Manager, CMC Regulatory Affairs

    • Collegeville, PA

Site Name: USA - Pennsylvania - Upper Providence
Posted Date: Apr 13 2020

Are you energized by a challenging role in biology, where scientific demand is driving team growth? If so, this Manager, CMC Regulatory Affairs role would be a great opportunity to consider.

As a Manager, CMC Regulatory Affairs, you will direct the CMC regulatory activities of multiple projects and dosage forms.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following...

  • Represents Global CMC Regulatory, on Regulatory Networks and Matrix Teams providing strategic direction and guidance to Preclinical Development (PCD), Biopharm, Pharma Supply Chain (PSC), Clinical Supplies, Commercial, Quality Assurance, 3rd Party Contract Management and Global Regulatory and Quality (GRQ) on both global project and key strategic business initiatives.
  • May have direct line management responsibility.
  • May participate in corporate evaluation and provide CMC regulatory support/advice to in licensing and divestment projects.
  • Delivers CMC regulatory strategy to support major inspections (e.g.: PAI's) or quality incidents (PIRCs).
  • Understands, interprets and advises on regulations, guidelines, procedures and policies relating to development, registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global CMC applications.
  • Thereby ensuring all appropriate CMC regulatory aspects for clinical trials, product release and stability are in place, to avoid clinical holds, and to ensure continuity of market supply.
  • Ensuring information submitted in marketing applications meets regional requirements, allowing maximum PSC flexibility with minimal unanticipated questions.
  • Ensure all appropriate CMC regulatory aspects within a team to support license maintenance and change control requests including transfer of supply within GSK or with a 3rd party are delivered to agreed timelines.
  • Directs project activities for multiple complex projects and teams simultaneously, including those for reporting staff as appropriate.
  • Provides strategic direction, data assessment and conclusions within and across departments.
  • Formulates novel approaches and influences people, systems and processes.
  • Identifies risks to the business associated with submission data and information packages and provides and communicates well defined risk mitigation strategies.
  • Creates, maintains and continually evaluates/improves CMC Regulatory processes, policies and systems.
  • Likely to be a key individual in designing and/or implementing new and improved procedures to set standards and enhance the efficiency and quality of departmental work.
  • Leads influences and motivates staff within and across departments on assigned tasks.
  • Leads efforts to influence the internal/external CMC Regulatory and/or PSC environment through specialist areas of intelligence.
  • Has established organisational (internal and external) networks.
  • Directs and communicates complex regulatory issues independently across GSK and with external agencies and third parties as necessary, to influence CMC project and policy issues that are aligned with GSK business needs ensuring optimum position for GSK.
  • Able to demonstrate the following key high performance behaviors, customer driven, flexible thinking, and continuous improvement.
  • Operates with considerable independence, except for matters that affect corporate or agency policies.
  • Rapidly and appropriately communicates sensitive matters or those with potential for high business impact.
  • Commercially astute and politically aware and able to deal with sensitive and confidential issues.

Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
  • Bachelor's degree in chemistry, pharmacy or closely related science
  • Detailed knowledge of drug development and manufacturing and supply processes.
  • Detailed working knowledge of worldwide CMC regulatory requirements and demonstrated ability to influence the global internal/external regulatory environment.
  • High ability to manage and direct multiple projects/teams. Successfully influenced and negotiated issues with regulatory agencies and GSK personnel in a variety of settings.
  • Demonstrated ability to handle complex global CMC issues through continuous change and improvement.

Preferred Qualifications:
If you have the following characteristics, it would be a plus:
  • Regulatory Affairs Certification (RAPS).
  • Continued professional growth in global regulatory affairs including communication of evolving/emerging trends and policies.
  • Has identified opportunities to further educate GSK colleagues and formulate GSK approaches to most effectively meet new requirements.
  • Identified as CMC Regulatory expert in a specific subject area.
  • Experienced in supervising and training junior staff and has the ability to motivate and lead others.
  • Continued professional growth in global regulatory affairs including communication of evolving/emerging trends and policies.
  • Has identified opportunities to further educate GSK colleagues and formulate GSK approaches to most effectively meet new requirements.
  • Identified as CMC Regulatory expert in a specific subject area.
  • Experienced in supervising and training junior staff and has the ability to motivate and lead others.

Why GSK?
Our values and expectationsare 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:

  • Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Continuously looking for opportunities to learn, build skills and share learning.
  • Sustaining energy and well-being
  • Building strong relationships and collaboration, honest and open conversations.
  • Budgeting and cost-consciousness
*LI-GSK
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