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For Companies At a Glance
- Tasks: Lead regulatory strategies for innovative medicines and ensure compliance across Europe.
- Company: Join AbbVie, a leader in healthcare dedicated to transforming lives through innovative solutions.
- Benefits: Enjoy a full-time role with opportunities for growth and collaboration in a dynamic environment.
- Why this job: Make a real impact on health while working with diverse teams in a culture of innovation.
- Qualifications: A degree in life sciences and experience in pharmaceutical regulatory affairs are essential.
- Other info: AbbVie values diversity and is committed to equal opportunity for all applicants.
The predicted salary is between 36000 - 60000 £ per year.
Overview
In collaboration with line manager and/or Area Product Lead, is responsible for implementation of registration strategy to ensure the regulatory approval of commercially successful pharma products in the Europe region. Is responsible for ensuring effective product maintenance and lifecycle management, in line with legal/regulatory requirements and regional business needs. May also support European regulatory strategy for assets in development.
Responsibilities
- Provides clear and constructive Europe Region (Area) regulatory input and intelligence to Area and Global Regulatory & Development Project Teams via the Area and/or Global Regulatory Lead (GRL) in accordance with Area & Commercial objectives.
- Ensure planned drug development activities comply with Area guidelines and if they do not provide a critical analysis of the risks and issues with a remediation proposal.
- Support global product development strategy(s); outlining options for Scientific Advice/PIP/IMPD, coordinating preparation of briefing packages and co-ordinating and leading agency meeting preparation.
- Prepare strategy recommendations to global regulatory and development teams in order to shape the global product strategy in line with Area regulatory and commercial objectives
- Define & implement Area filing strategy (including CP, MRP, DCP); identifying risks and proposing mitigation.
- Lead, plan, conduct and implement regulatory activities in support of lifecycle maintenance in Area. Identify compliance risks and remediation activities proactively.
- GRPT & ARPT representative ensuring regulatory requirements/interests of Area & Affiliate are represented at GRPT
- Supports co-ordination of the review of CMC, QRD, PSUR and labelling submissions and approval of product-related packaging as required to ensure regulatory compliance.
- Interface with EMA or Area Health Authority(s) for products within the Therapeutic Area on behalf of the Product Lead when required.
- Responsible for ensuring effective planning and tracking of activities, especially submissions and key correspondence. Ensures effective planning and tracking of activities via internal tools.
- Establishes strong and effective relationships with affiliates, area and global regulatory teams as well as cross-functional teams thereby ensuring RA activities are in line with regional business priorities.
- Potential to mentor less experienced Area regulatory colleagues as required
Processes
- Follows Global Regulatory policies and procedures.
- Ensures that new processes are developed and implemented in order to leverage the global infrastructure and maximise efficiency, ensures that new processes are aligned with global policies, but also meet regional regulations and needs.
- Responsible for the Notification of Regulatory activities and RIM system entry/data accuracy for allocated projects.
- Responsible for ensuring forecasts are developed and actuals managed in line with regional requirements and communicating these to Area TA Head, GRL and R&D finance for assigned projects.
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Regulatory Affairs Manager employer: AbbVie
Contact Detail:
AbbVie Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Manager
✨Tip Number 1
Familiarise yourself with the specific regulatory frameworks and guidelines relevant to the UK and EU. Understanding the nuances of these regulations will not only help you in interviews but also demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have experience with AbbVie or similar companies. Engaging with industry groups on platforms like LinkedIn can provide valuable insights and potentially lead to referrals.
✨Tip Number 3
Stay updated on recent developments in pharmaceutical regulations and any changes that may impact the industry. This knowledge can be a great conversation starter during interviews and shows your proactive approach to staying informed.
✨Tip Number 4
Prepare to discuss your previous experiences in regulatory affairs, particularly any successful projects or challenges you've overcome. Highlighting your problem-solving skills and ability to work collaboratively will resonate well with the hiring team.
We think you need these skills to ace Regulatory Affairs Manager
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and qualifications required for the Regulatory Affairs Manager position at AbbVie. Tailor your application to highlight how your experience aligns with their needs.
Highlight Relevant Experience: In your CV and cover letter, emphasise your previous experience in pharmaceutical regulatory affairs, particularly any work related to EU and non-EU regulations. Use specific examples to demonstrate your expertise in managing regulatory submissions and compliance.
Showcase Communication Skills: Since excellent communication skills are essential for this role, ensure that your application reflects your ability to communicate complex regulatory information clearly. Consider including examples of successful negotiations or presentations you've conducted.
Tailor Your Cover Letter: Craft a personalised cover letter that addresses AbbVie's mission and values. Explain why you are passionate about contributing to their goals in innovative medicine and how your skills can help them achieve their objectives.
How to prepare for a job interview at AbbVie
✨Know Your Regulations
Familiarise yourself with the specific pharmaceutical regulations and guidelines relevant to the role. AbbVie operates in a complex regulatory environment, so demonstrating your knowledge of both EU and non-EU regulations will show that you are prepared for the challenges of the position.
✨Showcase Your Experience
Be ready to discuss your previous experience in Regulatory Affairs, particularly any involvement with regulatory procedures like CP, DCP, or MRP. Highlight specific projects where you successfully navigated regulatory challenges, as this will illustrate your capability to handle the responsibilities of the role.
✨Demonstrate Leadership Skills
As a Regulatory Affairs Manager, you'll need to lead and support teams effectively. Prepare examples of how you've influenced others and managed cross-functional teams in the past. This will help convey your ability to work collaboratively and drive results within a matrixed environment.
✨Prepare for Scenario Questions
Expect scenario-based questions that assess your problem-solving skills and ability to manage multiple projects. Think about potential regulatory issues that could arise and how you would address them. This preparation will demonstrate your strategic thinking and readiness to tackle real-world challenges.
