PPD works in collaboration with this pharmaceutical partner; you will be dedicated to the client projects, processes, working within their teams and systems on behalf of PPD.
You will provide innovative solutions including global regulatory therapeutic area expertise, strategic regulatory intelligence and guidance for product development from preclinical through registration and product optimization. You will feel confident providing regulatory advice and carry out projects in the provision of regulatory affairs services whilst acting as liaison with internal and external clients in the provision of these services.
The ideal candidate will have:
- 5-7 years of relevant regulatory CMC
- Small molecules and biologics expertise
- Expertise in writing CMC sections of the dossier
- Experience with scientific advice attendance and writing
- Proven project management experience and success building relationships across a diverse stakeholder team
Knowledge, Skills and Abilities:
• Excellent interpersonal skills, and oral
and written communication skills
• Excellent organizational and planning skills
• Good negotiation skills
• Ability to work on own initiative
• Good judgement and decision-making skills
• Ability to act as liaison with other departments where necessary
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 values 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.