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Senior Director, Regulatory CMC Policy & Intelligence - top Biopharma

Employer
Turner Regulatory
Location
Cambridgeshire/flexible, UK
Salary
Competitive
Start date
1 Jun 2024
Closing date
1 Jul 2024

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Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

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 0203 695 9477/07 447 977 330, or by julian@turnerregulatory.com, or submit an application by clicking Apply Now.

Company

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Brief Company Description; 

Turner Regulatory Recruitment is headed by Julian Turner, whose knowledge of Regulatory Affairs Recruitment is significant, and connections with talented candidates in this area unsurpassed.

Julian Turner started his regulatory recruitment career in 2005, since when Julian and his team have created an outstanding database of candidates and other contacts who are always happy to take our calls.

Our candidates willingly engage with us because we have taken the time to get to know them and to understand their plans and their career ambitions. Indeed, it is quite likely we placed them in one of their roles over the past 15 years.

We work closely with our clients’ regulatory line/senior management, HR and talent acquisition/internal tecruitment teams. When they have a Regulatory Affairs vacancy, they rest assured knowing we will put forward on average ten or more exceptional candidates.

We are often called in where other recruiters have failed and are able to fill long-standing vacancies quickly and effectively.

We are proud to work with clients such as Roche, Norgine, BioMarin, Vertex, Shire, ReNeuron, Seqirus/CSL and numerous other organisations, successfully placing candidates in permanent and contract roles within Regulatory Affairs.

If you have a Regulatory Affairs vacancy and would like the opportunity to select from a pool of excellent candidates, please contact Julian and the team at Turner Regulatory Recruitment.

 

 

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Company info
Website
Mini-site
Turner Regulatory
Telephone
0203 695 9477
Location
71-75 Shelton Street
Covent Garden
London
WC2H 9JQ
GB

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