Global Regulatory Affairs Consultant/Manager (technical/procedural)
Recruiter in Herent
+32 16 30 95 09
- You will provide support to the supervisor for key regulatory activities pertaining to a project/product.
- Interact with (or represents his/her area/product at) internal project related teams for technical/ CMC and procedural aspects of a given project.
- Participate to project/product-related discussions and provides in-depth strategic, scientific and RA input for technical/CMC and procedural aspects of given project.
- Provide in-depth input into the asset specific regulatory strategy on a global scale for technical/CMC and procedural aspects.
- Provide support to the supervisor via critical review of the technical and procedural section of regulatory documents
- Coordinate (for technical/CMC and procedural part) the determination of key messages for product/portfolio specific regulatory documents to be submitted to Authorities, in collaboration with supervisor
- Compile/write high quality project/product specific regulatory documents to be submitted to Authorities (for technical/CMC and procedural sections) and ensure that those documents meet regulatory requirements.
- Provide input to Vaccines Development Plans by use of appropriate regulatory procedures to secure the optimum submission strategy; contribute for technical/CMC and procedural aspects as needed.
- Facilitate and deliver the regulatory strategy to support the life-cycle of the asset; contribute for technical/CMC and procedural aspects.
- Provide support to the supervisor to assure efficient interactions with the regulatory authorities to achieve on-time approvals of submissions for the asset(s).
- Must be aware of changes in regulatory guidelines and their impact on regulatory strategy for the particular asset(s).
- Develop and motivate collaborators (within RA team or for one of the RA aspects with multidisciplinary teams) to achieve quality output, accountability and recognition across the organization and towards the regulatory authorities.
- Ensure planning and proper organisation of activities (for technical/CMC and procedural aspects) in line with the overall project plan and RA milestones.
- Advanced Scientific Degree, Ph.D. or M.D (preferably biological/chemical, or Pharmacy)
- Knowledge of Regulatory legislation in different geographical areas
- Understanding of biologicals/vaccines
- 5+ years of significant experience in regulatory affairs (CMC/ procedure lifecycle management), or appropriate relevant experience in the pharmaceutical industry. Proven ability to manage typical regulatory activities, resolve problems and deliver results.
- Fluent in English, with excellent writing skills and good communication skills
- Ability to collaborate with other departments and teams in the delivery of outputs in a timely manner.
- Ability to identify and escalate issues to the line manager
- Ability to resolve problems through resourceful use of information and contacts
- Culturally aware
- Enterprise thinking – needs to understand the constraints and drivers of other functions and the potential impact on RA, including how RA may facilitate in achieving the overall goal
- Quality mindset - Ensure rigorous scientific content/quality/compliance of documents intended for regulatory submissions.