Are you an experienced Biopharm CMC Regulatory Affairs Leader looking to make a broader impact in developing and commercializing safer and more effective supportive care agents and therapeutics? If so, this Senior Director, CMC Regulatory Affairs Biopharm role is an ideal opportunity to explore! You are responsible for:
- Developing and implementing global CMC regulatory strategies for a diverse portfolio of biologics
- Developing and leading product-specific CMC strategies and overseeing the direction of commercial and clinical products in global markets
- Leading strategic cross-functional initiatives to improve departmental systems and processes
- Establishing strong relationships with key stakeholders including R&D and Supply Chain
- In addition, you play a key part in GSK's commitment to make a difference to patients' lives enabling them to Do More, Feel Better and Live Longer.
- Primary locations: US (Waltham, Massachusetts or Collegeville, Pennsylvania), UK (Ware, London)
- You report into the Senior Director, Department Head of Biopharm CMC Regulatory
- You will have direct line management responsibility for a group of regulatory professionals
This role will provide you the opportunity to lead key activities to progress your career, these responsibilities include some of the following:
- Accountable for CMC (Chemistry, Manufacturing and Controls) Regulatory activities for GSK Biopharm development products, including in-licensed assets through all stages of development
- Accountable for delivering CMC strategy and advice for all GSK development products, ensures timely advice and strategy to project teams in order to secure regulatory approvals for clinical trial, marketing application, and early lifecycle change approvals worldwide
- Provides CMC Regulatory representation to key CMC and GRA governance boards
- Establishes and directs appropriate agency communications including End of Phase 2, Pre-BLA, Scientific advice and ad-hoc product specific agency dialogue
- Ensures risk assessments are conducted and appropriate mitigation and treatment plans are defined for product developments, effectively liaising with business partners and customers development and commercial manufacturing teams
- Provides appropriate GSK representation and input to product specific inspections for CMC aspects to secure approvals of new products and lifecycle changes, and ensure GSK learning and continuous improvement.
- Directs teams which provide the primary interface with development and commercial manufacturing teams
- Responsible for managing direct agency interface for CMC product specific aspects for all GSK Biopharm development assets and for ensuring effective negotiation of CMC agreements on behalf of development and commercial manufacturing teams
- Manage resource requirements
- Accountable for CMC regulatory strategies and submission of global CMC applications aligned with GSK business needs for new biological entities and new dosage forms
- Embraces and drives change in regulatory approaches, seeking new and effective approaches which are aligned with emerging technology, regulatory expectations and applicable laws and regulations
- Manages, coaches, and mentors staff across CMC RA on lifecycle management in CMC.
We are looking for professionals with these required skills to achieve our goals (must-have):
- BA/BSc in a science discipline with 10+ years of regulatory CMC experience with biologics
- Experience across various Biopharm product types (mAbs, therapeutic proteins)
- Experience in formulating regulatory approaches to new and emerging guidance globally and regulatory experience across global markets
- Experience across all stages of Product Development from early development to post-approval
- Expert knowledge of global regulations pertinent to product development and licensure.
Preferred Qualifications If you have the following characteristics, it would be a plus (nice-to-have):
Why GSK? Our values and expectations
- Advanced degree (Ph.D.) in a science discipline
- Proven ability to assimilate new and emerging requirements and establish optimized approaches in global context
- Development experience including previous roles within product development, deep expertise and understanding of regulatory agencies worldwide and proven ability to effectively interface and communicate with global regulatory agencies
- Proven and effective line management capability.
are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigor and risk, governance and control, managing ambiguity and paradox.
- Managing individual performance.
- Creating a performance culture and driving results, prioritization, execution, delivering performance.
- Setting strategic direction and leading on-going organizational transformation.
- Building a resilient organization.
- Building strong relationships and collaboration in service of common goals, engaging the organization and building trusted external networks for mutual benefit.
- Managing P&L and capital allocation.
GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
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