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Regulatory Affairs Director (All levels) Full-time

de PPD Lisboa em Lisboa (Publicado em 09-08-2022)

Regulatory Affairs Associate Director/Director/Senior Director, Toxicology Regulatory Advising - based in the EMEA region.

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD clinical research services ? 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 clinical research services 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.

PPD has an exciting opportunity for a senior toxicologist to join our team as an Associate Director/Director/Senior Director, Regulatory Affairs within our Regulatory Technical Advising group. In this role you will be a pivotal team member with at least 5-8 years of experience for an Associate Director, 8-10 years for Director, and over 10 years for Senior Director in pharmaceutical toxicology, responsible for driving and leading nonclinical (pharmacology/toxicology) strategy for our clients. This position is based in the EMEA region, can be remote, or based in an office depending on location.

In this role, you will conduct strategic planning and nonclinical program management to enable successful development of small molecules and biologics in stages of development throughout the product lifecycle. You will feel confident providing nonclinical regulatory advice and executing projects while acting as liaison with internal and external clients.

What are the essential functions of the role?

  • Responsible for developing and implementing nonclinical (pharmacology/toxicology) strategy and submission plans for assigned projects/products, together with clinical, pharmacokinetics, and bioanalytical colleague

  • Provide consultation to clients on the design and management of nonclinical development programs from early discovery though regulatory submission for client program

  • Identify required nonclinical studies for regulatory submissions and ensure the nonclinical program supports the manufacturing program and the intended clinical program

  • Provide nonclinical advising and meeting support for successful interactions with global regulatory authorities

  • Prepare/review pre-meeting packages (e.g., pre-IND and Scientific Advice briefing documents) and defend nonclinical programs to regulatory agencies

  • Prepare/review pharmacology/toxicology sections of submission

  • Review and analyze nonclinical data

  • Provide consulting support to assist clients with placement and oversight of GLP and non-GLP studies at preclinical CRO

  • Provide toxicology support for CMC activities (such as impurity and excipient evaluations and risk assessments for extractable/leachable programs)

Education and Experience:

At least 5-8 years for an Associate Director, 8-10 years for Director, or over 10 years for Senior Director of relevant nonclinical (toxicology) experience, including as a toxicologist in the pharmaceutical/biotechnology industry or at a regulatory agency
A broad background of nonclinical regulatory experience on products from discovery/early development through post-approval, gained from working in the pharmaceutical industry or at a regulatory agency in one of the ICH regions
Toxicology certification (Diplomate, American Board of Toxicology or European Registered Toxicologist) highly desirable but not required
Small molecules and biologics expertise (cell and gene therapy experience is highly desirable but not required)
Proven track record of successful authoring /contribution to delivering nonclinical sections of INDs/CTAs and marketing authorizations for new biological and/or chemical entities
Experience with regulatory agency meeting preparation and attendance, including negotiation with regulatory agency representatives
Proven project management experience and success building relationships across a diverse stakeholder team
Knowledge of ICH, FDA, and EMA guidances and GLP requirements

Knowledge, Skills and Abilities:

Excellent English language communication and negotiation skills, as well as local language where applicable, both oral and written
Excellent understanding of global drug development throughout the product lifecycle, with emphasis on nonclinical disciplines; superior understanding of ICH and other global nonclinical regulatory guidances.
Advanced understanding of budgeting and forecasting with the ability to interpret data with attention to detail and analytical and investigative skills
Capable of driving innovation in developing new ideas related to process improvements
Excellent organizational, judgment, analytical, decision-making and interpersonal skills to manage complex projects in parallel and manage rapidly changing priorities
Effective computer skills, including the use of Microsoft (MS) Word, MS Excel, Adobe Acrobat, etc.
Capable of independently assessing sponsor needs and working with project team members in producing compliant deliverables
Capable of independently learning new technologies
Capable of effectively acting as a liaison with other departments

At PPD clinical research services 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 clinical research services 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 clinical research services 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.

Our 4i Values:
Integrity ? Innovation ? Intensity ? Involvement
If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world?s most urgent health needs, submit your application ? we?d love to hear from you! #LI-REMOTE


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