PPD

Senior/Regulatory Affairs Manager - Client Dedicated (CMC Small Molecules, Biologics)

Company
PPD
Location
Cambridge, United Kingdom
Salary
Competitive
Posted
17 Feb 2021
Closes
19 Mar 2021
Ref
1184744
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Senior/Regulatory Affairs Manager - Client Dedicated (CMC - Small Molecules, Biologics)

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.

PPD has an exciting opportunity for a Senior/Regulatory Affairs Manager to join us exclusively for one of our strategic partners.

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.

In this role you will be a pivotal team member with at least 5-7 years of regulatory experience, responsible for driving and leading regulatory CMC strategy.

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.

Qualifications:

The ideal candidate will have:

- 5-7 years of relevant regulatory CMC experience
- 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.

*LI-SH1

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