Loading...
Share this Job
Apply now »

 

Let's push the boundaries together and make the most of your talents!

Global Regulatory CMC Lead - Small Molecule

Location: 

Slough, Berkshire, United Kingdom

Job Function:  Regulatory Affairs
Job ID:  65675

Global Regulatory CMC Lead – Small Molecules

UCB – Inspired by patients. Driven by science.

Help us transform patients’ lives.

About UCB

 

At UCB, we put our heart, soul and skills into making a difference for people living with severe diseases. We look to transform patients’ lives by pushing the boundaries of what is possible. With us, our talent makes the most of who they are, unlocking innovation and setting new standards for patients.

 

Everything we do starts with a simple question: “How will this make a difference to the lives of people living with severe diseases?” And to find the answers, we connect globally with patients and their families living with the physical and social burdens of severe disease. These connections give us new perspectives, drive our innovation, and offer a hope for a new generation of therapies that will help to transform lives.

 

To strengthen our Regulatory Affairs Group, we are looking to fill the position of: Global Regulatory CMC Lead – Small Molecules.

 

What We Offer

An opportunity to:

 

  • Define the strategy, planning and preparation of CMC documentation and sections for regulatory submissions from a global perspective to achieve timely approvals to meet business needs.
  • Provides regulatory CMC leadership on the cross functional sub teams (Global Regulatory Affairs (GRA) Teams and Technical & Supply Operations (TSO) Teams) and advises on best practices and/or supports Commercial Teams, as assigned by the GRA-CMC Leadership Team.
  • Lead and ensure adequate provision of regulatory CMC input to all Health Authority (HA) interactions on CMC matters in all regions, as agreed with the GRA-CMC and GRA Leadership Team and the Global Regulatory Lead (GRL).
  • Lead or provide input to internal regulatory business initiatives and cross functional work streams as assigned.
  • Manage direct reports or coach & mentor the staff members and providing input to internal GRA-CMC initiatives and/or cross functional work streams as assigned by the GRA Leadership Team.

 

About the Role

Key accountabilities:

  • Responsible for strategy, planning, definition of content, preparation, review and approval of global CMC submissions for assigned projects/products to achieve timely approvals to meet business needs.
  • Ensures that the global CMC regulatory strategy for assigned projects/products is consistent with the goals and objectives of GRA, TSO and Development and Commercial Teams, and meets HA requirements.
  • Identifies supporting CMC documents required for global submissions and negotiates the delivery of approved technical source documents in accordance with project timelines.
  • Accountable for writing and approval of CMC sections for submissions (i.e. for briefing documents, clinical trial applications, MAA/BLA/NDA registrations, post-approval submissions, PIPs) and responses to health authority questions in line with agreed global regulatory strategy, and within agreed timelines.
  • Ensures effective communication of CMC regulatory strategy, risks, and overall plans to GRA Teams, TSO Teams and Development and Commercial teams through the GRL and Technical Lead (TL).
  • Highlights and proactively communicates anticipated and ongoing critical issues throughout the product life-cycle in a timely manner to key stakeholders (including TSO Teams, GRA Teams, Development and Commercial through the GRL and the TL, as appropriate.
  • Leads the preparation of the CMC regulatory risk assessment or regulatory risk capture document (i.e. global dossier risk analysis and mitigation/resolution strategies) and coordinates the associated RA CMC challenge session.
  • Facilitates capture and communication (within and outside of GRA) of CMC lessons learned from major submissions for assigned projects/products.
  • Responsible for all CMC related HA interactions, including negotiation and satisfactory resolution of CMC issues to facilitate CMC approvals in all regions.
  • Leads cross-functional teams responsible for the preparation of responses to HA CMC questions for assigned projects/products.
  • Monitors and reacts as appropriate to changes in the CMC regulatory environment in all regions for assigned projects/products to support and advise GRA Teams, TSO Teams, Development and Commercial Teams.
  • Provides regulatory affairs CMC leadership on TSO Teams, GRA Teams and Development and Commercial Teams by establishing and maintaining a single point contact on regulatory CMC matters for assigned projects/products.
  • Establishes and maintains modes of effective communication and collaboration within GRA, TSO, CoEs.
  • Establishes regular lines of communication within CoE and across products, including frequent meetings with direct reports.
  • Accountable for the coordination and overall approval (all regions) of regulatory assessments for CMC changes and creation of entries and updates in the designated systems (Trackwise, UPILOT, etc.) within defined timelines.
  • Accountable/responsible for the roles and functions of the Global Regulatory CMC Scientist (if appropriate) for the geographical region in which the Global Regulatory CMC Lead role is located.
  • Represents GRA CMC on due diligence and divestment teams as assigned by the GRA Leadership Team.
  • Leads or provides input to GRA-CMC initiatives and cross functional work streams as assigned by the GRA Leadership Team.
  • Leads or provides input to external industry organisations (e.g. EBE, CASSS, PDA etc.) on CMC matters
  • Participates in recruitment, skill development and coaching of other GRA Practice employees, as required.
  • Responsible for management, coaching and development of direct reports as applicable.

 

About You

You should have:

  • At least 10 years relevant experience in the pharmaceutical industry or a regulatory authority in a CMC review capacity, preferably 8 years of experience in Regulatory Affairs CMC and preferably 2 years professional experience in pharmaceutical manufacturing, analytical development, and quality assurance/control or related technical field
  • Proven track record of successful authoring and contribution to delivering CMC sections of marketing authorisations for new biological and/or chemical entities
  • Broad background of registration experience gained from working in the pharmaceutical industry or a regulatory authority in one of the ICH regions on development and post-approval products
  • Extensive experience of participating in regulatory agency meetings on CMC matters
  • Knowledge of GMP requirements and standard systems (e.g. change management systems and tools)
  • Demonstrated competence in contributing on cross-functional teams and operating within a matrix organisational structure
  • Demonstrated competence in people management and development
  • Specific skills/competences (Include specific skills and knowledge necessary to meet the objectives of the role)
  • Effectively leads globally diverse teams, meetings and discussions to deliver CMC sections  of regulatory submissions for development and post-approval products
  • Effectively defines regional CMC regulatory strategy with global mind set and plans, coordinates delivery of related tasks and objectives
  • Effectively negotiates and influences others to deliver to strategic business and RA CMC priorities in assigned regions
  • Effectively works to build relationships and collaborate with people and teams both internal and external to the organisation
  • Ability to overcome obstacles, drive execution and deliver timely results for products in assigned regions and for departmental projects, as assigned
  • Effectively communicates verbally and in writing in an open, honest and constructive manner while actively listening and empathizing with others

 

About UCB

UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With 7 500 people in approximately 40 countries, the company generated revenue of € 4.6 billion in 2018. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news


Job Segment: Regulatory Affairs, Law, Supply, Pharmaceutical, QA, Legal, Operations, Science, Quality

Apply now »