Job Description
Our client seeks a Regulatory Affairs Lead, who will lead European regulatory affairs, quality systems and compliance for a broad range of Clinical and Commercial medicinal products with EMA, EU and non-EU regulatory bodies. Flexibility exists for this hire, with occasional travel to Dublin site as required.
This role will appeal to a Regulatory Affairs Leader who seeks technical challenge of working on cutting edge technology, including gene therapy products, taking drug product candidate through regulatory process from concept right through development to product commercialisation.
This position requires substantial experience of gaining MAA and CT approvals in the EU and the associated experience of the EU requirements for GMP and GCP as applied to Drug Products, and Clinical Trial Supplies and Manufacture.
The successful candidate will lead a Regulatory Affairs multidisciplinary team; providing direction and oversight of department providing regulatory expertise on Regulatory strategic projects and regulatory activities globally. This includes; ATMP Classifications, Orphan Designations, Scientific and Protocol Advice with EMA and national agencies, PIP applications, PRIME applications providing liaison with EMA and EU agencies.
Key responsibilities:
- Development and execution of regulatory / clinical strategies to support timely approval of regulatory applications in support of the company’s corporate objectives.
- Knowledge and expertise of regulatory pathways in Europe.
- Oversight of preparation of excellent quality regulatory documentation.
- Oversight and coordinating the preparation of core clinical trial approval package for each clinical study.
- Coordinating the preparation of core MAA documentation to support MAA application(s)/variation(s).
- Supporting the regulatory/clinical department to secure national clinical trial approvals on behalf of the companies.
Responsibilities:
- Oversee marketing authorisation applications and clinical trial applications to support exploratory and development projects, ensuring the documentation meets relevant regulatory requirements.
- Oversight of ensuring regulatory compliance for assigned products/projects.
- Oversee the receipt, distribution and response to regulatory queries on the MAA or CT Application consistent with company procedures.
- Responsible for delivering MAA or CTA approvals and subsequent regulatory maintenance procedures in line with company timelines and goals.
- Develop, plan and advise the company on appropriate regulatory submission strategies, and help identify data requirements.
- Act as primary point of contact with regulatory authorities as required.
- Represent the company at meetings with regulatory agencies and other relevant organisations.
Requirements for Regulatory Affairs Lead:
- Bachelor’s degree in pharmacy, a life science or a biomedical discipline.
- 10 years regulatory affairs experience in a CRO, biotech or pharmaceutical company included demonstrated expertise in EU MAA and CT submissions.
- Experience of regulatory affairs for combination products or medical devices is desirable.
- The ability to establish priorities, plan to meet tight deadlines, react to unforeseen circumstances in a demanding busy environment.
- Excellent communications skills required, both verbal and written.
- Excellent organisational skills.
- Superb attention to detail and accuracy.
- Ability to adapt to changing priorities.
Please phone Larry on +353 1-2302400 / larry@rftgroup.ie / www.rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.