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For Companies At a Glance
- Tasks: Support regulatory processes and ensure compliance for innovative medicines.
- Company: Join AbbVie, a leader in healthcare dedicated to solving serious health issues.
- Benefits: Enjoy a collaborative culture with opportunities for growth and innovation.
- Why this job: Make a real impact on patient lives while working in a dynamic environment.
- Qualifications: Life Sciences degree or equivalent experience; strong communication and project management skills.
- Other info: AbbVie values diversity and is committed to equal opportunity.
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 atwww.abbvie.com. Follow @abbvie onX,Facebook,Instagram,YouTube,LinkedInandTik Tok.
Job Description
MISSION:
The Regulatory Affairs Specialist supports the regulatory vision and leadership of the Regulatory Team. They execute these responsibilities by utilizing experience, knowledge of regulatory landscape, passion and creativity to provide patient-centric and compliant regulatory expertise in line with AbbVie’s vision . They support the best interests of patients, the Affiliate and AbbVie within the country with regard to interactions with the regulatory agency and other regulatory authorities . Within AbbVie t he y represent the department and affiliate to the wider organization thro ughout the product lifecycle. They contribute to the department \’s overall success by executing tactics and meeting objectives in line with business goals and culture.
Overall responsibilities (together with manager’s oversight)
- Supports the business of the company including involvement in planning for product launches, acquisitions and divestitures
- Lifecycle management of applicable products and management of Clinical Trial activities with the MHRA
- Work with Area Regulatory team to help advocate for the affiliate\’s strategy, objectives and timelines
- Works with the regulatory department and collaborates other stakeholders, as appropriate, to ensure compliance with the company’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives of AbbVie
- Authors SOPs, workflows and guides relevant to regulatory processes as required.
Main Accountabilities
- Gain regulatory authority approval for new clinical trials and amendments to such trials undertaken by AbbVie Ltd in the UK
- Gain marketing authorisations for new pharmaceutical products in the UK
- Maintain marketing authorisations as required.
- Liaise with European Regulatory Affairs and Corporate groups on regulatory issues.
- Liaise with external regulatory authorities as required.
- Draft of packaging texts, SmPCs, PILs and Prescribing Information.
- Submit and obtain approval for Paediatric Investigation Plans (PIP)
- Maintain awareness of current and new legislation/guidance and ensure that work is in compliance with the statutory requirements.
Qualifications
Required Education / Knowledge / Experience
- Life Sciences Degree (e.g. Pharmacy) or equivalent experience preferred
- Experience of working in a regulatory environment
- Good communication skills, both verbal and written
- The ability to thrive in a changing environment and to re-prioritise workload to meet business needs
- Good project management skills desirable
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.
US & Puerto Rico only – to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
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Regulatory Affairs Specialist employer: Allergan Aesthetics
Contact Detail:
Allergan Aesthetics Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Specialist
✨Tip Number 1
Familiarise yourself with AbbVie's mission and values. Understanding their focus on innovative medicines and patient-centric solutions will help you align your responses during interviews and demonstrate your enthusiasm for their work.
✨Tip Number 2
Network with current or former employees of AbbVie, especially those in regulatory affairs. They can provide valuable insights into the company culture and expectations, which can be beneficial when preparing for interviews.
✨Tip Number 3
Stay updated on the latest regulatory changes and trends in the pharmaceutical industry. Being knowledgeable about current legislation and guidance will show your commitment to the role and your ability to adapt to a changing environment.
✨Tip Number 4
Prepare specific examples from your past experiences that showcase your project management skills and ability to work collaboratively. Highlighting these skills will demonstrate your readiness to contribute effectively to AbbVie's regulatory team.
We think you need these skills to ace Regulatory Affairs Specialist
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly understand the responsibilities and qualifications required for the Regulatory Affairs Specialist position at AbbVie. This will help you tailor your application to highlight relevant experiences.
Tailor Your CV: Customise your CV to reflect your experience in regulatory affairs, particularly in areas like clinical trials and marketing authorisations. Use specific examples that demonstrate your skills and achievements related to the job description.
Craft a Compelling Cover Letter: Write a cover letter that not only outlines your qualifications but also expresses your passion for the role and AbbVie's mission. Mention how your background aligns with their goals in the therapeutic areas they focus on.
Proofread and Edit: Before submitting your application, carefully proofread all documents for spelling and grammatical errors. A polished application reflects attention to detail, which is crucial in regulatory affairs.
How to prepare for a job interview at Allergan Aesthetics
✨Understand the Regulatory Landscape
Familiarise yourself with the current regulations and guidelines relevant to the pharmaceutical industry, especially those pertaining to clinical trials and marketing authorisations in the UK. This knowledge will demonstrate your commitment and readiness for the role.
✨Showcase Your Communication Skills
As a Regulatory Affairs Specialist, effective communication is key. Prepare to discuss how you've successfully communicated complex regulatory information to various stakeholders in the past. Use specific examples to illustrate your points.
✨Demonstrate Project Management Abilities
Be ready to talk about your experience managing projects, particularly in a regulatory context. Highlight any tools or methodologies you’ve used to keep projects on track and how you adapt to changing priorities.
✨Prepare Questions for the Interviewers
Think of insightful questions to ask your interviewers about AbbVie's regulatory strategies and challenges. This shows your genuine interest in the company and the role, and it can help you assess if it's the right fit for you.
