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CMC Regulatory Affairs Project Manager

Site Name: UK - Hertfordshire - Ware RD, Durham Blackwell Street, UK – London – New Oxford Street, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper ProvidencePosted Date: Dec 10 2024Would you like to drive change and transformation efforts that enable successful regulatory outcomes for GSK? If so, this Chemistry, Manufacturing and Controls (CMC) Development Projects Regulatory Project Manager role could be an ideal opportunity to explore.As CMC Development Projects Regulatory Project Manager you will be responsible for the CMC regulatory activities in the in the investigational, late phase development and/or early commercial lifecycle management of Small Molecule GSK products.You will work in cross-functional matrix project teams, which include colleagues from regulatory, development, quality and manufacturing ensuring adequate interaction and partnership in order to define proper regulatory CMC filing strategy.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.We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSKIn this role you will• Be responsible for the global CMC regulatory activities for assigned projects and responds readily to changing events and priorities.• Be responsible for CMC strategy development, with managerial support, for CMC submission documents from early phase clinical submissions (IND/IMPD) through to marketing applications (NDA/BLA/MAA) and early lifecycle management activities in accordance with the applicable regulatory & scientific standards• Understand, interpret and will sometimes 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.• Ensure all appropriate CMC regulatory aspects for clinical trials/product release are in place, to avoid clinical holds and/or to ensure continuity of market supply. Ensure information submitted in clinical/marketing applications meets regional requirements, allowing maximum Supply/Production/Quality flexibility with minimal unanticipated questions.• Ensure regulatory compliance is maintained and shares best-practices and learnings within the CMC Regulatory teams and other impacted functions.• Engage in CMC Subject Matter Expert activities internally (for increased compliance, harmonisation and efficiency)Why you?Basic Qualifications & Skills:We are looking for professionals with these required skills to achieve our goals:• BSc or equivalent in chemistry, pharmacy or related scientific discipline• CMC Regulatory Affairs or product development experience with direct involvement in regulatory submission preparation across all stages of development through to early life cycle submissions.• Sound knowledge of drug development / manufacturing processes and may have a specialized area of expertise.• Knowledge of worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply with these, particularly for new medicines in development.Preferred Qualifications & Skills:Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:• Master’s degree in life sciences or related scientific discipline; Regulatory Affairs Certification (RAPS)• Experience in influencing and negotiating with company personnel and with regulatory agencies in a variety of settings.• Proven ability to develop and implement regulatory strategies and evaluate their potential impact on overall project/product strategy.• Good time-management skills with the ability to effectively plan, prioritize and co-ordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines.• Strong verbal and written communication skills with good attention to detail.• Excellent team working abilities.Closing Date for Applications – 16 Dec 2024 (COB)Please take a copy of the Job Description, as this will not be available post closure of the advert.When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We’re uniting science, technology and talent to get ahead of disease together.Find out more:Our approach to R&D.Why GSK?Uniting science, technology and talent to get ahead of disease together.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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, 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*(*US only).We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on Ukdiversity.recruitment@gsk.com or 0808 234 4391.Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a UK Recruitment FAQ guide. Click the link and scroll to the Careers Section where you will find answers to multiple questions we receiveAs you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.
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What You Should Know About CMC Regulatory Affairs Project Manager, GSK

Are you ready to take the reins as a CMC Regulatory Affairs Project Manager with GSK in Waltham, MA? This dynamic role is your chance to drive change and transformation efforts that lead to successful regulatory outcomes for our small molecule products. You'll be immersed in the exciting world of Chemistry, Manufacturing, and Controls (CMC) project management, working closely with cross-functional teams to define effective regulatory CMC filing strategies. Your expertise will be key in navigating the investigational, late phase development, and early commercial lifecycle. We believe in maintaining high-quality standards and fostering continuous improvement. As part of GSK, you'll enjoy a culture that values teamwork, diversity, and innovation. Alongside a competitive salary and comprehensive benefits, including healthcare and a hybrid working model, you’ll play a vital role in ensuring our products not only meet regulatory requirements but also positively impact global health. If you have a strong background in CMC regulatory affairs, a solid understanding of drug development processes, and a passion for compliance and quality, we’d love to have you on board. Join us at GSK and make a difference in the lives of patients around the world!

Frequently Asked Questions (FAQs) for CMC Regulatory Affairs Project Manager Role at GSK
What are the main responsibilities of a CMC Regulatory Affairs Project Manager at GSK?

As a CMC Regulatory Affairs Project Manager at GSK, you'll oversee global CMC regulatory activities for assigned projects. Your duties include developing CMC strategies, preparing submission documents for clinical and marketing applications, and ensuring compliance with global regulatory standards. You will also engage with cross-functional teams to facilitate effective interaction and partnership throughout the project lifecycle.

