Principal Regulatory Affairs Specialist - CMC (ATMP)

Submission for the position: Principal Regulatory Affairs Specialist - CMC (ATMP) - (Job Number: 181798)Principal Regulatory Affairs Specialist (CMC) – EMEA

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.

If you’re a strategic thinker, planner and multitasker as comfortable working independently as you are on a team in delivering compliant deliverables based on solid judgment, PPD is the place to be. Our global regulatory experts contribute the regulatory strategy and knowledge to help our clients navigate the challenging regulatory environment — and help get life-changing therapies to patients faster.

As a Principal Regulatory Affairs Specialist for Chemistry, Manufacture and Controls (CMC) - lead focus on Advanced Therapies, you will provide innovative regulatory solutions to our clients.

The purpose of this role is to lead and support Global Regulatory CMC projects across multiple product types with a lead focus on Advanced Therapies (Cell and Gene therapies). This role serves as the lead over several projects in providing innovative solutions including CMC regulatory expertise and client interface to provide strategic regulatory intelligence, and guidance supporting product development from preclinical through registration and product optimization. You will provide strategic, expedient and efficient preparation of client deliverables that meet current local, regional and ICH regulatory and technical requirements and act as liaison with internal and external clients in the provision and marketing of these services.

Essential functions of the role specifically include:

• Application of strong regulatory experience in the area of ATMP - advanced therapy medicinal products (cell and gene therapy products) and biological/recombinant products.

• Preparation of EU dossier applications for genetically modified organisms (GMO)

• Authoring of GMO dossiers and associated regulatory documentation

• Authoring of EU IMPD and US IND Module 3 for biologics, cell and gene therapies and small molecule product types

• Authoring of EMA, FDA, Health Canada, National EU RA, UK MHRA, Scientific Advice and related meeting packages

• Generation of responses to agency questions.

• Client project interface and project management

Additionally:

• You will provide senior review of regulatory documents and submissions created within or outside of the company in order to ensure high quality standards that meet or exceed client expectations, local and regional requirements.

• You will act as subject matter expert in providing regulatory strategy advice to internal and external clients on projects of moderate complexity.

• Provide internal clients with up-to-date legislation and guidance as it becomes available.

• Participate in project management activities to support the provision of regulatory services, and act as liaison with internal and external clients in the provision of marketing these services.

• Provide matrix/project leadership, training and guidance to junior team members to support understanding of regulations, impact on study, assessment of risk, etc., and to achieve a specific goal and/or project deliverables.

• May provide input on performance reviews to management.

• Ensures adherence to project budgets, time schedules, and scope of work.

• Ensures compliance with relevant organizational and regulatory SOPs and WPDs.

• Contributes to business development activities, including project budgeting/forecasting. Principal Regulatory Affairs Specialist (CMC) – EMEA

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.

If you’re a strategic thinker, planner and multitasker as comfortable working independently as you are on a team in delivering compliant deliverables based on solid judgment, PPD is the place to be. Our global regulatory experts contribute the regulatory strategy and knowledge to help our clients navigate the challenging regulatory environment — and help get life-changing therapies to patients faster.

As a Principal Regulatory Affairs Specialist for Chemistry, Manufacture and Controls (CMC) - lead focus on Advanced Therapies, you will provide innovative regulatory solutions to our clients.

The purpose of this role is to lead and support Global Regulatory CMC projects across multiple product types with a lead focus on Advanced Therapies (Cell and Gene therapies). This role serves as the lead over several projects in providing innovative solutions including CMC regulatory expertise and client interface to provide strategic regulatory intelligence, and guidance supporting product development from preclinical through registration and product optimization. You will provide strategic, expedient and efficient preparation of client deliverables that meet current local, regional and ICH regulatory and technical requirements and act as liaison with internal and external clients in the provision and marketing of these services.

Essential functions of the role specifically include:

• Application of strong regulatory experience in the area of ATMP - advanced therapy medicinal products (cell and gene therapy products) and biological/recombinant products.

• Preparation of EU dossier applications for genetically modified organisms (GMO)

• Authoring of GMO dossiers and associated regulatory documentation

• Authoring of EU IMPD and US IND Module 3 for biologics, cell and gene therapies and small molecule product types

• Authoring of EMA, FDA, Health Canada, National EU RA, UK MHRA, Scientific Advice and related meeting packages

• Generation of responses to agency questions.

