At a Glance
- Tasks: Lead global CMC regulatory strategies for hematology and oncology portfolios.
- Company: Join a leading biotech firm committed to innovation and inclusivity.
- Benefits: Competitive salary, flexible work schedule, and opportunities for professional growth.
- Other info: Mentorship and training opportunities in a dynamic, supportive environment.
- Why this job: Make a real impact in the fight against cancer while advancing your career.
- Qualifications: 10+ years in pharma/biotech with strong CMC experience required.
The predicted salary is between 80000 - 100000 £ per year.
Location: Uxbridge, Ontario – on site 3 days a week, remote 2 days a week.
Responsibilities
- Lead development & execution of global CMC regulatory strategies for hematology and oncology portfolios.
- Guide regulatory activities across development stages and mentor CMC RA staff.
- Represent CMC RA at program meetings and provide regulatory interpretation, positioning, and coverage of clinical development, market applications, and approval/post‑approval activities.
- Identify program issues and develop risk mitigation strategies, alternatives, and consensus.
- Review & provide strategic input on regulatory filing documents (INDs, IMPDs, meeting packages, scientific advice, BLAs, MAAs, BPDRs, annual reports, DSUR, amendments, supplements).
- Lead interactions with global regulatory authorities, including meetings, IR responses, and inspections.
- Perform final review/approval of compliance activities and confirm regulatory impact for clinical and commercial filings.
- Mentor colleagues on compliance assessment, guide process improvements, and lead training on SOPs and templates.
- Identify gaps in IOPS and global RA processes, propose improvements, and manage knowledge base of regulatory requirements.
- Initiate operational changes, policy modifications, and coach team members.
Qualifications
- Bachelor’s degree with a minimum of 10 years of pharmaceutical/biotech industry experience, including 5+ years of relevant CMC experience.
- Advanced degree preferred.
- Proven track record supporting biological products through development and approval.
- Strong understanding of current worldwide CMC regulations and guidelines.
- Experience interacting with US FDA and other regulatory authorities.
- Experience with device regulatory requirements and combination product development processes is a plus.
Benefits and EEO Statement
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief, sex, sexual orientation, gender identity or expression, marital status, civil partnership, citizenship, disability, or other protected characteristics. Reasonable accommodations will be provided to applicants with known disabilities or chronic illnesses within the recruitment process, unless it would impose undue hardship.
Associate Director, CMC Regulatory Affairs (Hematology/Oncology) employer: BioSpace
Regeneron is an exceptional employer that fosters a collaborative and innovative work culture, particularly in the dynamic field of CMC Regulatory Affairs. Located in Uxbridge, Ontario, employees benefit from a flexible work arrangement, allowing for a balanced blend of on-site and remote work. With a strong commitment to employee growth, Regeneron offers extensive mentorship opportunities and encourages continuous learning, making it an ideal place for professionals seeking meaningful and rewarding careers in the pharmaceutical industry.
StudySmarter Expert Advice🤫
We think this is how you could land Associate Director, CMC Regulatory Affairs (Hematology/Oncology)
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like BioSpace. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like BioSpace.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like BioSpace. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what BioSpace is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Associate Director, CMC Regulatory Affairs (Hematology/Oncology)
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!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show BioSpace that you're not just a fit for the job but also a safety-conscious candidate!
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.
✨Showcase Relevant Experience
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.
✨Know Their Products
Take some time to familiarise yourself with BioSpace’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
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.
