At a Glance
- Tasks: Lead regulatory strategies and manage a dynamic team in the pharmaceutical industry.
- Company: Join AbbVie, a leader in innovative medicines and health solutions.
- Benefits: Enjoy excellent benefits, career progression, and a collaborative work environment.
- Other info: Work in a vibrant team with opportunities for personal and professional growth.
- Why this job: Make a real impact on healthcare while developing your leadership skills.
- Qualifications: Experience in regulatory affairs and strong people management skills required.
The predicted salary is between 51750 - 63250 £ per year.
Company Description
Abb Vie'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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio.
For more information about Abb Vie, please visit us at www. abbvie. co. uk.
Follow @abbvie on Linked In, Facebook, Instagram, X and You Tube.
Job Description
- Located in Maidenhead (3 days per week Tuesday, Wednesday, Thursday)
- Aligned with Neuroscience business unit
- Excellent benefits and opportunities to progress
- Job Overview
- Acts as the primary Regulatory contact for identified therapeutic area of responsibility.
- Provides line management responsibility for a small team within UK Regulatory Affairs, including recruitment, goal setting, performance appraisal and talent development.
- Oversees all regulatory activities within therapeutic area of responsibility, including maintaining licensing whilst contributing to the Brand Team priorities.
- Uses experience and knowledge of the regulatory landscape to guide team to develop robust regulatory strategies and timely submissions to the Medicines and Healthcare Products Agency (MHRA), ensuring the fastest approvals, implementations and product launches.
- Develops and maintains relationships with Area & Affiliate members of GRS Europe and cross functional partners share knowledge, increase regulatory awareness and build networks.
- Engages externally with the Health Authority on regulatory submissions and/or other pharmaceutical industry trade associations, as required.
- Supports the business in planning for and execution of product launches, acquisitions and divestitures, as required.
- Key Accountabilities
- Regulatory Strategy and Tactical Implementation
- Provides clear guidance and recommendations on UK regulatory strategies and tactical plans throughout a product lifecycle including clinical trial submissions, management of variations, paediatric investigation plans, new marketing authorisation applications and liaison with local regulatory authorities.
- Reviews regulatory submissions for UKRA team for assigned areas of responsibility, corrects where necessary and provides feedback.
- Regulatory intelligence and external landscape monitoring
- Interacts with Regulatory policy makers and professional associations (eg ABPI) to gather knowledge about trends, future changes and current landscape in accordance with the national and EU legislation and relevant Associations Codes and advocate for Abb Vies interests.
- Regulatory Compliance
- Ensures compliance with Abb Vies policies and procedures to meet statutory, quality and business requirements, acting as primary point of regulatory contact for audits and inspections in the UK as appropriate and supporting 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.
- Liaison with Internal Stakeholders
- 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 lead Regulatory representative on Affiliate committees/initiatives (as required).
- Acts as deputy to the UK Regulatory Affairs Managers and/or Director (as required).
- Leadership for UK Regulatory Therapeutic team
- Provides strong leadership and direction to the UK Regulatory Therapeutic Regulatory team to support:
- Successful implementation of regulatory product strategies
- Develops and maintains strong working relationships with MHRA and local pharmaceutical company trade associations
- Process improvements, internal compliance and team consistency
- Individual professional development, improved capability and upskilling within team
- Supports recruitment activities (as required) and retain high calibre regulatory affairs professionals
Qualifications
- Experienced Regulatory professional in the pharmaceutical industry with a clear understanding of the UK regulatory and submissions process
- Experience as a line manager with highly developed people skills
- Sense of personal responsibility and accountability, with a positive, can-do attitude
- Ability to multitask, prioritise, and manage multiple projects and deadlines
- Ability to work effectively and collaboratively across cultures and cross-functionally
- Strong diplomacy, influencing, presentation skills
- Personal Skills
- Consultative and collaborative interpersonal style
- Excellent written, verbal and interpersonal skills (in English)
- Ability to identify compliance risks and elevate when necessary
- Life Sciences Degree in relevant subject area
- Computer literate
- Additional Information
Abb Vie 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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Senior Manager, Regulatory Affairs in Maidenhead employer: BioSpace
Moderna is an exceptional employer that fosters a collaborative and innovative work culture, particularly in the vibrant Harwell location. Employees benefit from competitive healthcare, generous paid time off, and a holistic approach to well-being, alongside opportunities for professional growth and development in cutting-edge mRNA science. Joining our team means making a meaningful impact on patients' lives while working with talented colleagues in a supportive environment.
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We think this is how you could land Senior Manager, Regulatory Affairs in Maidenhead
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We think you need these skills to ace Senior Manager, Regulatory Affairs in Maidenhead
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at BioSpace!
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Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at BioSpace!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At BioSpace, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at BioSpace
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at BioSpace that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
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If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
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In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
