks, change of ownership applications and general regulatory requests to MHRA & IMB• Prepare, update and implement labels and leaflets to ensure compliance with marketing Authorisations• Worked closely with functional areas throughout the company. Advises functional areas regarding content requirements for regulatory submissions. Critically reviews documents from functional contributors for consistency and completeness



MDS Pharma Services

• United States
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Regulatory consultant

  • Jan 2008 - Jul 2008

  • Prepare the clinical trial applications to support exploratory and full development programs, ensuring the documentation meets relevant regulatory requirements. Worked with Clinical teams and advised them on appropriate regulatory strategy when co-coordinating multi-centre clinical trials including countries like Korea, India, China, Poland and Brazil• Review promotional materials for compliance with relevant national and EU legislation and codes of practice• Participate in project team meetings and sponsor teleconferences for initiation activity (regulatory and ethics approvals) as well as maintenance activity in the EU, non-EU countries in Europe, South Africa, Australia, New Zealand and Latin America.



Ipsen

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Regulatory Consultant

  • Jul 2007 - Dec 2007

  • General regulatory affairs activities as requested. This included post licensing activities including variations Type I and II’s. The preparation of clinical trial applications and liaising with regulatory agencies to ensure compliance with requirements and responding to queries.• Manages the EU registration procedures in EU (Centralised or Mutual Recognition)• Preparing and compiling various sections of the CTD with specific emphasis to non clinical sections of CTD.• To review and comment on protocols/briefing books and reports relating to preclinical, clinical and CMC development.• Worked closely with functional areas throughout the company. Advises functional areas regarding content requirements for regulatory submissions. Critically reviews documents from functional contributors for consistency and completeness



Biogen

• United States
• Biotechnology Research
• 700 & Above Employee

• Regulatory Consultant

  • Jan 2007 - Jun 2007

  • Preparation and/or review and/or submission of clinical trial Application documents• Coordinate and work with project teams to identify/selection of countries, identify essential documentation for the submission in accordance with country specific requirements.• Tracking of individual projects for the regulatory submissions and approvals.• Support project teams in development of regulatory strategy for EU and national regulatory advice by International Regulatory Development and to develop the advice dossier with project teams.• Preparation and/or review and/or submission of marketing authorization Application documents• Attendance at relevant internal and external meetings including project team, regulatory and clinical team meetings and if applicable external partners meetings.• To work on Development strategy with project teams to develop regulatory strategy for assigned projects.• Liaison with Contract Research Organisations for initial Regulatory submissions and follow-ups on queries and Amendments. Preparation and/or review of standard operating procedures etc• Review and interpretation of Directives, guidelines etc• Ensure that regulatory approvals remain in compliance with their authorisations and with current regulatory requirements. This includes scrutinising and making recommendations on all relevant documents • Foster constructive and professional working relationships with all contacts – internal and external – so that applications are submitted and approved expeditiously



i3 Research

• Senior Regulatory Affair Associate

  • Oct 2005 - Dec 2006

  Co-ordinate Regulatory and ethics submissions• Define a regulatory strategy for the study.• Provide sponsor/PM with a list of all regulatory documents required to make submissions.• Review and prepare regulatory documents for submissions• Arrange translations of regulatory documents as required• Prepare and make Regulatory and Ethics submissions, with the assistance of the project team as required• Track submissions, with the assistance of the project team as required• Make submissions of Amendments, IB updates, annual reports etc. as requested by the PM.• Provide PM/Sponsor with regular regulatory status updates as required• Arrange payments of Ethics Committees and Regulatory Authorities Ensure that regulatory approvals remain in compliance with their authorisations and with current regulatory requirements. This includes scrutinising and making recommendations on all relevant documents e.g.• Labelling, patient information leaflets and data sheets to ensure conformance with appropriate current requirements.Foster constructive and professional working relationships with all contacts – internal and external – so that applications are submitted and approved expeditiously.



Winthrop Pharmaceuticals

• Regulatory Officer

  • Jan 2005 - Oct 2005

  Managing company name change by preparing and submitting updated artwork components to the PIU (Product Information Unit) for UK, Ireland and International Markets• Preparation and submission of IA/B variation applications • Preparation and submission of Marketing Authorisation Renewals• Corresponding with the National health agencies e.g. MHRA and Irish Medicines Board• Reviewing labelling and Patient Information leaflets to ensure compliance with current legislation. • Maintaining and updating regulatory databases• Producing technical files for products