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- Tasks: Lead operational readiness for new product launches in a dynamic pharmaceutical environment.
- Company: Join a leading pharmaceutical company focused on innovative product development.
- Benefits: Enjoy a 6-month contract with potential for growth and collaboration across teams.
- Why this job: Be part of impactful projects that shape the future of healthcare and improve lives.
- Qualifications: Experience in project management, regulatory submissions, and strong knowledge of cGMP and FDA regulations required.
- Other info: Work with multidisciplinary teams and gain exposure to global regulatory perspectives.
The predicted salary is between 48000 - 72000 £ per year.
We are looking for an experienced project manager to join a large pharmaceutical company on an initial 6-month contract. This position is accountable for ensuring comprehensive operational preparedness ahead of the commercial launch of a new product. You will oversee and integrate all New Product Introduction (NPI) efforts, including launch execution, readiness planning, and development of product and process strategies, in collaboration with cross-functional teams at both the site level and corporate functions.
Key Responsibilities:
- Lead all operational readiness efforts related to NPI (process and analytical), working with multidisciplinary teams across Manufacturing, Engineering, Quality, MSAT, Supply Chain, and CMC.
- Manage and coordinate regulatory submissions and inspection readiness activities, including Pre-Approval Inspections (PAI).
- Proactively identify potential risks associated with new product launches and develop strong mitigation strategies to support successful Process Performance Qualification (PPQ) and ensure stable, compliant commercial production.
Technical Expertise Required:
- Strong working knowledge of cGMP, FDA regulations, and international pharmaceutical manufacturing and quality standards.
- Proven experience applying Process Analytical Technology (PAT), ASTM standards, and 21st Century cGMP principles.
- Familiarity with ICH Q8, Q9, Q10, and Q11, and their application in a regulated environment.
- Experience with CMC and regulatory submission processes, including NDAs and MAAs.
- Understanding of differing global regulatory perspectives on Quality by Design (QbD) and their impact on regulatory strategy and submissions.
- Broad knowledge of regulatory compliance, validation, and inspection readiness.
- In-depth understanding of product development lifecycles, cross-functional development teams, and project governance processes.
Senior Project Manager employer: Blackfield Associates
Contact Detail:
Blackfield Associates Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Project Manager
✨Tip Number 1
Network with professionals in the pharmaceutical industry, especially those who have experience in project management roles. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends in NPI and regulatory compliance.
✨Tip Number 2
Familiarise yourself with the specific cGMP and FDA regulations relevant to the role. Consider joining online forums or groups where you can discuss these topics with others in the field, which can help you stay updated and demonstrate your commitment during interviews.
✨Tip Number 3
Prepare to discuss your previous experiences with cross-functional teams and how you've successfully managed projects in a regulated environment. Use specific examples that highlight your ability to lead operational readiness efforts and mitigate risks.
✨Tip Number 4
Research the company’s recent product launches and any challenges they faced. This knowledge will not only help you tailor your discussions but also show your genuine interest in their operations and your proactive approach to problem-solving.
We think you need these skills to ace Senior Project Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in project management, particularly in the pharmaceutical sector. Emphasise your familiarity with cGMP, FDA regulations, and any specific projects that demonstrate your ability to lead operational readiness efforts.
Craft a Compelling Cover Letter: In your cover letter, address how your skills align with the key responsibilities outlined in the job description. Mention your experience with cross-functional teams and your approach to risk management in new product launches.
Showcase Technical Expertise: Clearly outline your technical expertise related to Process Analytical Technology (PAT) and regulatory submission processes. Use specific examples to illustrate your understanding of ICH guidelines and Quality by Design principles.
Proofread and Edit: Before submitting your application, thoroughly proofread your documents for any grammatical errors or typos. A polished application reflects your attention to detail, which is crucial for a Senior Project Manager role.
How to prepare for a job interview at Blackfield Associates
✨Showcase Your Project Management Experience
Be prepared to discuss your previous project management roles in detail. Highlight specific projects where you led cross-functional teams, particularly in the pharmaceutical sector, and how you ensured operational readiness for product launches.
✨Demonstrate Technical Knowledge
Familiarise yourself with cGMP, FDA regulations, and the specific technical expertise required for the role. Be ready to explain how you've applied Process Analytical Technology (PAT) and other relevant standards in your past work.
✨Prepare for Risk Management Questions
Anticipate questions about risk identification and mitigation strategies. Think of examples where you successfully navigated potential risks during a product launch and how you developed effective solutions.
✨Understand Regulatory Submission Processes
Brush up on your knowledge of CMC and regulatory submission processes, including NDAs and MAAs. Be prepared to discuss your experience with these processes and how they relate to ensuring compliance and successful product launches.
