Director - Global Regulatory Consulting
Stelfox - Cambridge
A great opportunity to working for an established health care service provider, dealing with a range of regulatory affairs responsibilities on European and Global level, this company invest heavily to attract and retain high quality staff.
This position will join a team of regulatory experts in global product development with therapeutic area expertise and strategic regulatory intelligence.
In this challenging and complex role you will be expected to perform the following tasks:
Responsible for providing to stakeholders and advising clients on strategic regulatory considerations for non clinical and clinical(I - IV) product development, study designs; product competitive benchmarking, such as review of relevant regulatory precedents for evolving standards; product label key messaging and rigorous regulatory review for successful registration
Develop and integrate strategic Regulatory Intelligence into Global regulatory strategies and Therapeutic Area(TA)/Subject Matter Expertise (SME) provided to Clients and in support of Bid activities
Responsible for the strategic Bidder role to provide SRI and crucial regulatory considerations to strengthen Bid (together with the regional leads and senior regulatory leads across GRA units)
Active engagement in Business development activities with strategic contribution to GRA Bid process, RFP/ Bid defense to win business - comprehensive product development projects, collaborative and Stand alone Projects
Actively solicit and participate in Bid activities to showcase GRA capabilities and Therapeutic area SRI for potential opportunities to grow business
As the global regulatory strategic lead, Provide client portfolio oversight and Senior regulatory Client and Regulatory Agency interface in strong collaboration with GRD team
Responsible for strategic leadership of the Global Regulatory team
Strategic preparation for Regulatory Agency Advisory/consultation/Scientific Advice meetings-and development of a robust, industry leading, best in class GRC unit
You should have
Broad global regulatory affairs experience
Good interpersonal skills
Good knowledge of the Global Regulations
Proven ability to work effectively in a team
Strong knowledge of the Global Regulatory Procedures for clinical trial authorisations or marketing authorisations
Expert knowledge of ICH and global regulatory guidelines
If you are highly motivated, committed and looking for your next career move, call me without delay for a further discussion, I look forward to hearing from you.
Michelle Jackson (Regulatory Affairs Consultant) + 44 1273 727 930 alternately you can email firstname.lastname@example.org With over 7 years experience in recruitment and outsourcing Michelle specialises in Regulatory Affairs for the pharmaceutical industry. Stelfox - 13 months ago