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Global Regulatory Affairs Consultant - Belgium
Keyrus Biopharma (company)
Posted on : 13 May 2017
We are looking for a Global Regulatory Affairs Consultant, for one of our clients.
The Consultant will have global responsibility (for Regulatory Affairs) of given activities for product(s) within the client:
- Involved in the Company’s regulatory and administrative (including database entry) activities for this product line worlwide, in Europe, US and elsewhere.
- Participate in cross-functional meetings and discussions with regard to manufacturing and Quality Control changes related to the product with the aim to provide regulatory advice (on submission requirements, classification and strategy) on proposed changes
- Provide input into the content of CMC sections of product specific documents for submission to regulatory agencies worldwide and ensure that these documents meet high scientific standards and regulatory requirements.
- Contribute to the writing of CMC sections of regulatory dossiers
- Ensure the planning, dispatch, submission, follow-up and approval of CMC data-packages to Regulatory Authorities:
- Technical variations, Commitments, Questions & Answers, Scientific Advices & meetings with Authorities, …
The role includes the following responsibilities:
- Provide expert regulatory advice to stakeholders (manufacturing, QC) on technical changes: analyse regulatory impact and propose regulatory strategy in liaison with client line manager
- Ensure the preparation (input, oversight and potential writing) of high quality CMC sections of regulatory documents for submission to Authorities for the product-line
- Coordinate and interact with the internal stakeholders (manufacturing and quality experts regulatory group) for the preparation of submission documents and data-packages in order to meet the submission timelines
- On arrival - training for access to all relevant systems and focused training on preparation on regulatory documentation
- Autonomous learning of manufacturing process of the concerned products via reading and understanding of documents indicated by line manager
- On the job – mentoring on daily RA activities on an “as-needed” basis.
- Master Degree or Ph.D. in the area of Pharmacy, Chemistry, Biology or Medicine
Experience / Knowledge
- Minimum 4-5 years RA experience in the pharmaceutical industry
- Knowledge and understanding of regulatory legislation and guidelines related to CMC, procedural and administrative aspects.
- Previous experience in writing scientific / regulatory documents.
- Experience in preparation of cover letters, application forms, letters of intent and involvement in CTD Module 1 would be a plus
Other Behaviors / Skills:
- Fluent in English, with excellent writing skills.
- French speaking required
- Able to provide regulatory input and evaluate potential impact on regulatory submission
- Able to identify and escalate issues to the client line manager.
- Ability to collaborate with other departments and teams in the delivery of outputs in a timely manner (teamspirit, flexibility and accountability)
- Ability to resolve problems through resourceful use of information and contacts.
- Ability to work in multi-cultural and multi-disciplinary environment.
- Quality mindset.
- Very well organized
- Able to write and critically review documents targeting internal or external audiences.
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.