What are the responsibilities and job description for the Global Regulatory Compliance Manager position at Arrowhead Pharmaceuticals?
Regulatory Affairs Opportunity
Arrowhead Pharmaceuticals is seeking an experienced Regulatory Affairs professional to support our global regulatory projects.
About Our Work:
We develop innovative medicines that address unmet medical needs by leveraging our proprietary RNAi technologies.
We aim to become a leader in the field of RNAi-based therapeutics and to address conditions in virtually any therapeutic area.
We have a promising pipeline of preclinical candidates and are committed to pursuing disease targets not addressable by small molecules and biologics.
We collaborate with global regulatory agencies to ensure compliance with all relevant regulatory requirements and guidelines.
The Job:
This role will prepare and submit regulatory filings, participate in Health Authority interactions, and collaborate with the global regulatory lead and regional regulatory affiliates.
Responsibilities:
- Prepare regulatory filings (e.g., IND, CTA/IMPD, annual reports/progress reports, briefing documents)
- Participate in Health Authority interactions
- Collaborate with the global regulatory lead and regional regulatory affiliates (and consultants) in preparation and submission of global marketing authorization applications
- Create and maintain submission project plans, content plans, and responsibility matrices to ensure consistency and completeness to standards for all regulatory submissions
- Communicate regulatory requirements and updates to internal stakeholders
- Provide regulatory support and guidance to various departments, programs, and teams
- Review technical documentation to ensure regulatory compliance and conformance with existing regulatory applications and approvals
Qualifications:
- Education equivalent to a BS or MS, plus 5 years of hands-on regulatory experience, or Education equivalent to a higher degree (PhD), plus 3 years of hands-on regulatory experience
- Knowledgeable in ICH and FDA guidelines relevant to device and combination product CMC aspects of product development
- Ability to manage complex projects and timelines in a collaborative matrix team environment
- Effective communication and negotiation skills
- Attention to detail and ability to work individually or in a team