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What qualifications do I need to apply for the CMC Regulatory Affairs Project Manager position at GSK?

To be a successful candidate for the CMC Regulatory Affairs Project Manager role at GSK, you should have a BSc or equivalent in a relevant scientific discipline, such as chemistry or pharmacy. Experience in CMC Regulatory Affairs or product development and a solid understanding of drug manufacturing processes are essential. A Master’s degree and regulatory certifications are preferred but not mandatory.

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How does GSK support the professional growth of a CMC Regulatory Affairs Project Manager?

GSK believes in fostering a culture of continuous development. As a CMC Regulatory Affairs Project Manager, you will have different opportunities for growth through ongoing training programs, mentorships, and the Performance with Choice initiative, which supports hybrid working. GSK encourages you to expand your skills and stay at the forefront of the evolving regulatory environment.

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What is the work environment like for a CMC Regulatory Affairs Project Manager at GSK?

At GSK, the work environment for a CMC Regulatory Affairs Project Manager is collaborative, inclusive, and innovative. You'll work in cross-functional teams, ensuring that everyone contributes to the regulatory strategies of our products. With a commitment to diversity, equity, and inclusion, you will feel welcome and valued in your role while having the flexibility of a hybrid working model.

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What career progression opportunities exist for CMC Regulatory Affairs Project Managers at GSK?

At GSK, there is a clear pathway for career advancement for CMC Regulatory Affairs Project Managers. With additional experience and professional development, you may move into senior regulatory positions, leadership roles, or even cross-functional positions within other areas of the organization, such as quality or manufacturing.

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Common Interview Questions for CMC Regulatory Affairs Project Manager
Can you describe your experience with CMC regulatory submissions?

When answering this question, highlight your specific involvement in preparing regulatory documents for CMC submissions. Discuss the types of submissions you have managed, such as INDs or NDAs, and the results of your efforts in terms of compliance and timelines.

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How do you stay updated with changing CMC regulatory guidelines?

Discuss your methods for keeping up with regulatory changes, such as attending industry conferences, subscribing to relevant publications, or participating in professional organizations like RAPS. Emphasize your proactive approach to learning and application to ensure compliance.

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Describe a challenge you faced in a previous regulatory project and how you overcame it.

Use the STAR method (Situation, Task, Action, Result) to outline a specific challenge. Focus on the critical thinking and problem-solving skills you used to navigate the issue, and detail the positive outcome that resulted from your actions.

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What strategies would you use to prioritize multiple regulatory projects?

Provide insights into your organizational and time-management skills. Describe your approach to assessing project urgency and regulatory deadlines, and how you communicate effectively with team members to ensure all tasks are aligned with overall goals.

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How do you ensure compliance with global regulatory requirements?

Discuss your understanding of international regulatory frameworks and how you incorporate best practices into your work. Emphasize your attention to detail and your collaborative efforts with teams to ensure all regulatory aspects are met effectively.

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What role does teamwork play in your work as a CMC Regulatory Affairs Project Manager?

Highlight the importance of collaboration in regulatory affairs. Explain how you facilitate communication across different departments, blending expertise to achieve common goals, and fostering a culture of mutual respect and support.

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Can you give an example of how you improved a regulatory process?

Share a specific instance where you took initiative to enhance an existing process. Discuss the tools or strategies you implemented and the impact this had on efficiency and compliance, emphasizing your drive for continuous improvement.

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What qualities do you think are essential for a CMC Regulatory Affairs Project Manager?

State the skills you believe are vital for success in this role, such as strong analytical abilities, attention to detail, effective communication, and adaptability. Use examples from your experience to illustrate these qualities.

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How do you handle tight deadlines in regulatory submissions?

Talk about your strategies for managing stress and staying focused on quality while meeting deadlines. Share your approach to planning ahead and how you leverage teamwork to expedite processes without compromising accuracy.

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What interests you about working at GSK as a CMC Regulatory Affairs Project Manager?

Express your enthusiasm for GSK's mission and values. Highlight how your career ambitions align with GSK’s commitment to innovation and global health, and what unique perspectives you can bring to the team.

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We know that healthy communities depend on healthy people, and healthy communities are the backbone of strong, sustainable societies. As a business, we have responsibilities to society, and society has expectations of us. Our goal is to meet those...

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BENEFITS & PERKS
Dental Insurance
Disability Insurance
Vision Insurance
Flexible Spending Account (FSA)
Health Savings Account (HSA)
Performance Bonus
Family Medical Leave
Paid Holidays
FUNDING
SENIORITY LEVEL REQUIREMENT
TEAM SIZE
EMPLOYMENT TYPE
Full-time, hybrid
DATE POSTED
December 12, 2024

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