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- Tasks: Implement regulatory strategies and manage product submissions for innovative medicines.
- Company: Join AbbVie, a leader in healthcare innovation and patient impact.
- Benefits: Full-time role with competitive salary and opportunities for growth.
- Why this job: Make a difference in healthcare while developing your project management skills.
- Qualifications: Degree in life sciences or relevant experience in regulatory affairs.
- Other info: Dynamic team environment with a focus on collaboration and cultural sensitivity.
The predicted salary is between 36000 - 60000 £ 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 Overview: Implement regulatory strategies & deliverables for a portfolio of products early/late development or marketed products for the Europe Area Regulatory Affairs (ERA) including EU and non‐EU countries such as CEE countries, Israel, Turkey, Switzerland and the UK. Responsible for assigned product maintenance and lifecycle management submissions, in line with legal/regulatory requirements and regional business needs. Contribute, as required, in the development of regional processes to maximise operational efficiency of regulatory activities within the region. Develop and maintain knowledge of regulatory procedures and environment within the region.
Key Responsibilities:
- Implement regulatory strategies & deliverables including effective planning, tracking, archiving of activities, especially submissions for early/late development and marketed products.
- Support coordination of the review of CMC, QRD, PSUR and labelling submissions and approval of product‐related packaging as required.
- Support the drug development strategy, defining options for including supporting Scientific Advice/PIP/IMPD, creating briefing packages and coordinating and leading agency meetings logistics.
- Provide strategic input for registration, ensure the business needs are met by anticipating and mitigating regulatory risks.
- Primary interface to and from the RA personnel in the affiliates and provides product updates in Area Regulatory Product Teams (ARPTs).
- Ensure regulatory compliance within ERA for the assigned compounds/products. Implement remediation plan to address identified gaps, if any.
- Responsible for the Notification of Regulatory activities and related database entry/data accuracy for allocated projects.
Qualifications:
- Graduate in pharmacy, biology, chemistry, pharmacology or a related Life Sciences subject or related experience.
- Sound knowledge of both pharmaceutical regulations and guidelines and national regulations within the assigned region.
- Prior relevant experience in pharmaceutical Regulatory Affairs.
- Demonstrated planning and organisation skills.
- Ability to prioritise and manage multiple projects.
- Good interpersonal and negotiation skills and the ability to influence others without formal authority.
- Excellent communication skills, both written and verbal (in English).
- Willingness to travel as necessary (5% at least).
- Computer literate.
Additional Information: AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.
Project Manager, Regulatory Affairs employer: AbbVie
Contact Detail:
AbbVie Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Project Manager, Regulatory Affairs
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those working at AbbVie or similar companies. A friendly chat can open doors and give you insights that job descriptions just can't.
✨Tip Number 2
Prepare for interviews by researching AbbVie’s recent projects and regulatory challenges. Show us you’re not just another candidate; demonstrate your passion for their mission and how you can contribute to their goals.
✨Tip Number 3
Practice your pitch! Be ready to explain how your skills in regulatory affairs align with AbbVie’s needs. We want to hear how you can tackle their specific challenges and make an impact from day one.
✨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 and ready to take the next step in your career.
We think you need these skills to ace Project Manager, Regulatory Affairs
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Project Manager role in Regulatory Affairs. Highlight relevant experience and skills that match the job description, especially your knowledge of pharmaceutical regulations and project management.
Craft a Compelling Cover Letter: Your cover letter should tell us why you're the perfect fit for this role. Share specific examples of your past experiences that demonstrate your ability to implement regulatory strategies and manage multiple projects effectively.
Showcase Your Communication Skills: Since excellent communication is key for this role, ensure your written application reflects your ability to convey complex information clearly. Use concise language and structure your application well to make it easy for us to read.
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. This way, you can ensure all your documents are submitted correctly and you’ll be considered for the role directly by our team.
How to prepare for a job interview at AbbVie
✨Know Your Regulatory Stuff
Make sure you brush up on the latest pharmaceutical regulations and guidelines relevant to the role. AbbVie is looking for someone who understands both EU and non-EU regulations, so be prepared to discuss how your knowledge can help them navigate these complexities.
✨Showcase Your Project Management Skills
Be ready to talk about your experience in managing multiple projects simultaneously. Highlight specific examples where you've successfully implemented regulatory strategies or coordinated submissions, as this will demonstrate your ability to handle the responsibilities of the role.
✨Communicate Effectively
Since excellent communication skills are essential, practice articulating your thoughts clearly and concisely. Prepare to discuss how you've influenced others in previous roles without formal authority, as this will show your interpersonal skills and ability to work collaboratively.
✨Demonstrate a Positive Attitude
AbbVie values a 'can-do' attitude, so come across as enthusiastic and adaptable during the interview. Share examples of how you've tackled challenges in the past and how your positive mindset has contributed to successful outcomes in your projects.
