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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 valuable industry experience.
- Why this job: Be part of a mission-driven team making a real impact in healthcare.
- Qualifications: Experience in project management, regulatory submissions, and pharmaceutical manufacturing is essential.
- Other info: Collaborate with diverse teams and enhance your skills in a fast-paced setting.
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.
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, as this will help you stay updated and demonstrate your commitment to compliance.
✨Tip Number 3
Prepare to discuss your experience with cross-functional teams during interviews. Think of specific examples where you successfully led projects involving multiple departments, as this will showcase your ability to integrate efforts and manage diverse stakeholders effectively.
✨Tip Number 4
Research the company’s recent product launches and any challenges they faced. This knowledge will not only help you tailor your responses during interviews 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, clearly articulate your understanding of New Product Introduction (NPI) processes and how your skills align with the responsibilities outlined in the job description. Use specific examples from your past experiences to showcase your expertise in managing cross-functional teams.
Highlight Technical Expertise: Ensure you detail your technical knowledge related to Process Analytical Technology (PAT), regulatory submissions, and compliance standards. Mention any relevant certifications or training that support your qualifications for this role.
Proofread and Edit: Before submitting your application, take the time to proofread your documents. Check for grammatical errors, clarity, and ensure that all information is accurate. A polished application reflects your attention to detail, which is crucial for a Senior Project Manager.
How to prepare for a job interview at Blackfield Associates
✨Showcase Your Project Management Experience
Be prepared to discuss your previous project management roles, especially those related to new product introductions in the pharmaceutical sector. Highlight specific examples where you led cross-functional teams and successfully managed operational readiness for product launches.
✨Demonstrate Technical Knowledge
Familiarise yourself with cGMP, FDA regulations, and international standards relevant to the role. Be ready to explain how you've applied these principles in past projects, particularly in relation to Process Analytical Technology (PAT) and regulatory submissions.
✨Prepare for Risk Management Questions
Anticipate questions about risk identification and mitigation strategies. Think of instances where you proactively addressed potential risks during a product launch and be ready to discuss the outcomes of your strategies.
✨Understand Regulatory Compliance
Brush up on your knowledge of regulatory compliance and inspection readiness. Be prepared to discuss your experience with regulatory submissions, including NDAs and MAAs, and how you navigated different global regulatory perspectives.
