Director Regulatory Affairs

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Job TitleDirector Regulatory Affairs
Job TypePermanent
Job Scope
Business AreaOrphan Drugs
LocationHome based work, with travel to Paris office
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An unique and exciting opportunity for an experienced regulatory professional looking to work for an entrepreneurial late stage development pharmaceutical company in the orphan disease space. This position is ideal for a candidate who is seeking autonomy and responsibility at a highly strategic level as part of the senior executive team.

The Company

GMP Orphan (GMPO) is a late stage development pharma company, located in Paris and founded in 2013. It is backed by a major European Venture Capital Fund. GMPO is a portfolio company of Advent Life Sciences. The company’s focus is the potential best in class product in development of an oral dosage form for an orphan disease.

GMPO has filed for approval in Europe and is expecting to obtain approval by mid 2017, with expected commercialization towards the end of 2017. Likewise, an IND in the US has been submitted, and the company plans to start a pivotal trial for the US mid 2017, with an NDA submission planned early 2018. In both Europe and the US, the company has orphan designation for its product.

A permanent Regulatory Director is now urgently required. Currently GMPO employs senior regulatory consultants for ad hoc advice. However, in order to meet the increasing needs of the company a full time in-house regulatory professional is highly desired.

Director Regulatory Affairs

The right candidate for this role will be a self-starter with strong experience of clinical development and regulatory filings. S/he will manage all ongoing interaction with the EMA and FDA.

As a direct report to the CEO, s/he will be responsible for managing regulatory and quality functions to support pharmaceutical drug development and clinical operations. The appointee will coordinate all strategic regulatory activities and work with vendors.

Candiate Profile


The ideal candidate is an experienced regulatory professional with a strong track record operating at Director level. This is an operational role and is finalizing the approval and labeling discussions in Europe and post approval life cycle management of the regulatory dossier. The candidate will lead FDA discussions and lead the preparation of the NDA submission in 2018.

Key responsibilities:

• Oversee preparation and assembly of clinical, preclinical and CMC information for submissions of INDs, NDAs, amendments, supplements, and annual reports
• Contribute to assessment of regulatory strategy
• Review documents (IRB approval, 1572 Forms, Financial Disclosure, Annual Reports, Protocols)
• Support the production, assembly and publishing of submission documents
• Coordinate submission related activities between departments
• Act as liaison to e-submission vendors
• Prepare materials for meetings with FDA and other Regulatory Agencies
• Review and approve specifications, methods, procedures, study protocols and reports
• Ensure compliance with regulatory standards, procedures and practices
• Interpret regulation and guidance requirements and provide updates to the executive team
• Provide strategic input to executive management

Preferred Qualifications:

• Bachelor’s degree in science or relevant related field
• Minimum of 10 years of industry experience with increasing responsibilities
• Strong submission management experience and exposure to regulatory strategy
• Experience at adapting the quality system through a drug development program as products advance from clinical trial to commercialization
• Strong knowledge of GMP, GLP and ICH regulations
• Experience with pharmaceutical clinical trials
• Lead auditor in a minimum of five supplier quality audits
• Direct experience with FDA audits
• Excellent negotiation, verbal and written communication
• Impressive analytical and problem solving skills with excellent attention to detail


Competitive salary GBP, reflecting the seniority and responsibility of the role. Bonus of 20-25% and Stock options. Although GMPO is based in Paris, this position does facilitate working from a home base location with travel to Paris as and when required.

For further information and to apply for this role contact:

Sophia Kamlin
Mobile: +44 (0) 7850 311 581

Phone+44 (0) 7850 311 581