Regulatory Affairs - CMC specialist - Belgium
- Global regulatory submissions, CMC regulatory - small molecules post approval activities.
Role and main tasks:
- Support for developing and implementing the regional CMC regulatory strategy and submission plans for assigned projects/products to deliver timely approvals to meet business needs in regions assigned, and in line with the global regulatory strategy.
- Identifies supporting documents required for regional submissions and negotiates the delivery of approved technical source documents in accordance with project timelines.
- Responsible for writing regional and global CMC documentation for submissions as agreed with the Global Regulatory CMC Lead or (Global) Regulatory CMC Scientist if applicable, in line with agreed global regulatory strategy, and within agreed timelines.
- Highlights anticipated and ongoing critical issues arising through the product life-cycle in a timely manner to enable communication to key stakeholders as appropriate.
- Contribute to the preparation of the CMC SWOT analysis (or regulatory Risk Capture Document) and supports associated RA CMC challenge sessions.
- Leads or provides support to all CMC related interactions to facilitate and ensure satisfactory resolution of CMC issues and negotiates CMC approvals with Health Authorities in regions assigned, as delegated by the Global Regulatory CMC Lead (or Global Regulatory CMC Scientist if applicable) for assigned projects/products.
- Leads or provides support to cross-functional teams responsible for the preparation of responses to Health Authorities CMC questions raised in regions assigned as delegated by the Global Regulatory CMC Lead (or Global Regulatory CMC Scientist, if applicable) for assigned projects/products.
- Monitors and reacts as appropriate to changes in the CMC regulatory environment in regions assigned for assigned projects/products to support and advice TSO Practice Teams and PVU.
- Establishes and maintains modes for effective communication and collaboration with the Global Regulatory CMC Lead (or Global Regulatory CMC Scientist if applicable), and other teams for assigned projects/products.
- Provides regulatory assessments for CMC changes and creation of entries and updates in the designated systems for assigned regions within defined timelines, as agreed with Global Regulatory CMC Lead (or Global Regulatory CMC Scientist if applicable).
- Provides regulatory affairs CMC input into Practice Teams as delegated by Global regulatory lead or scientist.
- Leads or provides input to internal regulatory business initiatives and cross functional work streams as assigned.
- Effectively works to build relationships and collaborate with people and teams both internal and external to the CMC organisation.
- Is a good communicator that works well in cross-functional teams and in matrix organizational structure.
- Is able to negotiate and influence others to deliver strategies with a global mind set.
- At least 2-5 years relevant experience in the pharmaceutical industry or a regulatory authority in a CMC review capacity
- At least 2 years of experience in Regulatory Affairs CMC
- Preferably 2 years professional experience in pharmaceutical manufacturing, analytical development, and quality assurance/control or related technical field
- Science degree with Biologic experience
- GRA-CMC background with experience in small molecules post approval
- English, (French is asset)
What we offer
- You will receive a competitive based salary depending on your education and experience in an attractive package of extralegal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…).
- Each employee will be welcomed with a varied integration program.
- We invest considerable time and resources in training our staff (technical and non-technical courses).
- You will join a dynamic and international environment with enthusiastic and professional colleagues.
Who We are
- Our company is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence.
- Our ‘human’ approach to service provision is what differentiates us from our competitors.
- Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.
- We’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better
- From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Bio statistics, Medical Writing & Medical Information, Real World evidence services.