Associate Director/Director of Regulatory Affairs - 229551
Medix™
Rockville, MD
See who Medix™ has hired for this role
Key Responsibilities:
- Collaborate with cross-functional teams to develop and implement regulatory strategies, manage regulatory risks, and ensure compliance with current regulations for cell therapy products.
- Prepare and manage regulatory submissions (INDs, CTAs, BLAs/MAAs) to agencies like the FDA and EMA.
- Ensure quality and accuracy of regulatory submissions, adhering to timelines and requirements.
- Supervise CROs/vendors handling regulatory submissions.
- Integrate Health Authority feedback into global nonclinical and clinical development strategies.
- Assist in planning and preparing clinical and non-clinical strategies for global HA meetings.
- Review and provide feedback on company-sponsored abstracts, manuscripts, and publications.
Qualifications:
- Bachelor's degree in life sciences or related field (advanced degree preferred).
- 7-10 years of regulatory affairs experience in biopharmaceuticals or cell therapy.
- Knowledge of US FDA and international pharmaceutical regulations, drug development processes, and industry practices.
- Experience with early-stage development and marketed products preferred.
- Familiarity with GXPs and regulatory submission requirements in ICH regions.
- Preferred experience in hematology, blood coagulation, or platelet cell biology.
- Experience in biotech or startup settings preferred.
- Strong communication, negotiation, and leadership skills.
-
Seniority level
Director -
Employment type
Full-time -
Job function
Science and Research -
Industries
Biotechnology Research and Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Medix™ by 2x
See who you knowGet notified about new Regulatory Associate jobs in Rockville, MD.
Sign in to create job alertSimilar jobs
-
VP of Legal
VP of Legal
Devonshire
-
Chief Legal Officer - SHCLO
Chief Legal Officer - SHCLO
Leap Brands
-
Legal Director
Legal Director
Marble Law
-
Director of Law Firm Operations
Director of Law Firm Operations
Michigan Law Center
-
VP of Legal, Commercial & Entertainment
VP of Legal, Commercial & Entertainment
Condé Nast
-
Head of Legal Affairs
Head of Legal Affairs
Augment Jobs
-
Senior Vice President, Chief General Counsel
Senior Vice President, Chief General Counsel
IDEAYA Biosciences
-
Chief Legal Officer
Chief Legal Officer
Tapio
-
Vice President, Legal
Vice President, Legal
Apeel
-
Head of Legal
Head of Legal
ePayPolicy
-
Head of Legal
Head of Legal
Constructor
-
Head of Legal
Head of Legal
PharmaEssentia
-
SVP/VP, Global Head of Regulatory Affairs | Confidential Retained Search
SVP/VP, Global Head of Regulatory Affairs | Confidential Retained Search
Cornerstone Search Group
-
Vice President, General Counsel
Vice President, General Counsel
The PeterSan Group and PeterSan Legal Staffing
-
Vice President of Legal & Compliance Officer
Vice President of Legal & Compliance Officer
Iodine Software
-
SVP, Legal and Business Affairs
SVP, Legal and Business Affairs
Sony Music Entertainment
-
Director - Legal Affairs
Director - Legal Affairs
Rose International
-
Chief Legal Officer
Chief Legal Officer
HomeFront Brands
-
Head of Global Contract Compliance
Head of Global Contract Compliance
DoiT International
-
Head of Global Contract Compliance
Head of Global Contract Compliance
DoiT International
-
Chief Legal Officer
Chief Legal Officer
Bookman Consulting
-
Senior Director, Corporate Law and Governance
Senior Director, Corporate Law and Governance
GEICO
-
Head of Global Contract Compliance
Head of Global Contract Compliance
DoiT International
-
Head of Global Contract Compliance
Head of Global Contract Compliance
DoiT International
-
Head of Global Contract Compliance
Head of Global Contract Compliance
DoiT International
People also viewed
-
Senior Director, Legal
Senior Director, Legal
-
Director - Legal Affairs
Director - Legal Affairs
-
Head of Global Contract Compliance
Head of Global Contract Compliance
-
VP Legal & Compliance
VP Legal & Compliance
-
Head of Global Contract Compliance
Head of Global Contract Compliance
Looking for a job?
Visit the Career Advice Hub to see tips on interviewing and resume writing.
View Career Advice Hub