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For Companies At a Glance
- Tasks: Lead regulatory strategies for product development in a dynamic team environment.
- Company: Join a top consumer health business making an impact in the EMEA region.
- Benefits: Enjoy hybrid work options and competitive pay of £75-£85 per hour.
- Why this job: Be part of a collaborative culture that values innovation and operational excellence.
- Qualifications: Bachelor's degree required; expertise in regulatory affairs for drugs, supplements, or medical devices preferred.
- Other info: Opportunity to influence product registrations and work with cross-functional teams.
Reporting to: Senior Manager, CMC EMEA Regulatory Affairs (R&D)
Location: High Wycombe, United Kingdom – Hybrid (2/3 days per week in the office)
Rate: £75- £85 per hour (PAYE/Umbrella)
Cpl Life Sciences are collaborating with a leading consumer health business who are looking for a Regulatory CMC Consultant on a 6-month basis.
Responsible for the development of CMC/technical regulatory strategies across the EMEA region providing regulatory input and technical guidance on regional regulatory requirements to product development teams within the Self Care franchise.
Leads a Regulatory Affairs team ensuring the success of new product registrations, line extensions and new indications and claims with supportive technical justification/documentation in alignment with the business plan.
Create an environment of operational excellence through regulatory expertise by managing direct reports and collaborating with cross-functional teams to successfully achieve regulatory objectives.
Manages the global &/or regional regulatory deliverables for drugs, dietary supplements & medical devices as relevant, within their brand area & geographic responsibility.
Develops strong partnerships with Regulatory Affairs Franchise, R&D, Marketing, Supply Chain and local business representatives.
Represents the Regulatory Affairs CMC function as appropriate in Self Care Franchise, functional and business Leadership teams.
Provides strategic regulatory input and technical guidance on regional regulatory requirements to product development teams.
Supports the business initiatives, by strengthening propositions, influence and acts as strategic advisor on brand/need state portfolio forums.
Participates in cross-functional project teams to define development program requirements and risks.
Prepares and submits regulatory submissions according to applicable regulatory requirements and guidelines in EMEA.
Regulatory Compliance
Maintains awareness of current regulations and anticipate implications and opportunities because of changes to the relevant regulatory environments.
Ensure that all products comply with local regulatory and quality system requirements.
Ensures quality and compliance in all actions.
Participate in the development and implementation of, and maintains compliance with, all applicable Processes, SOPs and working instructions.
Ensures that the enterprise Regulatory systems are accurate and fully maintained.
Ensure any compliance issues are reviewed and escalated and relevant corrective/preventative actions are implemented locally.
Identifies and/or implements regional process improvement opportunities and ensures implementation of relevant global or regional regulatory initiatives.
Evaluates deliverables of self/direct reports against set timelines, acting where necessary to minimize delays and anticipate difficulties/risks.
Partners with the business to deliver regulatory outcomes to enable committed business plans within area of responsibility.
Qualifications
- Relevant Bachelor's Degree or higher
- Expertise across a broad spectrum of Regulatory classifications including Drugs, Dietary Supplement and/or Medical Devices, mainly pharmaceutical CMC regulatory affairs
- Knowledge of regulatory frameworks and external environments in the EU and wider EMEA, and the ability to apply these to regulatory solutions throughout the product lifecycle.
- Solid understanding of regulatory CMC in the markets of relevance
- Strong project management skills.
- Proficiency in English
Consultant Support employer: Cpl Life Sciences
Contact Detail:
Cpl Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Consultant Support
✨Tip Number 1
Network with professionals in the regulatory affairs field, especially those who have experience in CMC. Attend industry events or webinars to connect with potential colleagues and learn about the latest trends and challenges in the EMEA region.
✨Tip Number 2
Familiarise yourself with the specific regulatory frameworks and guidelines relevant to the EMEA region. This knowledge will not only help you in interviews but also demonstrate your commitment to understanding the role's requirements.
✨Tip Number 3
Prepare to discuss your project management skills in detail. Be ready to share examples of how you've successfully managed regulatory projects, highlighting your ability to meet deadlines and navigate complex regulatory environments.
✨Tip Number 4
Showcase your ability to collaborate with cross-functional teams. Think of instances where you've worked with R&D, marketing, or supply chain teams to achieve regulatory objectives, as this is a key aspect of the Consultant Support role.
We think you need these skills to ace Consultant Support
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in regulatory affairs, particularly in CMC and EMEA regulations. Use specific examples that demonstrate your expertise in managing regulatory submissions and compliance.
Craft a Compelling Cover Letter: Write a cover letter that clearly outlines your motivation for applying to this role. Emphasise your understanding of the regulatory landscape in the EMEA region and how your skills align with the responsibilities of the Consultant Support position.
Highlight Relevant Skills: In your application, focus on key skills such as project management, regulatory compliance, and your ability to work collaboratively with cross-functional teams. Provide concrete examples of how you've successfully navigated regulatory challenges in the past.
Proofread Your Application: Before submitting, carefully proofread your application for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial in regulatory affairs.
How to prepare for a job interview at Cpl Life Sciences
✨Know Your Regulatory Frameworks
Familiarise yourself with the regulatory frameworks in the EU and EMEA regions. Be prepared to discuss how these regulations impact product development and compliance, as this role heavily relies on understanding these environments.
✨Demonstrate Project Management Skills
Highlight your project management experience during the interview. Discuss specific examples where you successfully managed timelines and deliverables, especially in a regulatory context, to show that you can handle the responsibilities of this role.
✨Showcase Your Team Leadership Experience
Since the role involves leading a Regulatory Affairs team, be ready to share your experiences in managing teams. Talk about how you've fostered collaboration and operational excellence in previous roles, as this will be crucial for success.
✨Prepare for Technical Questions
Expect technical questions related to CMC regulatory affairs, including submissions and compliance issues. Brush up on your knowledge of relevant processes and be ready to provide insights into how you've navigated similar challenges in the past.
