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For Companies At a Glance
- Tasks: Lead regulatory strategies for oncology products and collaborate with cross-functional teams.
- Company: Join AbbVie, a leader in innovative medicines and health solutions.
- Benefits: Hybrid work model, excellent career growth, and competitive salary.
- Why this job: Make a real impact on patient lives through groundbreaking oncology therapies.
- Qualifications: Experience in regulatory affairs and strong communication skills required.
- Other info: Dynamic environment with opportunities across UK and Europe.
The predicted salary is between 60000 - 75000 £ per year.
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.
Job Description
Reporting to Regulatory Manager, Oncology UK/ Ireland scope Hybrid-office based in Maidenhead (Tues, Wed, Thurs)
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
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
- Act 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 elevate when necessary
- Life Sciences Degree in relevant subject area is preferred
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.
Senior Project Manager, Regulatory Affairs - Oncology in Maidenhead employer: AbbVie
Contact Detail:
AbbVie 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 open doors and give you insights that a job description just can't.
✨Tip Number 2
Prepare for interviews by knowing your stuff! Research AbbVie’s recent projects in oncology and be ready to discuss how your experience aligns with their mission. Show them you’re not just another candidate!
✨Tip Number 3
Practice makes perfect! Do mock interviews with friends or use online resources. The more comfortable you are talking about your skills and experiences, the better you'll perform when it counts.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you’re serious about joining the team at AbbVie.
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 is your chance to shine! Use it to explain why you're passionate about regulatory affairs in oncology and how your skills align with our mission at AbbVie. Keep it concise but impactful!
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 speak volumes, so don’t shy away from sharing them!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands and shows us you're serious about joining our team at AbbVie!
How to prepare for a job interview at AbbVie
✨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 the complexities of regulatory affairs, so being well-versed in this area will definitely give you an edge.
✨Showcase Your Leadership Skills
As a Senior Project Manager, you'll need to demonstrate strong leadership capabilities. Prepare examples from your past experiences where you've successfully led teams or projects, especially in a regulatory context. This will show that you can handle the responsibilities of the role.
✨Be Ready to Discuss Collaboration
AbbVie values teamwork, so be prepared to talk about how you've worked cross-functionally in previous roles. Think of specific instances where your consultative style made a difference in achieving project goals, particularly in a regulatory setting.
✨Prepare Questions for Them
Interviews are a two-way street! Have some thoughtful questions ready about AbbVie's regulatory strategies or their approach to product launches. This shows your genuine interest in the company and the role, and it gives you a chance to assess if it's the right fit for you.