At a Glance
- Tasks: Lead regulatory strategies for innovative neuroscience products across Europe.
- Company: Join AbbVie, a leader in transforming lives through innovation.
- Benefits: Competitive salary, inclusive culture, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on integrity and community service.
- Why this job: Make a real impact in healthcare by shaping regulatory pathways for groundbreaking therapies.
- Qualifications: Degree in life sciences and experience in European regulatory strategy required.
The predicted salary is between 60000 - 80000 £ per year.
We are now recruiting a Senior Regulatory Affairs Manager, Europe supporting the Europe region and reporting to the Regulatory Affairs Director, Europe for Neuroscience & Specialty. By joining AbbVie you will play a pivotal role in the implementation of regulatory strategies and deliverables for a portfolio of assets in early/late development or marketed products for the Europe Area Regulatory Affairs (ERA) team, including EU countries and non-EU countries such as Israel, Turkey, Switzerland and the UK. You will identify and advocate the region's requirements in the overarching global regulatory strategy, and develop risk assessment for projects and ensure they are considered at the Global Regulatory Product Team (GRPT).
Main Accountabilities
- Works independently, informs line manager.
- 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.
- Ensures 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.
- Defines regional strategy and supports global product development strategy(s); outlining options for Scientific Advice/PIP/orphan designation/ Accelerated regulatory pathways.
- Coordinates preparation of briefing packages and lead agency meetings.
- Defines Europe Region filing strategy (including CP, MRP, DCP); identifying risks and issues.
- GRPT & ARPT representative ensuring regulatory requirements/interests of Area and Affiliates are represented at GRPT.
- Drives and leads regulatory activities in support of lifecycle management and maintenance in the region.
- Identifies compliance risks proactively.
- 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.
- Responsible for ensuring effective planning, tracking, archiving of activities, especially submissions, internal memos and key correspondence.
- Ensures effective planning and tracking of activities via RIM system.
- Supports the communication of regulatory strategy in support of new product registration, in line with commercial objectives.
People
- Builds strong and effective relationships with Area, Affiliate & Global regulatory & cross‑functional teams to ensure Area and local RA activities are in line with regional business priorities.
- May be required to mentor less experienced staff as needed.
Processes
- Follows core Global and Area Regulatory policies and procedures.
- Supports development and implementation of new processes and ensures that these meet regional regulations and needs.
- Provides input into development of processes and supports implementation, as required.
- Responsible for the notification of Regulatory activities and related database entry/data accuracy for allocated projects.
- Responsible for ensuring forecasts are developed and actuals managed in line with regional requirements and communicating these to GRL and R&D finance for assigned projects.
Qualifications
- Graduate in pharmacy, biology, chemistry, pharmacology or a related Life Sciences subject.
- Sound knowledge of both pharmaceutical regulations and guidelines and national regulations within the assigned region.
- Pharmaceutical industry experience in European Regulatory strategy development and regulatory procedures (including CP/DCP/MRP).
- Experience of EU strategy for development assets e.g. scientific advice, paediatric investigation plans.
Essential Skills and Abilities
- Excellent organisational skills and solution driven leadership style.
- Ability to prioritise and manage workload including managing multiple projects.
- Ability to work effectively and collaboratively across the AbbVie organisation.
- Experienced in working effectively across cultures and in a complex matrix environment.
- Good interpersonal and negotiation skills and the ability to influence others.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.
Senior Regulatory Affairs Manager, Europe in Thatcham employer: Initial Therapeutics, Inc.
AbbVie is an exceptional employer that fosters a collaborative and innovative work culture, particularly for the Senior Regulatory Affairs Manager role in Europe. With a strong commitment to employee growth, AbbVie offers opportunities for professional development and mentorship, ensuring that team members can thrive in their careers while contributing to meaningful advancements in healthcare across diverse European markets.
Contact Details:
Initial Therapeutics, Inc. Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Senior Regulatory Affairs Manager, Europe in Thatcham
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. We all know that sometimes it’s not just what you know, but who you know that can help you land that Senior Regulatory Affairs Manager role.
✨Tip Number 2
Prepare for interviews by researching the company and its products. We want you to be able to discuss how your experience aligns with their regulatory strategies. Show them you’re not just another candidate; you’re the one they need!
✨Tip Number 3
Practice your pitch! You should be able to clearly articulate your experience and how it relates to the role. We recommend doing mock interviews with friends or mentors to get comfortable with your delivery.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Senior Regulatory Affairs Manager, Europe in Thatcham
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Senior Regulatory Affairs Manager role. Highlight your experience in regulatory strategy development and any specific knowledge of EU regulations that aligns with what we're looking for.
Craft a Compelling Cover Letter:Your cover letter should tell us why you're the perfect fit for this role. Share specific examples of how you've successfully navigated regulatory challenges in the past, especially in the European context.
Showcase Your Skills:Don’t forget to emphasise your organisational skills and ability to manage multiple projects. We want to see how you’ve led teams or mentored others in your previous roles, so make that clear!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role without any hiccups!
How to prepare for a job interview at Initial Therapeutics, Inc.
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of European regulatory frameworks and guidelines. Familiarise yourself with the specific regulations that apply to the neuroscience and specialty sectors, as well as any recent changes in legislation. This will show that you're not just a candidate, but someone who is genuinely invested in the field.
✨Showcase Your Strategic Thinking
Be prepared to discuss how you've developed and implemented regulatory strategies in previous roles. Think about specific examples where you identified risks and proposed solutions. This will demonstrate your ability to think critically and strategically, which is crucial for the Senior Regulatory Affairs Manager position.
✨Build Relationships
Since this role involves collaboration with various teams, be ready to talk about how you've built strong relationships in past positions. Share examples of how you've worked effectively across cultures and within complex matrix environments. Highlighting your interpersonal skills will set you apart from other candidates.
✨Prepare for Scenario Questions
Expect scenario-based questions that assess your problem-solving abilities. Think about potential challenges you might face in this role, such as compliance issues or project delays, and prepare your responses. This will help you demonstrate your solution-driven leadership style and your ability to manage multiple projects effectively.
