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Regulatory Affairs Director - Permanent

Regulatory Affairs Director - Permanent

Company Summary

Our client is a leading Pharmaceutical company with a broad range of products. They are currently seeking a Regulatory Affairs Director to join their team. They are an extremely well reputed organisation and are easily commutable from Hampshire, Berkshire, Wiltshire, Surrey or South or West London.

Role Summary
Working closely with the senior director Global Regulatory Affairs, the Director of Regulatory Affairs will be accountable for developing and directing objectives, policies and programs pertaining to development (in particular early development through to PoC) and marketing of drug products.

Duties and Responsibilities

* Leads the development of strategic plans and tactical implementation leading to the creation and submission of Regulatory documents, e.g., INDs, NDAs., supplemental NDAs and other relevant regulatory filings.
* Designs and implements regulatory strategies to obtain, maintain and extend product registrations.
* Actively works with Regulatory Operations to ensure alignment of regulatory implementation associated with submissions.
*Effectively leads key meetings with Health Authorities to ensure full discussion of issues and opportunities
* Actively trains/mentors junior staff; provides broader guidance on regulatory interpretation to staff.


Qualifications and Experience:

* Higher degree in a scientific field is strongly preferred
* Typically has at least 12 years of pharmaceutical experience with at least 10 years of Regulatory Affairs experience in drug development and registration
* Demonstrated ability to routinely accept empowerment from senior leadership to proactively resolve issues and identify and champion opportunities toward optimal regulatory strategies and implementation.
* Strong competency in understanding regulatory requirements and emerging regulatory landscape associated with the health authority, HA(s), supported by the local staff.
* Experienced in responding to inquiries or complaints from regulatory agencies

If this role is of interest please contact sophie@clinicalprofessionals.co.uk or call +44 (0) 118 959 4990

Key Words: senior Regulatory Affairs Regulatory Affairs director pharmaceutical Biotech CRO drug development life-cycle product management international global european US EMEA FDA Hampshire Berkshire London Surrey Sussex Wiltshire Oxfordshire Buckinghamshire Permanent

We are dedicated to the clinical research industry, offering candidates a unique service including our free \"Pipeline Watch\" career advisory consultation. To find out more call us on 0118 9594990 or email apply@clinicalprofessionals.co.uk