Associate/Sr. Regulatory Affairs Associate

Arrowhead Pharmaceuticals; Pasadena (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

An established industry player in the biopharmaceutical sector is seeking an Associate/Sr. Regulatory Affairs Associate to join their innovative team. This role is pivotal in managing regulatory documents and submissions, ensuring compliance with industry standards. The successful candidate will collaborate closely with R&D teams and external partners, leveraging their expertise in regulatory affairs to streamline processes and enhance submission transparency. If you have a passion for science and a commitment to quality, this opportunity offers a chance to make a significant impact in developing groundbreaking therapies for patients in need.

Benefits

Competitive Salaries

Excellent Benefit Package

Qualifications

• 1+ years of experience in pharmaceutical drug development required.
• Strong understanding of regulatory environment and GxP documentation.

Responsibilities

• Develop and maintain tracking logs for global regulatory correspondence.
• Prepare regulatory documentation for submission to agencies like FDA.
• Collaborate with CROs to facilitate clinical trial document transfers.

Skills

Regulatory Affairs

Documentation Management

Interpersonal Communication

Organizational Skills

Quality Assurance

Education

Bachelor's degree in Science

Master's in Regulatory Affairs

Tools

Veeva Vault

Microsoft Office

Adobe Acrobat

SharePoint

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. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.

Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.

Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI and San Diego, CA. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.

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 of 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 years of relevant experience in pharmaceutical drug development.
• Experience in developing and managing technical documentation.
• Experience with Electronic Document Management Systems for record management.
• 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.
• Good Proficiency:
• Veeva Vault (e.g., Veeva RIM).
• Microsoft Windows, Microsoft Office- Word, Excel, PowerPoint.
• Internet based SharePoint files.
• Publishing tools- Adobe Acrobat, ISI Toolbox, Compose.
• Scanning and Maintenance of electronic records.

Preferred:

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

California pay range:
$90,000—$120,000 USD
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.