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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 options and competitive pay of £75-£85 per hour.
- 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: Collaborate with cross-functional teams and manage direct reports for operational excellence.
Reporting to: Senior Manager, CMC
Functional group: 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.
The Roles & Responsibilities include:
- 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.
- Maintains awareness of current regulations and anticipate implications and opportunities because of changes to the relevant regulatory environments.
- Communicates changes to appropriate management and cross functional experts as appropriate.
- 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.
Team Management:
- Evaluates deliverables of self/direct reports against set timelines, acting where necessary to minimize delays and anticipate difficulties/risks.
Specific requirements:
- Partners with the business to deliver regulatory outcomes to enable committed business plans within area of responsibility.
Job Requirements:
- 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.
For more information, please reach out to me at lucy.kirkaldy@cpl.com.
Regulatory CMC Consultant employer: Cpl Life Sciences
Contact Detail:
Cpl Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory CMC Consultant
✨Tip Number 1
Familiarise yourself with the latest regulatory frameworks in the EMEA region. Understanding the nuances of CMC regulations will not only help you in interviews but also demonstrate your commitment to staying updated in this fast-evolving field.
✨Tip Number 2
Network with professionals in the regulatory affairs sector, especially those who have experience in CMC. Engaging with industry experts can provide insights into the role and may even lead to referrals or recommendations.
✨Tip Number 3
Prepare to discuss specific examples of how you've successfully navigated regulatory challenges in past roles. Highlighting your problem-solving skills and project management experience will set you apart from other candidates.
✨Tip Number 4
Showcase your ability to collaborate with cross-functional teams. This role requires strong partnerships across various departments, so be ready to share experiences where you've effectively worked with others to achieve regulatory objectives.
We think you need these skills to ace Regulatory CMC Consultant
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in regulatory affairs, particularly in CMC for drugs, dietary supplements, and medical devices. Use keywords from the job description to demonstrate your fit for the role.
Craft a Compelling Cover Letter: Write a cover letter that showcases your understanding of the regulatory landscape in the EMEA region. Mention specific examples of how you've successfully navigated regulatory challenges in previous roles.
Highlight Team Management Experience: Since the role involves managing a team, emphasise any leadership or project management experience you have. Provide examples of how you've evaluated deliverables and minimised delays in past projects.
Showcase Regulatory Knowledge: Demonstrate your knowledge of current regulations and compliance requirements in your application. Discuss how you've kept up-to-date with changes in the regulatory environment and how you've applied this knowledge in your work.
How to prepare for a job interview at Cpl Life Sciences
✨Know Your Regulatory Frameworks
Make sure you have a solid understanding of the regulatory frameworks in the EU and EMEA. Be prepared to discuss how these regulations impact product development and compliance, as this will show your expertise in CMC regulatory affairs.
✨Demonstrate Project Management Skills
Highlight your project management experience during the interview. Discuss specific projects where you successfully managed timelines and deliverables, as this role requires strong organisational skills to navigate complex regulatory processes.
✨Showcase Cross-Functional Collaboration
Prepare examples of how you've worked with cross-functional teams in the past. This role involves collaborating with various departments, so demonstrating your ability to build partnerships and communicate effectively will be crucial.
✨Stay Updated on Regulatory Changes
Be ready to discuss recent changes in regulatory requirements and how they might affect the industry. Showing that you are proactive about staying informed will demonstrate your commitment to regulatory excellence and operational success.