• Client project interface and project management

Additionally:

• You will provide senior review of regulatory documents and submissions created within or outside of the company in order to ensure high quality standards that meet or exceed client expectations, local and regional requirements.

• You will act as subject matter expert in providing regulatory strategy advice to internal and external clients on projects of moderate complexity.

• Provide internal clients with up-to-date legislation and guidance as it becomes available.

• Participate in project management activities to support the provision of regulatory services, and act as liaison with internal and external clients in the provision of marketing these services.

• Provide matrix/project leadership, training and guidance to junior team members to support understanding of regulations, impact on study, assessment of risk, etc., and to achieve a specific goal and/or project deliverables.

• May provide input on performance reviews to management.

• Ensures adherence to project budgets, time schedules, and scope of work.

• Ensures compliance with relevant organizational and regulatory SOPs and WPDs.

• Contributes to business development activities, including project budgeting/forecasting. Ideally you will have:

• Application of strong regulatory experience in the area of ATMP - advanced therapy medicinal products (cell and gene therapy products) and biological/recombinant products.

• Preparation of EU dossier applications for genetically modified organisms (GMO)

• Authoring of EU IMPD and US IND Module 3 for biologics, cell and gene therapies and small molecule product types

• Authoring of Scientific Advice and related meeting packages

• Generation of responses to agency questions.

• Client project interface and project management

Knowledge, Skills and Abilities:

• Excellent English language (written and oral) communication skills as well as local language where applicable

• Excellent attention to detail and quality as well as excellent editorial/proofreading skills

• Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments

• Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies

• Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects

• Excellent negotiation skills

• Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables

• Excellent understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization; expert knowledge of ICH and other global regulatory guidelines

• Excellent analytical, investigative and problem-solving skills

• Understanding of budgeting and forecasting

At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential.

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing -We are one PPD -

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.

*LI-SH1

As we are likely to receive many applications, sometimes we are unable to provide feedback to everyone.

Ideally you will have:

• Application of strong regulatory experience in the area of ATMP - advanced therapy medicinal products (cell and gene therapy products) and biological/recombinant products.

• Preparation of EU dossier applications for genetically modified organisms (GMO)

• Authoring of EU IMPD and US IND Module 3 for biologics, cell and gene therapies and small molecule product types

• Authoring of Scientific Advice and related meeting packages

• Generation of responses to agency questions.

• Client project interface and project management

Knowledge, Skills and Abilities:

• Excellent English language (written and oral) communication skills as well as local language where applicable

• Excellent attention to detail and quality as well as excellent editorial/proofreading skills

• Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments

• Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies

• Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects

• Excellent negotiation skills

• Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables

• Excellent understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization; expert knowledge of ICH and other global regulatory guidelines

• Excellent analytical, investigative and problem-solving skills

• Understanding of budgeting and forecasting

At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential.

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing -We are one PPD -

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.

*LI-SH1

As we are likely to receive many applications, sometimes we are unable to provide feedback to everyone.

IE-IE-Athlone-Athlone IE Business & Tech Pk, BE-BE-Brussels-Brussels BE St Stevens Woluwe, CH-CH-Basel-Switzerland Basel, ES-ES-Madrid-Madrid ES - Titan, 15, SE-SE-Stockholm-Stockholm SE Sundbyberg, FR-FR-Ivry-sur-Seine Ced-Ivry-sur-Seine Cedex FR PVC, PL-PL-Warsaw-Warszawa PL Signum Work StationIE-IE-Athlone-Athlone IE Business & Tech Pk, BE-BE-Brussels-Brussels BE St Stevens Woluwe, CH-CH-Basel-Switzerland Basel, ES-ES-Madrid-Madrid ES - Titan, 15, SE-SE-Stockholm-Stockholm SE Sundbyberg, FR-FR-Ivry-sur-Seine Ced-Ivry-sur-Seine Cedex FR PVC, PL-PL-Warsaw-Warszawa PL Signum Work StationSubmission for the position: Principal Regulatory Affairs Specialist - CMC (ATMP) - (Job Number: 181798)