Executive/Senior PPD Consulting Director - Regulatory Affairs - EMEA

Submission for the position: Executive/Senior PPD Consulting Director - Regulatory Affairs - EMEA - (Job Number: 171396)Executive/Senior PPD Consulting Director - Regulatory Affairs - 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.

This outstanding opportunity has become available within our PPD Consulting group and will be based in the UK or Western European countries with close proximity to London. In this key role you will provide regulatory consulting and strategic advice to internal and external clients and serve as senior regulatory contact to our clients, leading interactions and meeting with regulatory agencies on their behalf, with focus on European health authorities.

Your responsibilities in this role would include serving as senior European regulatory strategic lead, providing client portfolio oversight and Regulatory Agency interface. In addition, providing regulatory consulting and strategic advice to internal and external clients to determine the most appropriate regulatory and product development strategy for their products.

This position will also require you to support PPD Consulting as an expert in at least on scientific area. Other responsibilities include, execution of projects, assisting business development and senior management in securing new business, including collaboration with senior US regulatory colleagues for European client assets intended for US development, and actively developing new Technical and Regulatory consulting business.

We are also looking for this job holder to actively promote a teamwork culture within PPD consulting and across PPD as a whole, including collaboration as member of PPD/Evidera Development Consulting with Global Product Development, Regulatory Affairs, providing strategic assessment, impact analysis and product development inflection points for the client asset.

Executive/Senior PPD Consulting Director - Regulatory Affairs - 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.

This outstanding opportunity has become available within our PPD Consulting group and will be based in the UK or Western European countries with close proximity to London. In this key role you will provide regulatory consulting and strategic advice to internal and external clients and serve as senior regulatory contact to our clients, leading interactions and meeting with regulatory agencies on their behalf, with focus on European health authorities.

Your responsibilities in this role would include serving as senior European regulatory strategic lead, providing client portfolio oversight and Regulatory Agency interface. In addition, providing regulatory consulting and strategic advice to internal and external clients to determine the most appropriate regulatory and product development strategy for their products.

This position will also require you to support PPD Consulting as an expert in at least on scientific area. Other responsibilities include, execution of projects, assisting business development and senior management in securing new business, including collaboration with senior US regulatory colleagues for European client assets intended for US development, and actively developing new Technical and Regulatory consulting business.

We are also looking for this job holder to actively promote a teamwork culture within PPD consulting and across PPD as a whole, including collaboration as member of PPD/Evidera Development Consulting with Global Product Development, Regulatory Affairs, providing strategic assessment, impact analysis and product development inflection points for the client asset.

Requirements

Education/Experience:

• Bachelor's degree in a science-related field, an advanced degree is preferred.

• 8 years regulatory experience

• This role requires a suitable level of experience within a broad range of Regulatory Affairs projects with sound knowledge of Global Regulatory Procedures (Drugs/Biologics)

• Strategic European regulatory knowledge and experience across multiple therapeutic areas for Phase I to IV clinical development; scientific areas of potential interest include non-clinical pharmacology, toxicology, and pharmacokinetics; chemistry, manufacturing and control; clinical protocol designs; relevant regulatory precedents for product approvals; and proven track record for successful negotiations with EMA and NCAs

• Demonstrable strategic guidance to Health Authority interactions

Knowledge, Skills and Abilities:

• Broad regulatory affairs experience

• Excellent knowledge of Global Regulations with focus on European regulations

• Strong knowledge of the Global Regulatory Procedures for clinical trial authorizations or marketing authorizations

• In-depth knowledge in one of the medical product discipline areas

• Excellent interpersonal skills

• Strong organizational and planning skills

• Able to manage and plan projects as lead or as member of a team

• Ability to work independently with minimal supervision

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

If you are interested in learning more, please send your resume to simone.hooe@ppdi.com , and we’ll set up a time to connect!

Requirements

Education/Experience:

• Bachelor's degree in a science-related field, an advanced degree is preferred.

• 8 years regulatory experience

• This role requires a suitable level of experience within a broad range of Regulatory Affairs projects with sound knowledge of Global Regulatory Procedures (Drugs/Biologics)

• Strategic European regulatory knowledge and experience across multiple therapeutic areas for Phase I to IV clinical development; scientific areas of potential interest include non-clinical pharmacology, toxicology, and pharmacokinetics; chemistry, manufacturing and control; clinical protocol designs; relevant regulatory precedents for product approvals; and proven track record for successful negotiations with EMA and NCAs

• Demonstrable strategic guidance to Health Authority interactions

Knowledge, Skills and Abilities:

• Broad regulatory affairs experience

• Excellent knowledge of Global Regulations with focus on European regulations

• Strong knowledge of the Global Regulatory Procedures for clinical trial authorizations or marketing authorizations

• In-depth knowledge in one of the medical product discipline areas

• Excellent interpersonal skills

• Strong organizational and planning skills

• Able to manage and plan projects as lead or as member of a team

• Ability to work independently with minimal supervision

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

If you are interested in learning more, please send your resume to simone.hooe@ppdi.com , and we’ll set up a time to connect!

IE-IE-Athlone-Athlone IE Business & Tech Pk, FR-FR-Ivry-sur-Seine Ced-Ivry-sur-Seine Cedex FR PVC, BE-BE-Brussels-Brussels BE St Stevens Woluwe, BE-BE-Zaventem-Zaventem BE Cluster Pk, ES-ES-Madrid-Madrid ES - Titan, 15IE-IE-Athlone-Athlone IE Business & Tech Pk, FR-FR-Ivry-sur-Seine Ced-Ivry-sur-Seine Cedex FR PVC, BE-BE-Brussels-Brussels BE St Stevens Woluwe, BE-BE-Zaventem-Zaventem BE Cluster Pk, ES-ES-Madrid-Madrid ES - Titan, 15Submission for the position: Executive/Senior PPD Consulting Director - Regulatory Affairs - EMEA - (Job Number: 171396)