Regulatory Affairs Manager

Job Title: Regulatory Affairs Manager
Contract Type: Permanent
Location: Dublin
REF: 124205
Contact Email:
Job Published: over 1 year ago

Job Description

Regulatory Affairs Manager Dublin

Our client is an exciting, rapid growing clinical stage biopharmaceutical business clearly focussed on establishing best in class teams across all its functions. Given the increase in activity within their global business our client is now seeking to fill a permanent position of Regulatory Affairs Manager (RAM), based in Dublin. Reporting to the VP of Regulatory Affairs (RA), the RAM will support all regulatory activities associated with development of product candidates. You will be part of a small and collaborative team which prides itself in producing high-quality work, while working in a fast-paced environment. This role will provide you with the opportunity to contribute to the ongoing success of the business and to be part of its exciting journey.

Job Spec
  • Independently plan and prepare regulatory submissions for FDA, EMA and other international agencies. Coordinate with project team, external consultants and any regulatory vendors in developing and reviewing sections of all regulatory submissions (e.g., INDs, CTAs and associated amendments, scientific advice etc).
  • Act as RA representative on product development teams as assigned. Provide RA strategy in line with corporate objectives to team, with input from RA Management.
  • Oversee submissions made by regulatory vendors to ensure a high standard of quality is maintained.
  • Complete projects in a timely manner consistent with corporate objectives. Proactively communicate project status, regulatory/submissions issues and opportunities to RA Management.
  • Provide RA review of essential study/submission documents e.g. clinical protocols, IBs, CSRs
  • Interface with regulatory agencies on project/products as appropriate with oversight of RA Management.
  • Maintain RA submission and correspondence archives in compliance with document retention policies.
  • Provide RA intelligence to internal stakeholders as needed.
  • Proactively identify changes in global regulatory landscape that may impact activities and assist in preparing the organization for any internal adaptation that may be required.
  • Author, review, and update RA SOPs as needed.
  • Maintain links with external regulatory network, proactively identify training/development needs and identify opportunities to further regulatory knowledge.
  • Maintain a professional and credible image with regulatory agencies, consultants, vendors, and colleagues.

Person Spec
  • Bachelor’s or advanced degree (MS, PhD or MD) in Life Sciences/Health-Related Sciences
  • RA experience in pharmaceutical and/or biotech company of at least 8 years, with a focus on the pre-approval/clinical development/registration application phase.
  • Experience with international (US and Europe) regulatory dossier preparation (e.g. CTA/MAA or IND/NDA), including eCTD requirements. Document owner of full or parts eCTD.
  • Experience of regulatory interactions with key agencies e.g. US FDA, EMA.
  • Knowledge of global regulatory guidelines, GxPs, local regulations and industry best practices.
  • Ability to understand and interpret data/information and its practical application.
  • Experience of technical/regulatory writing (e.g. briefing books, responses to questions).
  • Experience of working with multi-located cross-functional teams including in an outsourcing model using regulatory vendors.
  • Proficient in pertinent software such as Microsoft Office Suite and Adobe Acrobat.
  • Experience across a range of therapeutic areas.
  • Experience with regulatory support of medical device development is a benefit.
  • Experience with regulatory support of development of scheduled drugs is a benefit.
Personal profile
  • Strong attention to detail with exceptionally high standards for document and submission quality.
  • Excellent written/oral communication skills.
  • Excellent organization skills.
  • Team oriented and flexible; ability to function in high volume environment with competing priorities.
  • The attitude and ability to be effective in a lean, small company environment in early-stage research biotech business in pre-revenue/profits phase.
  • Flexible, able to adjust, embrace and drive change.
  • Resilient, energetic, and enthusiastic.
  • An entrepreneurial, business-oriented mindset and a strong fit with the team; willing to “roll their sleeves up”.

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