Senior Regulatory Manager

Senior Regulatory Manager

Full-Time 43200 - 72000 £ / year (est.) No home office possible
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At a Glance

  • Tasks: Lead regulatory strategies and manage submissions for innovative pharmaceutical products.
  • Company: Join a global biotech leader dedicated to improving lives through groundbreaking medical solutions.
  • Benefits: Enjoy a 12-month contract with potential for remote work and industry-leading perks.
  • Why this job: Be part of a mission-driven team making a real impact on health and wellness worldwide.
  • Qualifications: Experience in regulatory affairs and a strong understanding of CMC requirements are essential.
  • Other info: This role offers the chance to work on high-impact projects in a dynamic environment.

The predicted salary is between 43200 - 72000 £ per year.

Senior Regulatory Manager – Pharmaceuticals – 12-Month Contract

Our client, a globally recognised pioneer in Biotechnology, are recruiting for the position of Senior Regulatory Manager. A leader in the industry, our client focuses on areas of high unmet medical need and leverages its expertise to stride for solutions. This is your chance to join them on their global mission to better the lives of those effected by disease and illness.

Responsibilities:

  • Responsible for the generation of country specific regulatory strategies and providing feedback to internal teams regarding submission plans and execution of the strategy for two or more products.
  • Interfaces with the affiliate offices for specific strategies or activities that impact a specific country.
  • Ensuring CMC regional issues impacting global regulatory strategy for proposed CMC filings are considered and risks identified with appropriate contingency strategies
  • Review the preparation of M2 and 3 CMC components of filings and assess fitness of purpose for submission in the relevant countries
  • Manages strategy and execution for all regulatory CMC submissions (e.g. late stage clinical trials, variations, extensions and marketing applications) for products within the portfolio in compliance with global filing plans and local regulatory requirements with minimal supervision.
  • Authoring and coordinating responses to questions across assigned products and countries.
  • Communicate regional needs for ensuring reliability of the supply chain and successful launch are well defined and implemented in collaboration with relevant regional stakeholders
  • Provides guidance for regulatory assessments of change control request.
  • Sets project time frames and priorities for products under their responsibility based on project objectives and ongoing assignments; raises resource constraints
  • Gathering, consolidating and analysing regulatory intelligence for International Markets and supports its application to product-specific activities
  • Share regulatory information and implications with the stakeholders on an ongoing basis and provide advice on regional considerations
  • Maintain an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to the companies products.
  • If this role is of interest to you, please apply now!

    #LI-KT1

    Senior Regulatory Manager employer: Quanta part of QCS Staffing

    Join a globally recognised pioneer in Biotechnology as a Senior Regulatory Manager, where you will play a crucial role in shaping regulatory strategies that directly impact the lives of patients. Our company fosters a collaborative and innovative work culture, offering extensive opportunities for professional growth and development, all while being part of a mission-driven team dedicated to addressing high unmet medical needs. Located in a vibrant area, we provide a supportive environment that values your contributions and encourages continuous learning.
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    Contact Detail:

    Quanta part of QCS Staffing Recruiting Team

    StudySmarter Expert Advice 🤫

    We think this is how you could land Senior Regulatory Manager

    ✨Tip Number 1

    Network with professionals in the biotechnology and pharmaceuticals sectors. Attend industry conferences or webinars where you can meet people who work in regulatory affairs. This can help you gain insights into the role and potentially get a referral.

    ✨Tip Number 2

    Stay updated on the latest regulatory changes and trends in the pharmaceutical industry. Follow relevant publications, blogs, and social media channels to demonstrate your knowledge during interviews and discussions.

    ✨Tip Number 3

    Prepare to discuss specific regulatory strategies you've implemented in previous roles. Be ready to share examples of how you've navigated complex regulatory environments and the outcomes of your efforts.

    ✨Tip Number 4

    Familiarise yourself with the company's products and their regulatory history. Understanding their portfolio will allow you to tailor your conversations and show genuine interest in their mission and challenges.

    We think you need these skills to ace Senior Regulatory Manager

    Regulatory Affairs Expertise
    Pharmaceutical Knowledge
    CMC (Chemistry, Manufacturing, and Controls) Understanding
    Strategic Planning
    Risk Management
    Project Management
    Communication Skills
    Stakeholder Engagement
    Regulatory Intelligence Analysis
    Submission Preparation
    Change Control Assessment
    Attention to Detail
    Problem-Solving Skills
    Adaptability to Regulatory Changes

    Some tips for your application 🫡

    Tailor Your CV: Make sure your CV highlights relevant experience in regulatory affairs, particularly in the pharmaceutical or biotechnology sectors. Emphasise your achievements in managing regulatory submissions and strategies.

    Craft a Compelling Cover Letter: Write a cover letter that specifically addresses the responsibilities mentioned in the job description. Explain how your background aligns with their needs, particularly your experience with CMC submissions and regulatory strategy.

    Showcase Your Knowledge: Demonstrate your understanding of current regulatory policies and legislation in your application. Mention any specific regulations or guidelines you are familiar with that are relevant to the role.

    Highlight Collaboration Skills: Since the role involves interfacing with various teams and stakeholders, include examples of successful collaboration in your application. This could be through project management or cross-functional teamwork.

    How to prepare for a job interview at Quanta part of QCS Staffing

    ✨Understand Regulatory Frameworks

    Familiarise yourself with the specific regulatory frameworks relevant to the pharmaceutical industry. Be prepared to discuss how these regulations impact product submissions and strategies, as this will demonstrate your expertise in the field.

    ✨Showcase Your Strategic Thinking

    Prepare examples of how you've developed and executed regulatory strategies in previous roles. Highlight your ability to identify risks and create contingency plans, as this is crucial for the Senior Regulatory Manager position.

    ✨Communicate Effectively

    Since the role involves interfacing with various teams and stakeholders, practice articulating complex regulatory concepts clearly and concisely. This will help you convey your ideas effectively during the interview.

    ✨Stay Updated on Industry Trends

    Demonstrate your commitment to the field by discussing recent developments in regulatory policies and legislation. Showing that you are proactive about staying informed will impress your interviewers and reflect your dedication to the role.

    Senior Regulatory Manager
    Quanta part of QCS Staffing
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