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- Tasks: Lead regulatory submissions and collaborate with teams to ensure compliance and success.
- Company: Fast-growing pharmaceutical company with a dynamic and innovative culture.
- Benefits: Permanent, full-time role with hybrid working options and career growth opportunities.
- Why this job: Make a real impact in the pharmaceutical industry while working on exciting new drug applications.
- Qualifications: 7+ years in Regulatory Affairs with expertise in EU requirements and product lifecycle management.
- Other info: Join a collaborative team in a fast-paced environment focused on innovation.
The predicted salary is between 36000 - 60000 ÂŁ per year.
Blackfield Associates are supporting a fast moving pharmaceutical company who, due to consistent growth, are looking for an experienced Senior Regulatory Affairs Manager, who will lead interactions with the health authorities and manage new MAA/new drug applications.
We are looking for an expert in DCP cycles, able to author dossiers. As Senior Regulatory Affairs Manager, you will:
- Review and assess adequacy of the nonâclinical and clinical data package for regulatory submission based on available scientific guidance, precedence, previous experience and any scientific communication with any health authority if available specific to the development program.
- Seek clarification from the developer to make informed decisions, work cross-functionally to assess risks/mitigation, and assess need that may benefit from any further regulatory HA interaction.
- Actively be involved in due diligence of the dossier covering modules 1 to 5 and will be responsible for assessing adequacy of these sections and any responses to questions during review.
- Work collaboratively with internal stakeholders and external stakeholders to finalise sections of MAA.
- Contribute actively in any future development plans by working closely with the new products team to define regulatory strategy required to support MAA.
- Support postâapproval regulatory activities to ensure timely preparation of various documents and studies required by EMA for an EU orphan registered product.
- Work closely with internal teams and other CROs supporting these efforts.
- Support the coordination and registration of assigned generic products in coordination with the internal teams.
To be considered for the role of Senior Regulatory Affairs Manager, you will have:
- A minimum of 7 years experience in Regulatory, working hands-on with new/initial indications and new MAA.
- Proven experience with EU regulatory requirements, particularly with Decentralised Procedures.
- Clear experience gained from managing product lifecycle, including Marketing Authorisation submissions (DCPs, MRPs), set up and implement postâapproval lineâextension and variation strategies, maintenance activities.
- The right candidate will be a technical, autonomous individual with ambition and comfortable with a fast-paced regulatory environment.
This is a permanent, full-time position based in Slough. This role is an individual contributor, working in a matrix environment with rapid expansion. Hybrid working. All candidates must have the valid right to work; this opportunity is unable to sponsor.
Senior Manager Regulatory Affairs in England employer: Blackfield Associates
Contact Detail:
Blackfield Associates Recruiting Team
StudySmarter Expert Advice đ¤Ť
We think this is how you could land Senior Manager Regulatory Affairs in England
â¨Network Like a Pro
Get out there and connect with people in the industry! Attend conferences, webinars, or local meetups. You never know who might have the inside scoop on job openings or can put in a good word for you.
â¨Show Off Your Expertise
When you get the chance to chat with potential employers, donât hold back! Share your knowledge about DCP cycles and MAA submissions. Let them see that youâre not just another candidate, but someone who knows their stuff.
â¨Follow Up Like a Boss
After interviews or networking events, drop a quick thank-you email. It shows your enthusiasm and keeps you fresh in their minds. Plus, itâs a great opportunity to reiterate why youâre the perfect fit for the Senior Regulatory Affairs Manager role.
â¨Apply Through Our Website
Donât forget to check out our website for the latest job openings! Applying directly through us can sometimes give you an edge, as we love seeing candidates who are proactive and engaged with our company.
We think you need these skills to ace Senior Manager Regulatory Affairs in England
Some tips for your application đŤĄ
Tailor Your CV: Make sure your CV is tailored to the Senior Regulatory Affairs Manager role. Highlight your experience with MAA submissions and DCP cycles, as these are key for us. Use specific examples that showcase your expertise in regulatory affairs.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Explain why you're the perfect fit for this fast-paced environment. Mention your hands-on experience with EU regulatory requirements and how youâve successfully managed product lifecycles in the past.
Showcase Your Collaborative Skills: Since this role involves working closely with various stakeholders, make sure to highlight your teamwork skills. Share examples of how you've collaborated with internal teams or CROs to achieve regulatory goals.
Apply Through Our Website: We encourage you to apply directly through our website. Itâs the best way for us to receive your application and ensures it gets into the right hands quickly. Plus, it shows youâre keen on joining our team!
How to prepare for a job interview at Blackfield Associates
â¨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of EU regulatory requirements, especially around Decentralised Procedures. Be ready to discuss your hands-on experience with new MAA submissions and how you've managed product lifecycles in the past.
â¨Prepare for Scenario Questions
Expect questions that ask you to assess the adequacy of non-clinical and clinical data packages. Think about specific examples where you've had to seek clarification from developers or work cross-functionally to mitigate risks.
â¨Show Your Collaborative Spirit
This role involves working closely with both internal and external stakeholders. Be prepared to share examples of how you've successfully collaborated in the past, particularly in finalising sections of MAAs or coordinating with CROs.
â¨Demonstrate Your Autonomy and Ambition
The company is looking for a technical, autonomous individual. Highlight instances where you've taken initiative in a fast-paced environment and how your ambition has driven successful outcomes in your previous roles.
