Senior/Regulatory Affairs Manager - Client Dedicated (CMC Small Molecules, Biologics)
- 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.
- Responsible for developing and implementing the CMC strategy and submission plans for assigned projects/products
- Identifies supporting documents required for (global) submissions and negotiates the delivery of approved technical source documents in accordance with project timelines.
- Ensures that the regional CMC regulatory strategy for the assigned projects/products are consistent with project goals and objectives and meets HA requirements in assigned regions.
- Responsible for writing regional and global CMC for submissions in line with agreed global regulatory strategy, and within agreed timelines
- Ensures effective communication of CMC regulatory strategy, risks, and overall plan for assigned products.
- Highlights anticipated and ongoing critical issues arising through the product life-cycle in a timely manner.
- Prepares or contributes to the preparation of the CMC risk analysis (or regulatory Risk Capture Document) and supports associated RA CMC sessions.
- Leads or provides support to cross-functional teams responsible for the preparation of responses to HA CMC questions raised in assigned regions
- Provides regulatory affairs CMC input for assigned projects/products.
- Functions as regulatory CMC regional representative for assigned projects/products.
- Provides regulatory assessments for CMC / device changes and creation of entries and updates in the designated systems
The ideal candidate will have:
- 5-7 years of relevant regulatory CMC experience
- Small molecules and biologics expertise
- Proven track record of successful authoring and contribution to delivering CMC sections of marketing authorizations for new biological and/or chemical entities
- Experience with scientific advice attendance and writing
- Proven project management experience and success building relationships across a diverse stakeholder team
- Broad background of registration experience gained from working in the pharmaceutical industry or a regulatory authority in one of the ICH regions on development and post-approval products
- Knowledge of GMP requirements and standard systems (e.g. change management systems and tools)
- Experience of direct communication and negotiation with regulatory agencies on CMC matters - preferred
- Experience of participating in regulatory agency meetings on CMC matters - preferred
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.