Company: SEC Recruitment
Closing Date: 23 Feb 17
Salary (£): Negotiable
INTERIM HEAD EU REGULATORY AFFAIRSLondon or DublinWe are actively searching for an experienced regulatory professional to join our team on a 12-month basis.SUMMARY:This position in Regulatory Affairs involves continuing the process of building the company’s regulatory profile in the EU, as well as serving as a resource for EU knowledge for the global regulatory and development teams. ...
INTERIM HEAD EU REGULATORY AFFAIRS
London or Dublin
We are actively searching for an experienced regulatory professional to join our team on a 12-month basis.
This position in Regulatory Affairs involves continuing the process of building the company’s regulatory profile in the EU, as well as serving as a resource for EU knowledge for the global regulatory and development teams. The role involves managing the EU regulatory team and the representation of the company to EMA and EU National Agencies, as well as Strategic partners as required. In addition the position assists Regulatory senior management in developing Regulatory strategies that are EU-appropriate and reflect a thorough understanding of EU regulatory systems and processes.
• Develop the EU Regulatory function for the company and increase the regulatory footprint in the EU geography.
• Manage relationships with key regulatory agencies and ensure thorough management of issues emerging in the EU geography that warrant senior level resolution and communication
• Ensure conformance and compliance with regulatory requirements.
• Contribute to global regulatory strategies for assigned programs in collaboration with Regulatory senior management by analysis of EU guidance and assessment of EU precedents.
• Assist Regulatory senior management in developing the strategic acumen of the department by devising creative EU regulatory concepts and proposals within the bounds of the EU legislative framework.
• Build relationships with and provide oversight of our Alliance partners and ensure the EU regulatory strategy meets business objective.
• Provide support to department liaisons with their project specific communications and issues, including Agency meetings, responses to CTA challenges and CRO oversight as required.
• Oversight of all EU regulatory activities associated with company drug development programs, with particular emphasis on late-stage assets.
• Participate in select multidisciplinary project teams and/or joint regulatory teams as appropriate, to provide EU regulatory guidance on the strategy and execution of MAA and CTA filings.
• Perform reviews of clinical protocols and of clinical study reports with respect to clarity, completeness, and regulatory requirements from the EU perspective.
• Continually monitor newly published EC and EMA guidelines in the context of new and on-going development programs.
o Lead the provision of company responses to emerging guidance as appropriate.
o Provide training on emerging legislation for scientific staff as required.
QUALIFICATIONS AND PREFERRED EXPERIENCE:
• Bachelor’s degree in a life science discipline
• Demonstrated ability in European regulatory affairs – this includes comprehensive understanding of regulatory activities for products under development and marketed products
• Ability to understand and communicate scientific/clinical information
• Strong communication skills - both oral and written – and comfortable interacting with senior stakeholders
• Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
3rd Floor, 13-15 Moorgate London.
|Tel:||00 44 (0) 207 255 6600|
|Fax:||00 44 (0) 1483 888997|
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