Job Description
As RA Manager, you are responsible for the regulatory management of products (Vaccines). You will manage the content of relevant technical/CMC sections of project/product specific documents, ensure proper planning and execution of regulatory submission packages (e.g. technical variations, responses to questions or commitments) worldwide and will resolve as needed supply related issues that may arise. It may involve both maintenance of regulatory dossiers as well as new dossier submissions. You will be required to communicate both internally and externally, to maintain/update various databases and planning tools associated with the role as well as writing documents technical and procedural in nature.
Responsibilities
- You provide support to the supervisor for key regulatory activities pertaining to a project/product.
- You interact with (or represents his/her area/product at) internal project related teams for technical/CMC and procedural aspects of a given project.
- You participate to project/product-related discussions and provides in-depth strategic, scientific and RA input for technical/CMC and procedural aspects of given project.
- You provide in-depth input into the asset specific regulatory strategy on a global scale for technical/CMC and procedural aspects.
- You provide support to the supervisor via critical review of the technical and procedural section of regulatory documents.
- You 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
- You 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.
- You provide input to Vaccines Development Plans in order to optimise the label by use of appropriate regulatory procedures to secure the optimum submission strategy; you contribute for technical/CMC and procedural aspects as needed.
- You facilitate and deliver the regulatory strategy to support the life-cycle of the asset; you contribute for technical/CMC and procedural aspects.
- You provide support to the supervisor to assure efficient interactions with the regulatory authorities to achieve on-time approvals of Vaccines submissions for the asset(s).
- You are aware of changes in regulatory guidelines and their impact on regulatory strategy for the particular asset(s).
- You 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.
- You ensure planning and proper organisation of activities (for technical/CMC and procedural aspects) in line with the overall project plan and RA milestones.
- You have an Advanced Scientific Degree, Ph.D. or M.D (preferably in biology/chemistry, or Pharmacy)
- You have significant experience in regulatory affairs (CMC/ procedure lifecycle management), or appropriate relevant experience in the pharmaceutical industry. And, a proven ability to manage typical regulatory activities, resolve problems and deliver results.
- You have a strong knowledge of Regulatory legislation in different geographical areas and a good understanding of biologicals/vaccines
- You are fluent in English (business), with excellent writing skills and good communication skills
- You have a strong Team spirit
- You are enterprise thinking – you understand the constraints and drivers of other functions and the potential impact on RA, including how RA may facilitate in achieving the overall goal
- You have a quality mindset - you ensure rigorous scientific content/quality/compliance of documents intended for regulatory submissions.