At a Glance
- Tasks: Lead regulatory activities across EMEA and emerging markets for a global pharmaceutical company.
- Company: Join an international pharmaceutical organisation with a focus on innovation and expansion.
- Benefits: Permanent, full-time role with hybrid working options and flexibility around hours.
- Other info: Collaborative team environment with opportunities for professional growth.
- Why this job: Make a real impact in global health by managing regulatory submissions and product lifecycle.
- Qualifications: Degree in Life Sciences and 5+ years in international regulatory affairs required.
The predicted salary is between 60000 - 75000 € per year.
Blackfield Associates is proud to be partnered exclusively with an international pharmaceutical organisation that is expanding its International & Emerging Markets Regulatory team. We are seeking an experienced Regulatory Affairs Manager to take ownership of regulatory activities across EMEA and emerging markets. This is a hands‑on role for a regulatory professional with proven experience taking approved dossiers and managing local submissions across emerging markets, including direct interaction with Health Authorities.
Key Responsibilities:
- Prepare and submit new Marketing Authorisation Applications (MAAs) supporting international countries within the Emerging markets region
- Support global expansion through the submission of registration dossiers for existing products
- Lead dossier remediation activities, including aligning legacy registrations with current regulatory requirements to enable geographic expansion
- Support lifecycle management of marketed products, including Variations, Renewals, and PSURs
- Liaise closely with local Regulatory Affairs affiliates on regulatory documentation, including labelling, variations, and new registrations
- Provide hands‑on support for country‑specific labelling requirements
- Track registrations using relevant regulatory databases and tracking systems
- Provide regulatory input to cross‑functional teams, including portfolio management, out‑licensing, and launch management
- Proactively contribute to the development and continuous improvement of the Regulatory Affairs function, supporting the successful commercialisation of products across international markets within EMEA
Required Experience & Qualifications:
- Degree‑qualified in a Life Sciences discipline or related field
- Minimum 5 years’ experience supporting international regulatory markets
- Proven experience managing new MAAs, global expansion of existing products, and extensive lifecycle maintenance (essential)
- Experience working closely with international Regulatory Affairs affiliates
- Strong ability to manage multiple priorities and deadlines simultaneously
- Able to work independently while contributing effectively within a collaborative team environment
Additional Information:
- This is a permanent, full‑time position
- Based at the Slough affiliate office, with hybrid working required
- Sponsorship is not available – candidates must have full right to work in the UK
- Flexibility around working hours is required due to international territories
Manager (m/w/d) Regulatory Affairs/Compliance in Slough employer: Blackfield Associates
At Blackfield Associates, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters collaboration and innovation within the pharmaceutical sector. Our Slough office provides a supportive environment with flexible working arrangements, ensuring our employees can thrive while contributing to meaningful projects that impact global health. We are committed to employee growth, providing opportunities for professional development and advancement in the rapidly evolving field of Regulatory Affairs.
StudySmarter Expert Advice🤫
We think this is how you could land Manager (m/w/d) Regulatory Affairs/Compliance in Slough
✨Tip Number 1
Network like a pro! Reach out to your connections in the regulatory affairs field, especially those who work in international markets. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of local submission processes and health authority interactions. We want you to shine when discussing your experience with MAAs and lifecycle management!
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your career goals. Check out our website for roles that match your skills in regulatory affairs and make sure to tailor your approach to each opportunity.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can keep you top of mind and show your enthusiasm for the role. Plus, it’s a great chance to reiterate why you’re the perfect fit for managing regulatory activities.
We think you need these skills to ace Manager (m/w/d) Regulatory Affairs/Compliance in Slough
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the specific skills and experiences mentioned in the job description. Highlight your regulatory affairs experience, especially with MAAs and lifecycle management, to show us you’re the right fit for the role.
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re passionate about regulatory affairs and how your background aligns with our needs. Don’t forget to mention your experience with international markets!
Showcase Your Achievements:When detailing your experience, focus on your achievements rather than just responsibilities. Use metrics where possible to demonstrate your impact, like successful submissions or improvements in processes that benefited your previous teams.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates during the process!
How to prepare for a job interview at Blackfield Associates
✨Know Your Regulatory Stuff
Make sure you brush up on the latest regulations and guidelines relevant to the pharmaceutical industry, especially in EMEA and emerging markets. Being able to discuss specific regulatory frameworks and how they apply to your previous experience will show that you're not just familiar with the basics but are truly engaged with the field.
✨Showcase Your Hands-On Experience
Prepare examples of your past work with Marketing Authorisation Applications (MAAs) and lifecycle management. Be ready to discuss specific challenges you faced and how you overcame them, particularly in managing submissions and liaising with Health Authorities. This will demonstrate your practical knowledge and problem-solving skills.
✨Highlight Your Collaborative Spirit
Since this role involves working closely with local Regulatory Affairs affiliates, be prepared to talk about your experience in cross-functional teams. Share instances where you successfully collaborated with others to achieve regulatory goals, as this will highlight your ability to work effectively in a team environment.
✨Stay Organised and Prioritise
Given the need to manage multiple priorities and deadlines, it’s crucial to convey your organisational skills. Discuss tools or methods you use to keep track of registrations and submissions, and how you prioritise tasks to meet tight deadlines. This will reassure them that you can handle the demands of the role.
