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Collins McNicholas

Regulatory Affairs Manager

Overall Purpose:

This dual-focused position is responsible for:

  • Contributing to regulatory strategy development, technical writing and project management for CMC regulatory submissions as part of the European Regulatory Affairs team to support the companies global regulatory and manufacturing activities with its investigational and marketed ophthalmic products, with a primary focus on the EU and secondarily the US, and
  • Being the regulatory affairs lead, managing regulatory related processes and tasks, and providing regulatory guidance in support of manufacturing activities at the companies manufacturing facility in Athlone, Ireland. 

 

Duties and Responsibilities:

 

European CMC Regulatory Responsibilities:

  • Contribute to strategy development for CMC regulatory submissions. Provide guidance on submission classification, applicable regulatory guidances, supporting scientific/technical data requirements, submission planning and contingency.
  • Assist in authoring and/or critically review of CMC submission documents, taking account of regulatory standards and data requirements, to support high-quality regulatory submissions including investigational and registration applications (e.g. EU MAAs and variations, US NDAs and supplements and CTAs/INDs and amendments) and responses to regulatory authority questions.
  • Support interactions with regulatory authorities as needed, including providing input to meeting requests, preparation of supporting documentation and attendance at meetings where appropriate.
  • Provide input to Change Control items including review of supporting data and regulatory assessment of change impact to registered details.
  • Manage submissions to regulatory authorities as required e.g. post-approval variations pertaining to quality aspects of a registered dossier.
  • Provide general regulatory advice and assist in preparation and management of other types of regulatory documents and submissions when required.
  • Monitor, interpret, and provide guidance on current developments in regulatory guidances, regulations, practices and policies in CMC areas relevant to the companies regulatory and manufacturing activities.
  • Represent Regulatory Affairs at various project teams and other meetings when required, particularly relating to CMC regulatory requirements, procedures and activities for EU, US and ROW.

Athlone Manufacturing Plant Responsibilities

  • Regulatory lead at the site, managing site and manufacturing related regulatory projects (in partnership with Global RA teams) and providing general regulatory guidance and support for the companies manufacturing activities in Athlone, Ireland, including;
  • Licensing of plant for US and EU manufacturing through creation and submission of relevant dossiers and supplements to existing and/or planned regulatory filings, in collaboration with regional Regulatory teams where appropriate
  • Ongoing maintenance activities for CMC filings as they relate to the Ireland plant
  • Assessment of global change controls for impact and management of the activities associated with regulatory submissions/approvals
  • Work closely with site QA to evaluate and assess impact of proposed changes from a regulatory perspective

Other Responsibilities

  • Verify accuracy of documentation presented to regulatory authorities.
  • Complete projects in an assertive manner consistent with corporate objectives.
  • Proactively communicate project status, regulatory issues, and opportunities to supervisor.
  • Author, review, and update standard operating procedures (SOPs) as required; ensure SOPs are in compliance with current regulatory requirements.
  • Participate in development/review of CMC-related protocols and evaluation of technical data/reports where relevant to a regulatory submission.
  • Assist in evaluation of technical issues and provide guidance on possible impact on regulatory filings and reporting obligations, as applicable.

Qualification Requirements:

Education & Experience

Bachelors or advanced degree (MS, PhD or MD) in Life Sciences/Chemistry with at least 8 years of European Regulatory Affairs experience in a pharmaceutical or biotechnology company and at least 6 years in a CMC Regulatory role, preferably in the ophthalmic therapeutic area and/or involving sterile solution formulations.  Experience of US FDA regulatory submissions.

Knowledge & Abilities

  • Knowledge of global regulatory guidelines (FDA, EMA, ICH, etc.) and best practices.
  • Technical knowledge and experience with European and US regulations.
  • Knowledgeable in international dossier preparation (e.g., IND/CTA/NDA/MAA/NDS), including electronic document submissions (i.e., eCTD).
  • Ability to integrate scientific and regulatory considerations in developing and implementing regulatory strategies.
  • Proficient in pertinent software, such as Microsoft Office Suite and bibliographic software
  • Excellent written/oral communication skills.

For a confidential discussion and more information on the role, please contact David Lennon on 090 64 78104 or email david.lennon@collinsmcnicholas.ie

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