Job Description
Our client, a fast growing commercially driven multinational pharmaceutical company with a strong portfolio of marketed products including an exciting Oncology portfolio, now seeks a Regulatory Affairs Lead. This is a permanent role and will operate from their Dublin office.
Scope: This hire will manage and lead Regulatory function on site, including overall responsibility for all marketing authorizations, while also working as part of a wider European / Global team participating and leading relevant Regulatory projects. This role will operate within a matrix organization, leading local Regulatory Affairs and representation of such at HQ level.
Offering: This is an attractive opportunity for an ambitious experienced Regulatory Affairs professional looking to grow their career within a Global function. Due to the nature of projects involved, this role offers global visibility for the successful candidate.
Responsibilities of Regulatory Affair Lead:
Ensure timely preparation, submission and follow up of new MA applications to the local NCAs and ensures maintenance of authorized products through timely preparation and/or submission of variations, renewals, PSURs or supplements.
Ensure development registration strategies for the assigned projects and develop processes for the improvement of registration time lines.
Communicate and coordinate the local site's contribution to the EMEA regulatory strategy wherever possible and needed.
Liaise within group and with EMEA colleagues on matters relating to MA strategy, life cycle management and compliance. Key contact for the competent authorities.
Develop and maintain professional relationships with relevant external contacts such as governmental bodies and pharmaceutical industry association, where appropriate
Ensure strategic and operational alignment of RA activities with e.g. Marketing, Sales, Market Access & Pricing and reimbursement and logistics departments to allow the commercial and logistics departments to anticipate and plan product registrations and belonging launches.
Ensure regulatory compliance with company policies, EU and local laws and guidance.
Requirements for Regulatory Affair Lead:
Bachelor of Science Degree. Masters Degree in Pharmacy or other similar Life Science discipline preferred.
5+ years Regulatory Affairs experience within the pharmaceutical industry, including directly dealing with regulatory agencies.
Knowledge of Regulatory landscape and procedures within national and international level.
Good communication, influential, planning and problem-solving skills.
Ability to build and manage close relationships with all relevant stakeholders.
Experience of drug development and pharmaceutical marketing.
Excellent commercial acumen.
Please contact; Larry on 01-2302400 / larry@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. www.rftgroup.ie
Key words; Regulatory Affairs, Regulatory Compliance, Marketing Authorisations, New Product Development, Pharmaceuticals, Dublin, Greater Dublin, Europe, Ireland.