Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Lead regulatory strategies for oncology products and ensure compliance with UK regulations.
- Company: Join AbbVie, a leader in innovative medicines and impactful health solutions.
- Benefits: Hybrid work model, competitive salary, and excellent career growth opportunities.
- Why this job: Make a real difference in patients' lives while advancing your career in a dynamic environment.
- Qualifications: Experience in regulatory affairs within the pharmaceutical industry and strong communication skills.
- Other info: Collaborative culture with opportunities to influence key health outcomes.
The predicted salary is between 60000 - 75000 £ per year.
Company Description
AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com.
Job Description
Reporting to Regulatory Manager, Oncology UK/ Ireland scope Hybrid-office based in Maidenhead (Tues, Wed, Thurs). Excellent career opportunities for UK and European positions in AbbVie.
Job Overview
Acts as the primary Regulatory contact for UK Oncology. Supports lifecycle management of applicable products, management of paediatric investigation plans and clinical trial activities with the Medicines and Healthcare Products Regulatory Agency (MHRA). Develops regulatory strategies and updates to cross functional team. Maintains relationships with Area Regulatory team to advocate the UK strategy objectives and timelines. Serves as Health Authority liaison and interface for Health Authority meetings to obtain optimal outcomes for patients and AbbVie’s portfolio. Supports the business in planning for and execution of product launches, acquisitions and divestitures, as required. Regulatory intelligence and external landscape monitoring – provides regulatory impact assessment and establishes best practice.
Key Responsibilities
- Regulatory Strategy and Tactical Implementation
- Acts as an interface between the Area and Brand teams.
- Ensures submission and content of new Marketing Authorisations, variations and other regulatory submissions, paediatric investigation plans and clinical trials are made in accordance with appropriate timings and requirements and maintains appropriate tracking of the process as applicable.
- Supports the conduct technical assessments.
- Reviews regulatory submissions for UKRA team for assigned areas of responsibility, corrects where necessary and provides feedback, as required.
- Monitors regulatory intelligence and external landscape for identified portfolio/area of responsibility and cascades information, as appropriate.
- Regulatory Compliance
- Ensures adherence to AbbVie’s policies and procedures to meet statutory, quality and business requirements.
- Acts as a regulatory contact for audits and inspections in the UK as appropriate and has oversight of divisional policies and procedures.
- Ensures compliance with UK legislation for Medicines, Medical Devices, clinical trials and paediatric investigation plans and has an awareness of the ABPI code.
- Acts as Regulatory liaison with Area and local UK cross functional teams to ensure UK strategies align with global strategies, whilst maintaining compliance with local regulations.
- Understand and articulate the regulatory perspective across the business, translating key regulatory decisions in terms of impact on products in the UK.
- Acts as deputy to the UK Regulatory leader on committees/initiatives as required.
- Leadership for UK Regulatory Therapeutic portfolio
- Provides strong leadership for identified portfolio support: Successful implementation of regulatory product strategies.
- Develops and maintains strong working relationships with MHRA.
Qualifications
- Regulatory professional with relevant experience in the pharmaceutical industry with a clear understanding of the UK regulatory submissions process.
- Strong diplomacy, influencing and presentation skills.
- Consultative and collaborative interpersonal style.
- Excellent written, verbal and interpersonal skills.
- Ability to work effectively and collaboratively across cultures and cross-functionally.
- Ability to identify compliance risks and accelerate when necessary.
- Life Sciences Degree in relevant subject area is preferred.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
Senior Project Manager, Regulatory Affairs - Oncology in Maidenhead employer: Allergan
Contact Detail:
Allergan Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Project Manager, Regulatory Affairs - Oncology in Maidenhead
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those at AbbVie. A friendly chat can sometimes lead to opportunities that aren’t even advertised.
✨Tip Number 2
Prepare for interviews by researching AbbVie’s recent projects and regulatory strategies. Show us you’re not just interested in the role but also in how you can contribute to our mission in oncology.
✨Tip Number 3
Practice your pitch! Be ready to explain how your experience aligns with the responsibilities of the Senior Project Manager role. We want to hear how you can make an impact on our regulatory affairs team.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re serious about joining our team.
We think you need these skills to ace Senior Project Manager, Regulatory Affairs - Oncology in Maidenhead
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior Project Manager role in Regulatory Affairs. Highlight your relevant experience in oncology and regulatory submissions, as this will show us you understand what we're looking for.
Craft a Compelling Cover Letter: Your cover letter should tell us why you're passionate about regulatory affairs and how your skills align with our mission at AbbVie. Be genuine and let your personality shine through!
Showcase Your Achievements: When detailing your experience, focus on specific achievements that demonstrate your ability to lead projects and navigate regulatory landscapes. Numbers and outcomes can really make your application stand out to us.
Apply Through Our Website: We encourage you to apply directly through our website. This ensures your application gets to the right people and shows us you're serious about joining our team at AbbVie!
How to prepare for a job interview at Allergan
✨Know Your Regulatory Stuff
Make sure you brush up on the UK regulatory submissions process and any recent changes in legislation. AbbVie is looking for someone who can navigate this landscape with ease, so be prepared to discuss your experience and how it aligns with their needs.
✨Showcase Your Leadership Skills
As a Senior Project Manager, you'll need to demonstrate strong leadership capabilities. Think of examples where you've successfully led teams or projects, especially in a regulatory context. Be ready to share how you foster collaboration and drive results.
✨Prepare for Scenario Questions
Expect questions that assess your problem-solving skills and ability to handle compliance risks. Prepare specific scenarios from your past experiences where you had to make tough decisions or influence stakeholders, and explain the outcomes.
✨Understand AbbVie's Mission
Familiarise yourself with AbbVie's mission and therapeutic areas, particularly oncology. Show genuine interest in how your role as a Regulatory contact can contribute to their goals. This will demonstrate your alignment with their values and commitment to improving patient outcomes.