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Executive Director, Clinical Regulatory Affairs Lead
2 months ago
About Arrowhead Pharmaceuticals
Arrowhead Pharmaceuticals is a clinical-stage biopharmaceutical company that develops innovative medicines to treat intractable diseases by silencing the genes that cause them. Our team of scientists and researchers is dedicated to bringing new therapies to patients in need.
Job Summary
We are seeking an experienced Executive Director, Clinical Regulatory Affairs to lead our Clinical Regulatory sub-team and provide global oversight, direction, and leadership for all clinical regulatory activities related to our pipeline products.
Key Responsibilities
- Provide clinical regulatory expertise and leadership to ensure the company builds credible and trustworthy relationships with health authorities.
- Interact with FDA and other international regulatory agencies as needed, on a proactive, independent, and frequent basis.
- Supervise, manage, and collaborate with external service vendors, contractors, and consultants as needed.
- Obtain, generate information, and documents to be submitted to regulatory authorities.
- Prepare effective planning timelines and liaise with team contributors for the preparation of required regulatory documents and submissions.
- Provide regulatory subject matter expertise during the review of documentation, protocols, and reports received.
- Review and interpret regulatory rules as they relate to company products and procedures.
- Take a leadership role in the development of regulatory functional infrastructure and business operations.
- Serve as backup to the Vice President, Regulatory Affairs on assigned core teams as needed.
- Handle various project budgets as assigned.
Requirements
- Minimum Bachelor of Science degree in a science-related field (with an advanced scientific degree preferred) and 10+ years of relevant experience in a regulated drug environment.
- In-depth understanding of regulations and guidelines governing all phases (pre-IND through post-approval) of drug development.
- Good understanding of global clinical regulatory requirements for clinical trials.
- Demonstrated track record of successful regulatory filings.
- Previous experience in leading a team to prepare for major regulatory agency interactions.
- Highly proficient in the functionality of MS Word, Adobe Acrobat, and PowerPoint.
Preferred Qualifications
- Experience with the electronic submission process.
What We Offer
Arrowhead Pharmaceuticals provides competitive salaries and an excellent benefit package.
Equal Employment Opportunity
Arrowhead Pharmaceuticals is an equal opportunity employer and welcomes applications from diverse candidates.
