Regulatory Affairs Specialist Full-time · Leiden
Pharming is a global, commercial stage biopharmaceutical company developing innovative protein replacement therapies and precision medicines for the treatment of rare diseases and unmet medical needs. The company is poised for further scientific, technological and new product development and additional commercial roll-outs. The company is based internationally and growing quickly. As a result of this growth, we are looking for a Regulatory Affairs Specialist for our HQ in Leiden.
About the role:
The Regulatory Affairs (RA) Senior Specialist, in close collaboration with the Director RA, will be responsible for the creation (writing and/or compilation) of documents and adherence to appropriate legislation and regulations pertaining to the biomedical regulatory part of the medicinal product dossier. The RA Biomedical Senior Specialist is aware of the Competent Authority expectations and can pro-actively and independently convey these expectations within the organization.
Areas of responsibilities:
Investigate and analyze requirements for regulatory procedures based on legislation and regulations and ensure appropriate documents are in place. Coordinate with the relevant Pharming departments (e.g. Pharmacovigilance, Medical, Clinical, Marketing & Sales, and Supply Chain) according to the purpose of the procedure, based on the requirements of the (regional) Competent Authorities
Dependent on content expertise, write and/or review, guide, compile, and submit documents (CTAs, PSURs, DSURs, PIP, labelling, Policy 0043/0070 documents, protocols, educational materials, artwork mock-ups, promotional materials) for different regulatory procedures
Guide, coach, teach and/or instruct other Pharming departments on how regulatory requirements can be met
Evaluate compliance of advertising and / or medical information material with (inter)national legislation
Compile, finalize and distribute internally and/or externally regulatory documents such as product information (Module 1.3.1 - 1.3.2), CPPs, etc.
Maintain overviews, archive documents, follow procedures, perform life cycle management activities (e.g. in eDMS)
Ensure that eCTD files are brought and maintained up-to-date
Collect/compose required documents, set-up meetings with relevant stakeholders, create reports/minutes of meetings
Develop regulatory strategies for procedures, take initiatives and gain support for this in the relevant Pharming departments
Participate in project teams. Provide support in biomedical fields of RA to project teams
Act as contact person for regulatory authorities and provide internal and external communication regarding registration requests
Be the contact person for (inter)national partners/sites (such as eCTD publisher, pharmacovigilance provider(s), regulatory consultants, translation agencies, artwork agency/manufacturers)
Act as the internal RA representative in project teams
Act as the RA lead in assigned project teams
Required skills and qualifications in order to be successful in this role:
Independent worker
Accuracy & attention to detail
Excellent writing skills (ability to process complex scientific/medical information)
A structured approach, able to plan and organize, and set priorities
The ability to work independently and be proactive
Collaborative and good communication skills; enjoy working in a multidisciplinary team
Results-oriented
Stress resistant, resilient, and flexible
Knowledge:
A university degree (MSc.) in a relevant discipline such as Pharmacy, Pharmacology, (Medical) Biology, (Biomedical) Pharmaceutical Science
Experience with MS-Word, MS-Outlook, MS-Excel
Knowledge of regulatory procedures and EU guidelines for the content of regulatory dossiers, product information, pharmacovigilance, and drug advertising
Good command of the Dutch and English language in word and writing
Experience:
At least 4 years of experience in Regulatory Affairs
Relevant experience with regulatory procedures and compilation and/or writing of dossier module texts
Experience with eDMS
Experience with eCTD life-cycle management