Senior Regulatory Affairs Associate
Reports to: Associate Director, Regulatory Strategy and Operations
X4 is focused on restoring healthy immune system function by developing novel therapeutics for the treatment of rare diseases.
Our first-in-class, oral, small molecule therapeutics are antagonists of chemokine receptor CXCR4, which have the potential to treat a broad range of rare diseases, including primary immunodeficiencies (PIs) and cancer. A number of PIs are attributed to the improper trafficking of immune cells related to the CXCR4 receptor and its ligand CXCL12.
X4 Pharmaceutical’s lead product candidate, mavorixafor (X4P-001), is a potentially first-in-class, once-daily, oral inhibitor of CXCR4, currently in Phase 3 development for the treatment of WHIM syndrome, a rare, inherited, primary immunodeficiency disease caused by genetic mutations in the CXCR4 receptor gene. Mavorixafor has demonstrated proof of concept in WHIM in a Phase 2 trial, including clinically meaningful increases in neutrophil and lymphocyte biomarker counts, as well as a trend of reduction in infection rates and wart burden, and a favorable safety profile. A Phase 2 open label extension study for WHIM is ongoing. Mavorixafor was designated orphan drug status by the U.S. Food and Drug Administration in 2018 for the treatment of WHIM and is also in development for Severe Congenital Neutropenia (SCN), Waldenström’s macroglobulinemia (WM), and clear cell renal cell carcinoma (ccRCC).
X4 is also developing X4P-002, a CXCR4 antagonist that has unique properties that the company believes will enable penetration of the blood-brain barrier and provide appropriate therapeutic exposures to treat brain cancers, including glioblastoma multiforme (GBM).
Reporting to the Associate Director, Regulatory Strategy and Operations, the Senior Regulatory Affairs Associate will be responsible for daily operations activities for global regulatory submissions across both the oncology and rare disease indications. The Senior Regulatory Affairs Associate will work collaboratively with the Regulatory Affairs team along with the Cross Functional teams to manage all aspects of the submission, from authoring documents to final submission of documents to global health authorities, utilizing an external publishing vendor.
To succeed at X4, the candidate will have a sustained reputation for putting the patient first and foremost, as well as a values-driven work style where integrity and grit drive all behaviors, decisions and actions.
This position is located in Cambridge, MA and does not include a relocation package. Qualified out- of- state applicants are responsible for their relocation.
Scope of Work and Responsibilities:
- Responsible for the day to day regulatory operations function working with the development teams to plan, develop, compile and publish submissions in accordance with regional requirements throughout the product life cycle for all indications.
- Collaborate and develop strong relationships with external vendors to formally publish all submissions via eCTD or other methods, as appropriate with health authority requirements, to ensure on time delivery of submissions.
- Responsible for preparing accurate safety reporting submissions and ensuring all global safety requirements are met.
- Proactively perform quality checks on all documents throughout drafting up until final submission to health agencies.
- Maintain global regulatory files and chronologies to ensure chronologies remain in good order; formal submissions and other correspondences.
- Collaborate with functional leads to ensure all submission documents are compliant with regulatory and company guidance/template specifications.
- Create and drive timelines ensuring tracking deliverable's are met against deadlines.
- Proactively anticipate and communicate any potential risks identified that may derail timelines and propose risk mitigation strategies and execute, as needed.
- Attend Cross Functional Team meetings to communicate timelines related to submission contents to ensure timely transmission to appropriate health authorities.
- Track regulatory submission activities and provide forward looking submission planning for ongoing programs.
- Author study transfer of regulatory obligations (TOROs) documents annually and lead team review/updates.
- Facilitate the review of technical regulatory documentation and recommend changes to documentation or processes, including SOPs for regulatory compliance.
- Regulatory representative for applicable clinical and regulatory study meetings and assist in compiling documentation to support clinical, regulatory and pharmacovigilance operations.
- Work with Regulatory Affairs supervisors to define regulatory strategy.
- Review new regulatory guidance’s/issues, disseminate information and evaluate the potential impact on projects and timelines.
- Assist with various projects as needed.
- Provide support to senior Regulatory Affairs staff and management as needed.
Qualifications and Professional Skills:
- Bachelor’s degree in Life Sciences or Healthcare discipline.
- 2+ years of relevant Regulatory Affairs experience working in a biotechnology or pharmaceutical environment managing various submissions.
- Advanced expertise using Microsoft Office Suite (Outlook, Word, PowerPoint, Excel, SharePoint), Adobe Acrobat Professional, and eCTD content templates (e.g., Starting Point).
- Maintain current knowledge of international regulations, guidance and standards applicable to X4 products.
- General understanding of the drug development process.
- Ability to manage multiple projects in a fast- paced environment with the ability to adapt to moving deadlines and priorities.
- Motivated, highly detail oriented, self-starter with the ability to work autonomously and in a multilevel, cross functional team setting to achieve company goals.
- Excellent interpersonal and intercultural communication skills, both written and verbal.
- Strong software troubleshooting skills highly desirable.
- Experience working with external publishing vendors desired.
The above statements are intended to describe the general nature and level of work being performed. They are not intended to be construed as an exhaustive list of all responsibilities.
X4 Pharmaceuticals is an Equal Opportunity and Affirmative Action Employer committed to a culturally diverse workforce. All qualified candidates will receive consideration without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital, domestic partnership or civil union status, sex, gender identity or expression, sexual orientation, disability, veteran status, violence victim status or any other characteristic protected by law.
Job Type: Full-time
- 401(k) Matching
- Dental Insurance
- Employee Discount
- Flexible Spending Account
- Health Insurance
- Paid Time Off
- Referral Program
- Retirement Plan
- Vision Insurance
- Regulatory Affairs: 2 years (Required)
This Company Describes Its Culture as:
- Detail-oriented -- quality and precision-focused
- People-oriented -- supportive and fairness-focused
- Team-oriented -- cooperative and collaborative