Regulatory Affairs CMC Senior Manager – Provide strategic input from PII to CeP for a strong Biotechnology pipeline!

Reference: TM140219A2

Expiry Date: 20-10-2019

Categories Biotech, R & D, Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
London
Greater London
United Kingdom

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Job Description

 

Location: London, UK

My client is a highly rated and extremely successful Biotechnology Company with very good benefits and a culture driven by patient value creation. They have developed a dynamic and multi-cultural working environment that nurtures autonomy and creative thinking and provides opportunities for individuals to excel in a collaborative, team-based environment. This entrepreneurial mind-set fosters diverse perspectives and drives their passion for impact within the sector.

We are leading the recruitment campaign to find an experienced and strategic Regulatory Affairs (Snr) Manager and leader with significant strategic acumen, as well as stakeholder intelligence, for this role. The successful candidate will demonstrate the ability to swiftly build credibility and engagement amongst the team and a broad range of stakeholders and will have sound judgement as well as technically strong CMC expertise/experience. Most importantly, s/he will uphold my clients existing values of working practices, and will be passionately aligned with our client company’s mission statement which is based on patient centric innovation across all departments and stages development.

You will also take responsibility for the following CMC focused challenges. As such, you will:

  • Represent Regulatory CMC at EU and Global meetings with a focus on bringing technical expertise, creativity and innovation as you maximize the business benefits balanced with regulatory compliance for products in Phases I, II & III through to CeP registration.
  • Co-ordinate and drive global regulatory strategy for complex submissions and determine and drives the execution of regional CMC regulatory plans in line with the global regulatory strategy.
  • Proactively communicate CMC regulatory strategy, key issues and any other critical topics throughout the development life cycle in an adequate and timely manner to interdisciplinary project teams.
  • Initiate and lead regional Health Authority interactions and negotiations as appropriate.
  • Provide leadership within the department through specialized matrix functions and by utilizing CMC regulatory expertise to drive improvements.

Experience needed:

  • 4-10 years in Regulatory Affairs CMC with experience in CTA’s/IMPDs and/or MAA’s for the EU region.
  • Knowledge of HA negotiation
  • Project management/leadership experience
  • Strong leadership, negotiation and communication skills

Salary and Package

  • My client company offers a very competitive salary plus Car plus good bonus levels along with a highly rated benefits package and full flexibility around working from home 2-3 days a week.

 

To Apply!

To apply for this role, please register on this web site. My team and I would welcome a phone call in private if you would like to explore this role and opportunity, so please contact Please Contact Theo Moore or Oli Dimitrov  on +44 (0)207 801 3384 or send your CV in confidence to cv@advtalent.com.

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