Arrowhead Pharmaceuticals is a clinical stage, Nasdaq listed (ticker ARWR) company developing medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, our 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 specified gene, thereby affecting the production of a specific protein. Our RNAi-based therapeutics are at the leading edge with the potential to bring life changing treatments for patients.
Our Targeted RNAi Molecule (TRiMTM) platform utilizes ligand-mediated delivery and is designed to enable tissue-specific targeting while being structurally simple. The TRiM platform builds on more than a decade of work on targeted RNA delivery and offers several advantages including simplified manufacturing and reduced costs; multiple routes of administration; and potential for improved safety.
Our employees are nimble, science-driven, innovative professionals. A career at Arrowhead offers the opportunity to collaborate with top notch scientists to rapidly discover and develop RNAi-based therapeutics in a variety of indications to add to our growing pipeline.
The Senior Regulatory Affairs Manager is responsible for facilitating drug product development and global registration by contributing to the development and execution of regulatory strategies and effective regulatory agency interactions. He/she will provide tactical and strategic input into the development of assigned projects playing a key role on cross functional product development teams, issuing global strategic plans as appropriate and ensuring regulatory deliverables are met within agreed upon timelines.
The Senior Regulatory Affairs Manager will liaise with national regulatory agencies particularly US FDA, Canada HC and other agencies as required.
Key Duties and Responsibilities:
- Act as the primary day-to-day liaison with the Program, Clinical and Safety team responsible for regulatory submissions and contribute to the development of scientific responses to Agency submissions and responses to questions.
- Develop and implement regulatory strategies pertaining to specific projects to expedite the development, filing, and regulatory approval for new development products;
- Participate in product development meetings and discussions to support execution of regulatory strategy and compliance with regulatory requirements.
- Collaborate with CRO’s / partners to support clinical trial approval and site initiation;
- Provide strategic and tactical support for the timely preparation, editing and review of submissions in support of global and regional regulatory activities (e.g. IMPD development and submission, regulatory submissions, agency meeting preparations). Provide and maintain CTA/MA documentation (e.g. annual reports, amendments);
- Prepare and manage various submissions and scientific responses to regulatory authority questions ensuring adherence to national and international regulations and standards (e.g. FDA, Health Canada, European Union and Asia). Liaise with these regulatory agencies as required;
- Liaise with CMC regulatory lead as well as Manufacturing/CMC function on pharmaceutical documentation preparation, submission requirements and strategy;
- Liaise with the Program, Clinical and Safety team responsible for regulatory submissions and contribute to the development of scientific responses to Agency submissions and responses to questions;
- Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards and apply appropriate implementation strategies.
- Minimum of a Bachelor’s degree in Biochemistry, Chemistry, Biology, or related science discipline
- Minimum of 7 years of relevant experience in pharmaceutical drug development with at least 5 years in regulatory affairs in the development of novel molecular entities
- Demonstrable experience in successfully developing and managing regulatory submissions, review and preparation of scientific/technical/clinical responses to agency questions
- Exceptional organizational skills, ability to multi-task and be detail oriented
- Strong interpersonal and communication (both oral and written)
- Works well within diverse groups to achieve common goals
- Ability to maintain highest degree of professionalism, integrity and diplomacy
- Strong problem-solving skills and ability to deal with changing priorities
- Excellent project management skills
- Proficient in pertinent software & tools
- Technical writing experience
- MS or PhD. Masters in Regulatory Affairs or Regulatory Affairs Certification through the Regulatory Affairs Professional Society is desirable.
- Prior experience with the preparation of CTA/IND sections for regulatory submissions, as well as knowledgeable of ICH and FDA guidelines relevant to nonclinical, clinical and CMC aspects of product development
- Knowledgeable in industry trends for study reports and dossier preparation (e.g., IND/CTA/NDA/NDS), including electronic document submissions (i.e., eCTD)
Please submit a resume and cover letter to firstname.lastname@example.org.
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the U.S. for a company.