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- Tasks: Lead regulatory strategies for product development in the consumer health sector.
- Company: Join a top-tier consumer health business making an impact across EMEA.
- Benefits: Enjoy hybrid work, competitive pay, and opportunities for professional growth.
- Why this job: Be part of a dynamic team driving innovation and compliance in health products.
- Qualifications: Bachelor's degree required; expertise in regulatory affairs for drugs and medical devices preferred.
- Other info: This is a 6-month contract role with potential for future opportunities.
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
Regulatory Consultant employer: Cpl Life Sciences
Contact Detail:
Cpl Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Consultant
✨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 consumer health sector in the EMEA region. This knowledge will not only help you in interviews but also demonstrate your commitment to understanding the role.
✨Tip Number 3
Prepare to discuss your project management skills in detail. Be ready to provide examples of how you've successfully managed regulatory submissions or led cross-functional teams in previous roles, as this is crucial for the position.
✨Tip Number 4
Showcase your ability to develop strong partnerships across various departments. Think of specific instances where you've collaborated with R&D, marketing, or supply chain teams to achieve regulatory objectives, as this will highlight your teamwork skills.
We think you need these skills to ace Regulatory Consultant
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 outlined in the job description.
Highlight Relevant Qualifications: Ensure you mention your relevant Bachelor’s Degree or higher and any additional certifications related to regulatory affairs. This will help establish your credibility and expertise in the field.
Showcase Project Management Skills: In your application, provide examples of your project management experience, especially in relation to regulatory processes. Highlight any successful projects where you led teams or collaborated cross-functionally to achieve regulatory objectives.
How to prepare for a job interview at Cpl Life Sciences
✨Know Your Regulatory Frameworks
Familiarise yourself with the specific regulatory frameworks relevant to the EMEA region, especially those pertaining to drugs, dietary supplements, and medical devices. Be prepared to discuss how these regulations impact product development and compliance.
✨Demonstrate Leadership Skills
As a Regulatory Consultant, you'll be leading a team. Highlight your experience in managing direct reports and collaborating with cross-functional teams. Share examples of how you've successfully guided teams through regulatory challenges.
✨Showcase Your Strategic Thinking
Prepare to discuss how you can provide strategic regulatory input to product development teams. Think about past experiences where your insights led to successful regulatory submissions or improved compliance processes.
✨Be Ready for Scenario Questions
Expect scenario-based questions that assess your problem-solving skills in real-world regulatory situations. Practice articulating your thought process and decision-making strategies when faced with compliance issues or regulatory changes.
