At a Glance
- Tasks: Lead global regulatory CMC strategies and ensure compliance across product lifecycles.
- Company: Accede Solutions Inc. is a dynamic company focused on innovative regulatory solutions.
- Benefits: Enjoy full remote flexibility, competitive salary, comprehensive healthcare, and paid time off.
- Why this job: Make a measurable impact in a fast-paced environment while collaborating with diverse teams.
- Qualifications: Bachelor's degree in a scientific field; 6+ years in pharma, with CMC regulatory experience preferred.
- Other info: Join a culture of mentorship and professional development in a collaborative setting.
The predicted salary is between 36000 - 60000 Β£ per year.
Manager Regulatory CMC Strategy (Remote – Anywhere)
Manager Regulatory CMC Strategy (Remote – Anywhere)
This position is posted by Jobgether on behalf of Accede Solutions Inc. We are currently looking for a Manager Regulatory CMC Strategy in Anywhere.
Join a dynamic and collaborative environment where you will play a key role in shaping global regulatory CMC strategies across the product lifecycle. This position involves preparing high-quality regulatory submissions, collaborating with cross-functional teams, and ensuring regulatory compliance across multiple regions. It is ideal for a scientifically driven professional who thrives in a fast-paced, deadline-oriented setting, with the opportunity to make a measurable impact on global product success.
Accountabilities:
- Develop and execute regulatory CMC strategies aligned with global requirements for submissions, approvals, and lifecycle management
- Lead resolution of complex issues, enabling informed decision-making in partnership with internal and external stakeholders
- Collaborate with R&D, Quality, and Regulatory Affairs teams to align on submission content and timelines
- Author and review regulatory CMC submissions including new registrations, variations, renewals, and responses to agency queries
- Ensure accuracy and regulatory compliance of technical documentation and drive timely fulfillment of CMC-related commitments
- Represent CMC on project teams, oversee project execution, and manage assigned regulatory portfolios with minimal supervision
- Mentor junior team members and contribute to broader regulatory or organizational initiatives as needed
Requirements
- Bachelor\’s degree in a scientific discipline (minimum); an advanced degree (MS, PhD, PharmD) is preferred
- At least 6 years of pharmaceutical industry experience, including a minimum of 2 years in CMC regulatory authoring
- Solid understanding of pharmaceutical development, manufacturing processes, and cGMP compliance
- Experience with lifecycle management, global regulatory submissions, and post-approval change management
- Strong verbal and written communication skills; comfortable interacting with diverse technical and regulatory audiences
- Proficiency in Microsoft Office and regulatory documentation systems (e.g., Documentum)
Benefits
- Competitive salary based on experience and qualifications
- Full remote flexibility, allowing you to work from anywhere
- Comprehensive healthcare coverage including medical, dental, and vision
- Paid time off and holidays
- Opportunities for continued professional development and mentorship
- Collaborative and inclusive work culture
Jobgether is a Talent Matching Platform that partners with companies worldwide to efficiently connect top talent with the right opportunities through AI-driven job matching.
When you apply, your profile goes through our AI-powered screening process designed to identify top talent efficiently and fairly.
Our AI evaluates your CV and LinkedIn profile thoroughly, analyzing your skills, experience and achievements.
It compares your profile to the job\’s core requirements and past success factors to determine your match score.
Based on this analysis, we automatically shortlist the 3 candidates with the highest match to the role.
When necessary, our human team may perform an additional manual review to ensure no strong profile is missed.
The process is transparent, skills-based, and free of bias β focusing solely on your fit for the role. Once the shortlist is completed, we share it directly with the company that owns the job opening. The final decision and next steps (such as interviews or additional assessments) are then made by their internal hiring team.
Thank you for your interest!
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Manager Regulatory CMC Strategy (Remote - Anywhere) employer: Jobgether
Contact Detail:
Jobgether Recruiting Team
StudySmarter Expert Advice π€«
We think this is how you could land Manager Regulatory CMC Strategy (Remote - Anywhere)
β¨Tip Number 1
Familiarise yourself with the latest global regulatory guidelines and CMC strategies. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in a fast-evolving field.
β¨Tip Number 2
Network with professionals in the pharmaceutical industry, especially those involved in regulatory affairs. Engaging in discussions or attending relevant webinars can provide insights and potentially lead to referrals.
β¨Tip Number 3
Prepare to discuss specific examples of how you've successfully navigated complex regulatory challenges in your previous roles. Highlighting your problem-solving skills will set you apart from other candidates.
β¨Tip Number 4
Showcase your ability to collaborate with cross-functional teams by preparing anecdotes that illustrate your teamwork skills. This is crucial for the role, as it involves working closely with R&D and Quality teams.
We think you need these skills to ace Manager Regulatory CMC Strategy (Remote - Anywhere)
Some tips for your application π«‘
Tailor Your CV: Make sure to customise your CV to highlight relevant experience in regulatory CMC strategy. Emphasise your pharmaceutical industry experience, particularly in CMC regulatory authoring and lifecycle management.
Craft a Compelling Cover Letter: Write a cover letter that showcases your understanding of the role and how your skills align with the company's needs. Mention specific examples of past experiences where you successfully developed regulatory strategies or resolved complex issues.
Highlight Communication Skills: Since strong verbal and written communication skills are essential for this role, provide examples in your application that demonstrate your ability to interact with diverse technical and regulatory audiences effectively.
Showcase Team Collaboration: Illustrate your experience working collaboratively with cross-functional teams such as R&D, Quality, and Regulatory Affairs. Highlight any leadership roles or mentoring experiences that showcase your ability to guide junior team members.
How to prepare for a job interview at Jobgether
β¨Understand Regulatory CMC Fundamentals
Make sure you have a solid grasp of regulatory CMC strategies and lifecycle management. Brush up on your knowledge of pharmaceutical development and manufacturing processes, as this will be crucial in demonstrating your expertise during the interview.
β¨Prepare for Scenario-Based Questions
Expect to face scenario-based questions that assess your problem-solving skills and decision-making abilities. Think of examples from your past experience where you successfully resolved complex issues or collaborated with cross-functional teams.
β¨Showcase Your Communication Skills
Since the role involves interacting with diverse technical and regulatory audiences, practice articulating your thoughts clearly and concisely. Be prepared to discuss how you've effectively communicated complex information in previous roles.
β¨Highlight Mentorship Experience
If you have experience mentoring junior team members, be sure to mention it. This shows your leadership potential and willingness to contribute to the team's growth, which is an important aspect of the role.