Overview

Reference Number: JO-2007-451523
EU/EMEA Regulatory Affairs Manager
Rate: Negotiable
Job Type: Permanent
Location: Dublin City Centre

Role: EU/EMEA Regulatory Affairs Manager
Location: Dublin, Ireland
Salary: competitive + benefits
employment: full time, permanent

Job reference:
Regulatory Professionals are collaborating with a global, commercial-stage biopharmaceutical company dedicated to developing and commercializing novel therapeutics to treat patients suffering from serious and life-threatening rare diseases. You will be responsible for the implementation of European regulatory activities and associated oversight of interactions with associated health regulatory authorities. This position is also responsible for oversight and resource planning for Europe (EU and non-EU), Middle East, and Africa.

Other duties will include:
Execute the preparation, submission, and approval of major filings in the region
Support meetings with the European Medicines Agency
Collaborate with EU and global colleagues to ensure unified execution of EMEA regulatory strategy for products primarily for treatment of rare diseases
Responsible for preparation and submission of high-quality regulatory dossiers according to agreed timelines utilising cross-functional interactions, excellent project management and writ-ing skills and good understanding of the underlying science
Work with Regulatory Operations to ensure appropriate planning, preparation and submission of regulatory documentation
Oversee contracted resources throughout the covered region in accordance with objectives and needs
Provide input to EMEA regulatory budget planning
Participate in multidisciplinary study teams and in global regulatory strategy teams to provide regulatory guidance and communicate EU regulatory requirements
Collaborate with regulatory-CMC and manufacturing colleagues to ensure seamless integration of CMC components to relevant submissions
Collaborate with and advise EMEA commercial and medical colleagues regarding integration of regulatory and access strategies
Contribute to developing and implementing patient-focused regulatory strategy
Drive adherence to EU regulations and guidelines
Maintain knowledge of EU competitive landscape, EU regulatory policy environment and par-ticipate in EU regulatory intelligence activities
Develop and direct the activities of EMEA regulatory affairs personnel/external contractors

Requirements:
Right to work in the EU
Advanced degree in a scientific discipline
5 years + prior experience in product development and post marketing Regulatory Affairs in the biopharmaceutical industry, preferably in rare diseases
Experience in dealings with the EMA (scientific advice, orphan designation, PIPs) is an ad-vantage
Well-versed in regulatory strategy, ICH and EMA guidelines
Ability to negotiate and concisely express clear positions to stakeholders at all levels
Excellent written and verbal communication skills
Comfortable speaking to and presenting scientific and clinical data

If you would like to apply for this position, please contact Amani via amani.yousef@Regulatoryprofessionals.com. If you are not currently looking but know someone who would be good for this role then get in touch. We offer a referral scheme at Regulatory Professionals where in which a successful recommendation will earn you 250 worth of vouchers *terms and conditions apply*