Senior Director, Regulatory CMC Policy

3 weeks ago

Cambridge, Cambridgeshire, United Kingdom Turner Regulatory Full time
Senior Director, Regulatory CMC Policy & Intelligence

Superb senior role in Regulatory CMC Policy & Intelligence and a key hire for a dynamic and fast-growing Biopharma. Leadership, influencing and advising skills both internally and externally.

This outstanding role requires the candidate to provide EU Regulatory Intelligence expertise in order to steer the development and execution of Regulatory CMC Policy for the organisation. Possessing good relationships with Trade Bodies - the EFPIA, and Regulatory Authorities - the EMA, MHRA and other European National Authorities along with other key internal and external stakeholders is essential to the role. Other non-EU countries could be within the remit of this role (non-USA).

The ideal candidate will have operated in Regulatory CMC to a senior level prior to entering Regulatory Policy & Intelligence.

The candidate's duties and expertise will encompass:
  • Identification of EU Regulatory Policy & Intelligence issues/trends/changes occurring in the market that have the potential to impact the company's products
  • Advice on the adaptation of Product Strategies accordingly in order to enhance products' probability of success
  • Actively engagement externally to shape the EU policy environment in line with the company's objectives
  • Operate within cross-functional teams: Commercial/Medical/Regulatory/Government Affairs etc. and actively engage externally to shape the EU policy environment in line with company priorities and objectives
  • Set policy agenda and engage directly in EU Regulatory advocacy and promotional activities
    The candidate will set the agenda and collaborate with other Senior Management in relation to the company's positioning and statements on the external environment and prevailing issues.

    Establish and influence the company's promotional voice in the market. Identify and respond to EU Regulatory/legislative policy issues that impact on R & D, Development, Registrations and Life-cycle Management.

    Provide thought leadership in regard to in EU Regulatory policy and to and maintain/develop mutually beneficial relationships with key leadership at Regulatory Authorities.

    Join and actively participate in EU external committees and coalitions (i.e. major trade associations, public private partnerships, academia etc) in order to influence policy, if appropriate. Advise on Regulatory Strategy, Development, Registrations and Post marketing activities obtained from deep knowledge/understanding of Regulatory external/competitive environment. Develop Communication channels between all cross-functional teams and other interested parties that may impact on the business.

    This is a significant role and a key hire. The candidate will need to demonstrate excellent Leadership, influencing and strategic skills whilst interacting at multiple levels internally and externally.

    A significant salary package is offered to the right candidate. This highly successful Biopharma is growing at a fast pace; this is a significant commercial opportunity. Cambridge location but there is some work flexibility. Travel could be required in this role.

    If you are interested in this, or any other Regulatory Affairs roles, please contact Julian Turner, at Turner Regulatory Recruitment, on / , or by , or submit an application by clicking Apply Now.

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