Associate/Sr. Regulatory Affairs Associate

Arrowhead Pharmaceuticals, Inc; Pasadena (CA); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a detail-oriented Associate/Sr. Regulatory Affairs Associate to drive regulatory operations and ensure compliance with stringent standards. This role involves managing regulatory documentation, collaborating with various teams, and staying updated on FDA and international regulations. The ideal candidate will possess strong organizational skills and a commitment to quality, contributing to the success of innovative therapies that address intractable diseases. Join a dynamic team where your efforts will play a crucial role in advancing groundbreaking biopharmaceutical solutions.

Qualifications

• 1+ years of experience in pharmaceutical drug development required.
• Bachelor's in biochemistry, chemistry, or biology preferred.

Responsibilities

• Manage regulatory documents and submissions for compliance.
• Collaborate with internal and external groups for timely submissions.

Skills

Regulatory Compliance

Organizational Skills

Interpersonal Communication

Attention to Detail

Quality Commitment

Education

Bachelor’s degree in Science

Masters in Regulatory Affairs

Tools

Veeva Vault

Microsoft Office

Adobe Acrobat

Job description

Associate/Sr. Regulatory Affairs Associate

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes.

The Position

The Associate/Senior Regulatory Affairs Associate will play a key role in Regulatory Operations, focusing on the collection, preparation, and management of regulatory documents and submissions activities. This includes maintaining the regulatory archive by developing its structure, obtaining, tracking, and securely storing documents and files. The role requires close collaboration with internal/external groups to ensure timely and accurate submission documentation while providing regulatory support and guidance to the R&D product development teams in related technical functions. Additionally, the Associate/Senior Regulatory Affairs Associate will ensure all regulatory requirements and compliance standards are met throughout the document development and submission process.

Responsibilities

• Develop and maintain comprehensive tracking logs (both paper and electronic), for all global regulatory correspondence and interactions to projects and products with Health Authorities.
• Collect, organize, and prepare regulatory documentation for submission to regulatory agencies, including FDA, Health Canada, EMA, and others, as well as provide strategic advice on submission planning.
• Collaborate with external CROs/vendors to facilitate the efficient transfer of clinical trial regulatory submission documents and completed FDA Agency electronic submission documents to electronic document system (i.e., Veeva Vault).
• Develop and manage electronic document system tools, including dashboard and reports, in Veeva Vault to enhance submission transparency and streamline efficiency.
• Monitor and track regulatory activities, update metadata and attributes in Veeva Vault regularly, and ensure all submission records are accurate, complete, and up to date.
• Stay up to date with FDA and international regulations, guidance, and standards applicable to company’s products.
• Research regulatory issues, share relevant updates with product and technical teams as well as senior management as needed.
• Provide functional area support for specific projects as requested, ensuring alignment with regulatory requirements.
• Ensure compliance with company’s retention and destruction policy.
• Assist in developing SOPs and Work Instructions to enhance regulatory compliance.
• Actively participate in assessing the quality and regulatory compliance of changes to document/product/process/test method changes.

Requirements:

• Bachelor’s degree in Science discipline is required- biochemistry, chemistry, or biology is preferred.
• Work Experience: minimum of 1 year of relevant experience in pharmaceutical drug development.
• General understanding of pharmaceutical development, clinical research, and the regulatory environment.
• Knowledgeable in the preparation of GxP documentation is essential.
• Exceptional organizational skills, ability to multi-task and be detail-oriented.
• Strong interpersonal communication skills, both written and verbal.
• Strong commitment to quality.
• Ability to work independently and drive work projects to completion.
• Microsoft Windows, Microsoft Office- Word, Excel, PowerPoint.
• Publishing tools- Adobe Acrobat, ISI Toolbox, Compose.

Preferred:

• Masters in Regulatory Affairs or Regulatory Affairs Certification through the Regulatory Affairs Professional Society.
• Experience with electronic document submissions (i.e., CTD).

Arrowhead provides competitive salaries and an excellent benefit package.

All applicants must have authorization to work in the US for a company.