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- Tasks: Lead regulatory strategies for 1-3 products across APAC, MART CEER, and LatAm.
- Company: Join a diverse team at Randstad CPE, promoting equality and innovation in the pharmaceutical industry.
- Benefits: Enjoy a flexible work schedule with remote options and a supportive work environment.
- Why this job: Make a real impact on global health while collaborating with cross-functional teams.
- Qualifications: BA/BS required; 3-5+ years in pharma/biotech, especially in International/Regulatory Emerging Markets.
- Other info: This is a 12-month contract role, ideally 2 days in the office.
The predicted salary is between 43200 - 72000 £ per year.
Are you an experienced Senior Regulatory Affairs Manager? Do you have experience in the International Growth Markets? If so, we would love to hear from you!
The successful candidate will become a member of the Global Regulatory Project team representing the international Growth markets with accountability for 1-3 marketed products across APAC, MART CEER and LatAm. You will be developing and implementing regulatory strategies to support product lifecycle management, ensuring compliance with evolving global requirements. You will also provide strategic regulatory guidance to project teams and ensure availability of current regulatory documentation to support new submission and lifecycle management activities across all regions.
This is a contract position, offered initially for 12 months, working 37.5 hours per week. (Preferably 2 days a week in the office / Inside IR35).
Responsibilities:- Manages the communication, development, and execution of International Growth Market strategies for Safety Updates and lifecycle management (LCM) submissions across multiple regions for 1-3 products.
- Ensure effective cross-functional collaboration by leading and participating in regular meetings to facilitate the collaborative exchange of key project information and strategic alignment.
- Accountable for the development and execution of lifecycle management submissions packages across all IGM regions, ensuring compliance and strategic alignment.
- Collaborate closely with cross functional teams such as partners, affiliate counterparts, Artwork teams, and PV to establish optimal strategies that maintain supply continuity and prioritise patient safety.
- Ensure timely delivery of agreed regulatory strategies, meeting established deadlines and regulatory expectations.
- Oversee CRO activities to guarantee the efficient and timely preparation of submission packages, maintaining high-quality regulatory standards.
- BA/BS/University degree required - Life/Health Sciences preferred.
- Minimum 3-5+ years pharmaceutical/biotechnology industry experience in International/Regulatory Emerging Markets.
- Skills and experience to represent the IGM group on project teams.
- Experience and knowledge in the preparation of lifecycle management submissions.
- Good knowledge and understanding of applicable regions.
Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.
Candidates must be eligible to live and work in the UK.
For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.
Contact Detail:
Randstad Technologies Recruitment Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Regulatory Affairs Manager
✨Tip Number 1
Familiarise yourself with the specific regulatory requirements for the APAC, MART CEER, and LatAm regions. Understanding the nuances of these markets will not only enhance your knowledge but also demonstrate your commitment to the role during discussions.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have experience in international growth markets. Engaging in conversations can provide insights into current trends and challenges, which you can reference in your interactions with us.
✨Tip Number 3
Prepare to discuss your previous experiences with lifecycle management submissions in detail. Be ready to share specific examples of how you've successfully navigated regulatory challenges, as this will showcase your expertise and problem-solving skills.
✨Tip Number 4
Stay updated on the latest developments in global regulatory standards and compliance. Being knowledgeable about recent changes will allow you to contribute meaningfully to strategic discussions and show that you're proactive about your professional development.
We think you need these skills to ace Senior Regulatory Affairs Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in regulatory affairs, particularly in International Growth Markets. Emphasise your achievements in lifecycle management submissions and any relevant cross-functional collaboration.
Craft a Compelling Cover Letter: Write a cover letter that specifically addresses the job description. Mention your experience with marketed products across APAC, MART CEER, and LatAm, and how you can contribute to the company's regulatory strategies.
Highlight Relevant Skills: In your application, clearly outline your skills related to regulatory compliance, project management, and communication. Provide examples of how you've successfully managed regulatory strategies in previous roles.
Proofread Your Application: Before submitting, carefully proofread your application for any errors or inconsistencies. A well-presented application reflects your attention to detail, which is crucial in regulatory affairs.
How to prepare for a job interview at Randstad Technologies Recruitment
✨Showcase Your Regulatory Expertise
Make sure to highlight your experience in regulatory affairs, especially within the International Growth Markets. Be prepared to discuss specific examples of how you've developed and implemented regulatory strategies for product lifecycle management.
✨Demonstrate Cross-Functional Collaboration
Since the role requires effective collaboration with various teams, come ready to share instances where you've successfully led or participated in cross-functional projects. Emphasise your ability to facilitate communication and strategic alignment among diverse groups.
✨Prepare for Lifecycle Management Discussions
Familiarise yourself with lifecycle management submissions and be ready to discuss your knowledge and experience in this area. Consider preparing a brief overview of a successful submission you managed, including challenges faced and how you overcame them.
✨Understand Global Regulatory Requirements
Research the evolving global regulatory landscape relevant to the regions mentioned in the job description. Being able to articulate your understanding of these requirements will demonstrate your readiness to ensure compliance and support the company's objectives.
