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- Tasks: Lead regulatory strategy and submissions for innovative CNS programs in a dynamic biotech environment.
- Company: Join a cutting-edge biotech firm focused on transformative therapies.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Collaborative team culture with excellent career advancement opportunities.
- Why this job: Make a real impact in drug development and shape the future of healthcare.
- Qualifications: 6+ years in Regulatory Affairs with strong communication and project management skills.
The predicted salary is between 70000 - 90000 £ per year.
The Associate Director of Regulatory Affairs Strategy will work on assigned programs with the respective Global Regulatory Portfolio Lead, Global Regulatory Lead and cross-functional team to lead the regulatory strategy and facilitate submission of data packages to the EMA. The role is expected to serve as an EU Regional Lead for our mid/late-stage CNS programs and may have the opportunity to be the Regulatory Program Lead for early programs in Alnylam pipeline.
The role is responsible for planning and coordinating all aspects of regulatory submissions necessary to support product development, clinical trials and product registration. The role will represent RA on multidisciplinary product development subteams and Global Regulatory Team. Additional responsibilities include involvement in the writing and oversight of regulatory submissions, coordinating all aspects of paper and electronic regulatory submissions, proactively keeping updated on EU regulatory requirements, and interpreting regulatory intelligence for the internal teams.
Summary of Key Responsibilities- Serve as EU Regional Lead for assigned program, or as Regulatory Program Lead, leading the Global Regulatory Team, for one of the early programs in the Alnylam pipeline.
- Work with the Global Regulatory Lead and Regulatory Affairs management to lead and define regulatory strategy and to compile and submit, in a timely manner, regulatory documents according to regulatory requirements and lead EU HA interactions.
- Regulatory documents may include the relevant forms, meeting requests, Briefing Documents for HA meetings, new Clinical Trial Applications (CTAs), Marketing Applications, Paediatric Plans, Orphan Designation and Expedited Pathway Applications (e.g. PRIME), and any amendments.
- Develop detailed regulatory project plans and support regulatory activities relating to specific portfolio of products/projects.
- Serve as member of the Global Regulatory Team, may serve as Regulatory representative in multidisciplinary product subteams or core team for assigned programs and participate as an active team member.
- Coordinate responses to regulatory authorities’ questions with strict adherence to deadlines.
- Serve as a liaison within internal departments at Alnylam, with CROs and with regulatory program managers at HAs.
- Maintain regulatory files in a format consistent with internal requirements.
- Facilitate as necessary the review of technical regulatory documentation and recommend changes to documentation or processes, including SOPs for regulatory compliance.
- Provide EU specific regulatory intelligence to internal stakeholders as appropriate.
- Bachelor's degree with 6 or more years of experience in a Regulatory Affairs role; minimum of 8 years’ experience working in the biotech or pharmaceutical industry. Higher degree would be a plus.
- Excellent written and verbal communication skills, including negotiation and influencing skills.
- Solid understanding of regulations and experience in interpretation of guidelines.
- Ability to think strategically and to proactively identify issues and mitigation strategies in various aspects of the drug development process.
- Experience with regulatory filings, including electronic submissions, e.g., CTAs, post-marketing variations, safety reporting, paediatric plans, PRIME etc. MAA filing and Type II variation experience is preferred.
- Excellent organizational and project management skills; demonstrated ability to prioritize multiple projects.
- Ability to work in a team environment, possessing interpersonal skills to work effectively with other departments at various levels and with CROs and external consultants.
- Technical system skills (e.g. word processing, spreadsheets, databases, online research) including submission-ready formatting.
- Clear alignment with Alnylam Core Values.
Associate Director Regulatory Affairs employer: Alnylam Pharmaceuticals
Contact Detail:
Alnylam Pharmaceuticals Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Director Regulatory Affairs
✨Tip Number 1
Network like a pro! Reach out to folks in your industry on LinkedIn or at events. A friendly chat can lead to opportunities that aren’t even advertised yet.
✨Tip Number 2
Prepare for interviews by researching the company and its products. Knowing their pipeline and recent news can help you stand out and show your genuine interest.
✨Tip Number 3
Practice your pitch! Be ready to explain how your experience aligns with the role of Associate Director in Regulatory Affairs. Confidence is key, so rehearse until it feels natural.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we love seeing candidates who are proactive!
We think you need these skills to ace Associate Director Regulatory Affairs
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter to highlight your experience in regulatory affairs, especially with EU submissions. We want to see how your background aligns with the role of Associate Director, so don’t hold back on showcasing relevant projects!
Showcase Your Communication Skills: Since excellent written and verbal communication is key for this role, use your application to demonstrate these skills. Keep your language clear and concise, and make sure to proofread for any typos or errors before hitting send!
Highlight Your Strategic Thinking: We’re looking for someone who can think strategically about regulatory processes. In your application, share examples of how you’ve proactively identified issues and developed solutions in past roles. This will show us you’re ready to take on the challenges of the position.
Apply Through Our Website: Don’t forget to submit your application through our website! It’s the best way for us to receive your details and ensures you’re considered for the role. Plus, it gives you a chance to explore more about what we do at StudySmarter!
How to prepare for a job interview at Alnylam Pharmaceuticals
✨Know Your Regulatory Stuff
Make sure you brush up on the latest EU regulatory requirements and guidelines. Familiarise yourself with the specific documents you'll be dealing with, like CTAs and MAAs. This will show that you're not just knowledgeable but also proactive about staying updated in the field.
✨Showcase Your Project Management Skills
Be ready to discuss your experience in managing multiple projects simultaneously. Prepare examples of how you've prioritised tasks and met deadlines in previous roles. This is crucial for demonstrating your organisational skills and ability to handle the fast-paced nature of regulatory affairs.
✨Communicate Clearly and Confidently
Since excellent communication is key in this role, practice articulating your thoughts clearly. Be prepared to discuss how you've influenced stakeholders or navigated complex negotiations in the past. This will highlight your verbal skills and ability to work effectively with cross-functional teams.
✨Prepare for Team Dynamics
Think about your experiences working in multidisciplinary teams. Be ready to share how you've collaborated with different departments and external partners. This will demonstrate your interpersonal skills and ability to thrive in a team environment, which is essential for the Associate Director role.