Global Director - Regulatory Affairs

April 3

🍂 Massachusetts – Remote

Although this job is listed in Massachusetts, this company may be open to hiring remote in other states.

🔔 Pennsylvania – Remote

Although this job is listed in Pennsylvania, this company may be open to hiring remote in other states.

+2 more states

🍂 Massachusetts – Remote 🔔 Pennsylvania – Remote 🌴 South Carolina – Remote 🤠 Texas – Remote

⏰ Full Time

🔴 Lead

🚔 Compliance

Apply Now

Receive Emails with Similar Jobs

RemeGen Biosciences

WebsiteLinkedInAll Job Openings

RemeGen Biosciences is creating innovative medicines to serve patients suffering from serious illnesses. The company is committed to the discovery and development of innovative and differentiated therapeutics, striving to create value through delivering medicines for the treatment of diseases with unmet medical needs.

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• RemeGen Biosciences is a biopharmaceutical company focused on innovative medicines. • The Director will oversee regulatory strategies for product registrations in international markets. • This role provides regulatory guidance, ensuring compliance with international regulations. • Responsibilities include managing interactions with regulatory agencies and project submissions. • The position is remote for candidates located in specified states.

🎯 Requirements

• Education: BS in a science related field, required. • Advanced training in medical or life sciences is a plus. • Experience: 10+ years of relevant regulatory/industry experience in both biotech or pharmaceuticals. • At least 8 years as the Global Regulatory Affairs lead representative on project development teams that have led to marketing authorization. • Must have experience supporting clinical development teams in the autoimmune space. • Scientific, technical, and developmental background in large molecular drug development is highly desired. • Experience from IND through to BLA, across all disciplines (nonclinical, clinical, CMC), as well as attending/running regulatory interactions. • Skills: Knowledge and understanding of autoimmune disease biology and translational research is required. • Recognize concept of “one registration” and recognize the differences in responsibilities between Headquarters and local teams. • Excellent written and verbal communication skills. • Ability to work cross-functionally in a fast-paced, collaborative environment. • Strong attention to detail and problem-solving skills.

🏖️ Benefits

• 401(k) and matching program • Medical, Vision, and Dental Insurance • Flexible Spending Account • Short- and long-term disability • Life insurance • Employee Assistance Program • Employee discounts • Paid time off/vacation/sick time • Professional development assistance • Referral program