Regional CMS Senior Scientist – International’
This is a key position within the European regional CMC regulatory organization of our company. The successful candidate will be responsible for the development and execution of European Regional CMC strategies for assigned products, including new MAA and mature product lifecycle submissions.
The Regulatory CMC Regional Hub is a key component of Our Company’s strategy to build regional regulatory knowledge, effective local relationships with Our Company country offices in order to deliver appropriate regulatory strategies and right first time regulatory submissions and support conformance of Our Company’s manufacturing practices with registered details. The region includes Europe (EU and non-EU), Middle East and Africa.
Appointment to this position will be on local salary and benefits package.
- For assigned product portfolio, supporting the EU/EEMEA RA CMC Leads who have primary responsibility to develop robust CMC regional regulatory strategies for new marketing applications, Scientific Advice and post-approval changes, as appropriate.
- Working collaboratively with Global CMC RA Product Leads, the team will ensure right first time submissions, high approval rates, on target launches and successful implementation to maintain patient supplies throughout the lifecycle.
- Ensure that the regional CMC regulatory strategy is aligned with the global regulatory strategy, Therapeutic Area portfolio, commercial and operational strategies and the Target Product Profile issues impacting product approval, launch or patient supplies will be appropriately escalated to CMC Regulatory Affairs Management.
- Support our company Country RA affiliate interactions with their local Regulatory Agencies to facilitate Scientific Advice and the prompt review and approval of submissions (as CMC content subject matter expert).
- Act as Regulatory CMC SME in regional post approval requirements and maintain/update the regulatory intelligence repository for Regional markets including communicating proactively with Global CMC Product Leads on regional registration requirements, new legislation and guidance and providing timely update of the CMC change management systems to support right first time submissions.
- Ensure high quality and timely responses to Regulatory Agency questions in Regional markets and fulfillment of regulatory commitments to Regulatory Agency deadlines.
- Support product compliance by ensuring local registrations and lifecycle management align with product manufacturing details.
- Drive continuous process improvement activities within the organization and participate in forums to ensure efficient processes and best practice.
Influence CMC initiatives by internal and external engagement including trade associations and regulators to pursue priority advocacy plans impacting the business.
- Bachelor’s or Master’s Degree in chemistry, pharmacy, biology or a related science.
- At least five (5) years of relevant regulatory CMC experience (covering at least one sub-region of the EU/EEMEA countries). Additional prior experience in the pharmaceutical/device industry including manufacturing, testing, research; or licensure of products would be an advantage.
- Direct Health Authority experience would be an advantage.
- Knowledge of current ICH and local Regulatory Agency legislation and guidance and current hot topics related to pharmaceutical, biological and/or vaccine products.
- Ability to communicate effectively in English (written and verbally proficient).
- Ability to influence and a keen eye for detail.
- Ability to work well under pressure independently and collaboratively in a team.
- Additional qualifications such as PhD degree and language skills are an advantage but not essential.
As a company, we are committed to ‘Inventing for Life’ in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.
So, if you are ready to:
Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.