REGULATORY AFFAIRS CONSULTANT, PHARMA HF

Job description

About the Company:
CaduCeum provides its customers with its expertise in the pharmaceutical, medical devices and cosmetics industries
This expertise is of high importance: for our clients, it is a synonymous of know-how, and for our consultants it’s the assurance to gain expertise and experience. Beyond its technical knowledge, the leverage of CaduCeum is in its human-focused management.
With its experience in this highly restrictive regulatory environment, CaduCeum supports its customers, in all phases of industrial development, from product design to market launch.
Our expertise has been recognized by our clients for 5 years, thanks to our robust team of expert consultants and the presence of our Technical Direction team which ensure the smooth and successful completion of each mission Of each mission
Job description:
As a Regulatory Affairs Consultant, you will work with our clients on the following missions:
- Perform internal QC of any submission.
- Proactively communicate the status of ongoing projects and submissions to the manager.
- Assist and provide training to others on software tools and publishing procedures.
- The candidate shall have experience with electronic CTD (eCTD) publishing software, as well as an understanding of regulations and guidelines to ensure eSubmissions compliance.
- The candidate must have experience in the Irish and UK market (MHRA, HPRA)
- The candidate will be implementing submission standards where applicable.
- The candidate will be responsible for ensuring that all final electronic deliverables meet current regulatory electronic document requirements and guidance.
- The candidate will have to deal with Questions and answers with British and Irish Health Authorities
- Candidate will prepare submissions and applications in the Common Technical Document (CTD) in electronic formats with some additional paper requirements as appropriate.
- The candidate must also be detail-oriented, thorough, and methodical.
- The candidate shall establish and comply with standard operating procedures for publishing regulatory submissions.
Assist in ensuring product packaging and associated information is updated and maintained in accordance with product licenses, in international territories (especially UK and Ireland) including the review of artwork for product packaging and provision of accurate labelling translations.
Required profile:
The ideal candidate will be degree qualified with a BS degree or a MS degree with relevant experience. You should be experienced in electronic document management systems, global regulatory submissions, or other experience directly related to Regulatory Operations. As well as this, you must be able to balance multiple tasks simultaneously to achieve goals and satisfy customers.
As a Regulatory consultant, you will also possess the following characteristics:
- Excellent verbal, and written, strong organizational and time management skills and strong attention to detail.
- Must be able to master new technical skills and apply them to projects as the industry, and the company evolve.