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CMC Regulatory Affairs Project Manager

Employer
GSK
Location
Collegeville, Pennsylvania
Salary
Competitive
Closing date
Feb 24, 2021

View more

Sector
Pharmaceutical, Regulatory Affairs
Organization Type
Corporate
Jobseeker Type
Professional
A re you a CMC Regulatory Affairs professional interested in joining a leading pharmaceutical company? If so, this CMC Regulatory Affairs Project Manager role could be an ideal opportunity to explore. We're seeking a highly motivated, self-driven and enthusiastic Regulatory Affairs professional to join our CMC Regulatory Affairs Group. At GSK, our Development Projects CMC regulatory affairs group is responsible for a portfolio of new small molecule and oligonucleotide products.

This role requires you to interact across all the functions of Global Regulatory Affairs to ensure global approaches and strong connectivity. You will play a key part in GSK's commitment to making a difference to patients' lives, enabling them to Do More, Feel Better and Live Longer.

This role can be based at our sites at Ware, Hertfordshire or at Upper Providence, Pennsylvania, USA, however this role will interact across our global network.

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

  • You will manage, or be responsible for, the global CMC regulatory activities for multiple projects/teams simultaneously and respond readily to changing events and priorities.
  • You will be responsible for the strategy development and creation of CMC submission documents from early phase clinical submissions through to marketing applications and early lifecycle activities.
  • You will need to understand, interpret and advise teams on regulations, guidelines, procedures and policies relating to development, registration and manufacture of new pharmaceutical products, to expedite submission, review and approval of global CMC applications.
  • You will work in cross-functional matrix project teams, which include colleagues from regulatory, chemical and pharmaceutical development and manufacturing.
  • You will maintain high quality standards and seek to raise levels of performance through continuous improvement and an innovative approach in responding to the evolving regulatory environment.


Why you?

Basic Qualifications:

  • Bachelor's degree (or equivalent) within a relevant subject such as pharmacy, chemistry or a related scientific discipline.
  • Chemistry, Manufacturing and Controls (CMC) regulatory affairs or chemical and pharmaceutical development experience gained with direct involvement in regulatory submission preparation across all stages of development, through to early life cycle submissions


Preferred Qualifications:

  • Strong verbal and written communication skills with good attention to detail.
  • Knowledge of worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply with these, particularly for new medicines in development.
  • Proven ability to develop and implement regulatory strategies and evaluate the potential impact of them on overall project/product strategy.
  • The ability to successfully influence and negotiate issues at a senior level within the organization and with regulatory agencies in a variety of settings.
  • Excellent team working abilities and effective influencing skills.
  • Ability to find innovative solutions to complex problems and involvement in continuous improvement initiatives.
  • Good time management skills with the ability to effectively plan, prioritize and coordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines.
  • Ability to find innovative solutions to complex problems and involvement in continuous improvement initiatives
  • Experience in sterile products.
  • Experience in drug substance development.
  • Experience of Agency interactions and/or submissions in China .


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:

  • Supporting 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.
  • Sustaining energy and well-being, contributing to building resilience in teams.
  • Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
  • Translating strategy into action - a compelling narrative, setting objectives and motivating others.
  • Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.


*LI-GSK

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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