At a Glance
- Tasks: Drive regulatory strategy for innovative muscle disease therapies in a fast-paced biotech environment.
- Company: Exciting clinical-stage biotechnology company in Greater Boston, MA.
- Benefits: Hybrid work model, competitive salary, and opportunities for professional growth.
- Other info: Join a passionate team dedicated to innovation and patient care.
- Why this job: Make a real difference in patients' lives by shaping transformative therapies.
- Qualifications: 12+ years in regulatory affairs with strong interpersonal and negotiation skills.
The predicted salary is between 72000 - 108000 £ per year.
Senior Director, Regulatory Affairs – Permanent – Boston, MA
Proclinical is seeking a Senior Director, Regulatory Affairs for a growing and exciting clinical-stage biotechnology company based in the Greater Boston, MA Area.
Primary Responsibilities
In this role, you will help drive forward their regulatory strategy and operational activities related to the company’s muscle disease programs. The person in this role must thrive working in a fast-paced environment where flexibility, accountability and fearless innovation are key. Additionally, this individual must have excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic regulatory and strategies. A shared passion for the company’s mission to bring transformative therapies to people living with serious muscle diseases is a must.
The position is based in the Greater Boston, MA Area in a hybrid work environment.
Skills & Requirements
- Minimum of a bachelor\'s degree in life science or related discipline is required
- Minimum of 12 years of experience in regulatory strategy in a clinical-stage biotechnology company
- Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements
- Experience in Health Authority Meetings
- Knowledge of EU and international regulations related to the clinical, nonclinical, and CMC development a plus
The Senior Director, Regulatory Affairs will
- Interact with other departments to develop regulatory strategy and submission plans for quality and timely filings.
- As a member of program teams, provide global regulatory guidance regarding requirements for clinical development and registration of pharmaceuticals.
- Oversee preparation, review and submission of regulatory documents maintaining compliance with regulatory requirements.
- Manage timelines and preparation of meeting requests and briefing documents.
- Author/edit documents to support regulatory submissions.
- Compile, review, approve and submit clinical trial and marketing registration applications, amendments, and supplements.
- Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
- Support the organization with health authority meetings.
- Provide strategic guidance for and author applications related to expedited programs/ designations for rare muscle disease (e.g. Fast Track, Orphan Drug Designation, etc.).
If you are having difficulty in applying or if you have any questions, please contact Phu Huynh at (+1) 646-779-7961 or p.huynh@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
Seniority level
- Director
Employment type
- Full-time
Job function
- Science
- Industries Biotech Research and Pharmaceutical Manufacturing
Senior Director Regulatory Affairs in Boston employer: Proclinical Staffing
Proclinical Staffing is an excellent employer, offering a dynamic work environment in Barnard Castle where innovation meets quality. Employees benefit from a strong focus on professional development, with opportunities for growth within the quality control team, while enjoying a collaborative culture that prioritises adherence to GMP standards and excellence in microbiological testing.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Director Regulatory Affairs in Boston
✨Tip Number 1
Network like a pro! Reach out to your connections in the biotech field, especially those who have experience in regulatory affairs. 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 EU and international regulations. Be ready to discuss how your experience aligns with the company's mission to tackle muscle diseases. Show them you’re not just a fit for the role, but also for their vision!
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, send a quick thank-you note to express your appreciation. It keeps you fresh in their minds and shows your enthusiasm for the position.
✨Tip Number 4
Apply through our website for a smoother process! It’s often easier to track your application and you might even get noticed quicker. Plus, we love seeing candidates who take that extra step!
We think you need these skills to ace Senior Director Regulatory Affairs in Boston
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter to highlight your experience in regulatory strategy, especially in clinical-stage biotech. We want to see how your skills align with our mission to tackle muscle diseases!
Showcase Your Interpersonal Skills:Since this role involves working with various stakeholders, don’t forget to mention your excellent interpersonal skills. Share examples of how you've built relationships and managed conflicts in previous roles – it’ll make you stand out!
Highlight Relevant Experience:We’re looking for someone with at least 12 years in regulatory affairs, so be sure to detail your experience with major regulatory submissions and health authority meetings. The more specific you are, the better!
Apply Through Our Website:We encourage you to apply directly through our website for a smoother application process. It’s the best way for us to receive your application and get you on our radar quickly!
How to prepare for a job interview at Proclinical Staffing
✨Know Your Regulatory Stuff
Make sure you brush up on the latest regulations and guidelines relevant to muscle disease therapies. Familiarise yourself with EU and international regulations, as well as any recent changes in the field. This will not only show your expertise but also your commitment to staying updated.
✨Showcase Your Interpersonal Skills
Since this role involves interacting with various departments and stakeholders, be prepared to discuss how you've successfully built relationships in the past. Share specific examples of how your excellent communication and negotiation skills have led to successful outcomes in previous roles.
✨Prepare for Scenario Questions
Expect questions that assess your ability to handle complex regulatory challenges. Think about past experiences where you had to analyse issues and develop strategies. Be ready to explain your thought process and the impact of your decisions on regulatory submissions.
✨Align with the Company’s Mission
Demonstrate your passion for bringing transformative therapies to patients with serious muscle diseases. Research the company’s mission and values, and be prepared to articulate how your personal goals align with theirs. This will show that you’re not just looking for a job, but are genuinely invested in their mission.
