NEW *** Global Head CMC Regulatory Business Process & Strategic Operations Excellence * Durham / RTP, NC

Reference: TM10576

Expiry Date: 20-01-2022

Categories Biotech, Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Durham County
United States

Apply for position

Job Description

About This Role

This is a leadership team role in one of the most successful biotech companies which has used innovation, prioritizing 1st in Class pipeline development, and their continuing focus on the more stubborn therapy areas where high unmet medical need exists. The organization supports a large number of high value assets and a strong pipeline with a streamlined, flatter organization where matrix level experts and specialists are empowered and driven to be accountable. This structure though does require strong systems, a drive to shape the ways of working, and a leadership team which supports this project and program layer

This team supports many NMEs in pipeline as well as nearly ten blockbuster products globally for lifecycle CMC submissions, across mAb, NCEs, ATMPs, and semi-synthetics. It is a highly successful and high performing team. 

This role is to spearhead with own team of 5 or so, supporting the CMC RA business processes, systems and operational excellence working groups, with an addendum to support their outsourcing partners in certain regions, eg, Asia Pacific, overall to manage globally their CMC submissions and commitments in a streamlined and efficient way, with world-class trackers and CMC related RIM, processes and resourcing models.

This role is to manage this, under the pillars of:-

-           Team, pipeline and submission resource planning and prioritization

-           Budget tracking and support to the LT on budget management

-           Outsourcing Partner strategic frameworks and monitoring

-           Regulatory CMC layer for the QMS and Compliance process and monitoring

-           Comp intell systems and initiatives

-           Developing strategic frameworks (cross-functionally).

In this role, you will be responsible for developing and delivering how to optimize how the Global CMC Regulatory teams execute by identifying and prioritizing key initiatives in the areas of regulatory approaches, processes, systems and tools, and the relationship with Partners. You will help us disrupt and influence and provide strategic input to all these initiatives from inception to implementation.

  • Between 12 and 15 years or more experience in the pharmaceutical/biotechnology industry with 8+ years in Global CMC Regulatory or Regulatory Operations, plus as a minimum a Life Sciences degree (Engineering, Biotechnology, or Pharmaceutical Sciences)
  • Prior experience in a regulatory CMC leadership team whether global or regional
  • Eulogist with strong listening skills: able to draw out threads of information and to engage peers and stakeholders to identify initiatives and opportunities to work more efficiently
  • Strong problem solving and conflict management skills and experiences, keeps calm under pressure, knows how to conseil others to reach satisfactory resolutions
  • Prior experience as a Regulatory CMC Leader, with a track record in developing regulatory CMC submissions in formative part of career ideally both in development and lifecycle
  • Ability to work with different cultures and starting points, locally, regionally and  globally
  • Experience in a structured Project Management methodology, prior experience with new ways of project managing equivalent to Agile / Scrum.

Package & Re-Location

For the right person, my client will buyout stock and bonus losses. The role comes with a high end USD package, as befitting the Director or Senior Director grades, including a high end performance bonus and stock plan. A full relocation package is on offer for this role.



To Apply!

To apply for this role, please press the red “Apply for position” button, or contact me, Theo Moore, for this role by email to or if you would like more information on the role, on 855-505-1382. I will support you throughout the interview and on-boarding experience.

We provide a high level of service because we believe this matters. Our people place individuals at the Specialist, Expert, Regional and Global Head levels, so if you want some advice on when or how to make your next step, or to understand what that next step might look like, let’s collaborate and explore these ideas with each other. ADV Talent Partners only advertise around 30% of our active roles, so for us to really help you, please Register or call us. We provide permanent and contract roles in the following areas, across the USA, Europe and Asia Pacific. General switchboard number 855-505-1382.

GDPR & Data Protection: Your information is safeguarded for GDPR, and you will have the right to edit, amend or delete and ’’be forgotten’’ at any time after your initial registration.