Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms RSS Feed RSS Feeds RSS Feed PharmiWeb Candidate Blog RSS Feed PharmiWeb Client Blog

Job Details

Director Regulatory Affairs

Company: Thornshaw Recruitment
Location: Home based
Reference: LCD9153
Closing Date: 24 Nov 16
Type: Full Time
Salary (£): Negotiable

Job Summary:

Our client, a US company establishing in Europe, are currently recruiting for a Director Regulatory Affairs. This role can be field based in Ireland or the UK.


Our client, a US company establishing in Europe, are currently recruiting for a Director Regulatory Affairs. This role can be field based in Ireland or the UK.

Summary of Job:

The Director, Regulatory Affairs, will be responsible for providing regulatory support to project teams and managing regulatory submissions and related documentation and information.  Principal responsibilities include management of an approved MAA and associated post-marketing study requirements in Europe, including regulatory coordination and support for any corresponding CTAs. In addition, the Director will support, either directly or in alliance with company ’s partners/distributors, the submission of marketing applications to countries in greater Europe (non-EU), the Middle East, and Africa.  Additional responsibilities may include managing US submissions (IND, NDA, etc) and/or collaborating with other regulatory colleagues to assure alignment of post-marketing regulatory activities and a consistency of approach and message, whenever feasible, between US and Rest-of-World regions. As part of his/her responsibilities, the Director will ensure that all assigned regulatory projects are prepared in adherence with US and any other relevant Health Authority regulations, procedures and guidelines.

Essential Duties and Responsibilities:

Assess and communicate appropriate regulatory strategies for fulfilling regulatory obligations and advancing development programs
Review critical documents (e.g., responses, briefing materials, minutes, reports, labeling/artworks, protocols, ICFs) for submission to health authorities, in order to confirm adherence to recognized standards and appropriate regulations and procedures.
Ensure that all development activities are conducted in compliance with applicable regulations and guidelines.
Represent Regulatory Affairs at various project teams and working group meetings, particularly as it relates to regulatory requirements, procedures and activities in the Greater Europe/MENA/South Africa regions.
Oversee select regulatory interactions with corporate development and distribution partners
Manage assigned submission activities including 61(3) notifications, Type I-II variations, PBRERs, CTA submissions/maintenance, PIP submissions/modifications, post-MAA/NDA marketing applications to ROW countries).
Manage and coordinate work with external contract resources, ensuring resources and support are provided, as needed, to meet established timelines and project goals

·         Maintain regulatory communications and compile elements needed for annual reporting requirements including amendments, etc. for all regulatory bodies.

Coordinate health authority communications/interactions (e.g., cover letters, meeting requests and briefing documents)
Ensure the quality and content of assigned submissions to health authorities

·         Coordinate and ensure submissions are prepared and completed to project plans, timelines and budget.

·         Provide regulatory assessment on GXP requirements and questions (e.g. SAE reporting)

·         Review and Draft SOPs, as needed

Job Requirements:

Education:  BS degree in Life Sciences


  • Knowledge and skills acquired typically through a minimum of 10 -15 years’ relevant industry experience in Regulatory Affairs
  • Technical knowledge of and experience with US and European regulations is essential; regulatory knowledge and experience in other relevant regions is a plus
  • Experience across the full scope of Preclinical, Clinical CMC and post market activities
  • Knowledge of GXP guidelines
  • Proven ability to work  effectively in cross-functional teams with internal and external stakeholders and represent regulatory affairs
  • Proven leadership, influencing and project management experience
  • Proven ability to work independently, lead regulatory submissions and manage complex tasks.
  • Proven interpersonal, oral, and written skills.
  • Strong attention to detail and organisation skills
  • Flexible and adaptable in changing environments

Travel Expectation:  20%

For more details on this please call Linda on 01 2784671 to discuss in more detail or send CV to


Apply for this job: Director Regulatory Affairs

Contact Information:

Address:  Head Office
Barton House 6 Old Dublin Road Stillorgan Co. Dublin

Rep. Ireland
Tel:  00 353 (1) 278 4671
Fax:  00 353 (1) 278 4672
Website:  Visit Our Web Site

Share | | |
Site Map | Privacy & Security | Cookies | Terms and Conditions is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.