Are you a highly motivated, self-driven and enthusiastic CMC professional seeking an opportunity to advance your career in the regulatory sciences? If so, this CMC Regulatory Affairs Project Manager could be an exciting opportunity to consider.
As a CMC Regulatory Project Manager, you will be responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of new GSK small molecule and oligonucleotide products.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following.
Why you? Basic Qualifications:
- You will manage, or be responsible for, the global CMC regulatory activities for assigned projects and respond readily to changing events and priorities.
- You will be responsible for the strategy development and creation of CMC submission documents, with managerial support, 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 medicinal products, to expedite the submission, review and approval of global CMC applications.
- You will work in cross-functional matrix project teams, which include colleagues from regulatory, product development, quality 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.
In this role you will require a bachelor's degree (or equivalent) within a relevant subject such as pharmacy, biotechnology, chemistry or a related scientific discipline. You will also possess:
- Minimum of one-year experience in Chemistry, Manufacturing and Controls (CMC) regulatory affairs or equivalent pharmaceutical development experience gained with direct involvement in regulatory submission preparation across all stages of development through to early life cycle submissions.
- Experience demonstrating knowledge of drug development and manufacturing and supply processes.
- Master's degree in a relevant scientific discipline.
- Regulatory Affairs Certification (RAPS).
- Experience demonstrating verbal and written communication skills with good attention to detail.
- Experience demonstrating team working abilities and effective influencing skills.
- Ability to find innovative solutions to complex problems and involvement with 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.
- Experience of Agency interactions and/or submissions in US, EU, Japan and China.
- The ability to successfully influence and negotiate issues at a senior level within your organisation and with regulatory agencies in a variety of settings.
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader inConsumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggestchanges we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022:
New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and geneticsscience; and a new world-leading consumer healthcare company of loved and trusted brands.
With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of diseasetogether - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; andas a new GSK where outstanding people thrive.
Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culturethat is ambitious for patients
- so we deliver what matters better and faster; accountable for impact
- with clear ownership ofgoals and support to succeed; and where we do the right thing
. So, if you're ready to improve the lives of billions, join us at thisexciting moment in our journey. Join our challenge to get Ahead Together.
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.
At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.
GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.
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