The SparX Group is an emerging biotech powerhouse best known for its multi-specific antibody and antibody drug conjugate (ADC) discovery platforms. With a mission to “Recover Human Immunity by Empowered Antibody Therapies”, SparX has leveraged artificial intelligence to drive its proprietary target mining engine, allowing identification of cellular targets which can best be leveraged for optimal and synergistic biological activity. This sophisticated target discovery platform is combined with an integrated multi-component SAILING™ antibody optimization system and four cutting-edge ADC technologies to markedly improve the success rate of empowered antibody drug development. In addition to the integrated antibody discovery platform, SparX has built in-house GMP facilities of significant capacity in both Chicago and China to produce clinical and commercial drug products, allowing its evolution into an integrated and independent biopharmaceutical company.
SparX is currently looking to fill the role of Director, Regulatory Affairs. The candidate selected for this role will work in the north suburb of Chicago, overseeing the Regulatory Affairs activities at SparX’s Mount Prospect biologics manufacturing facility.
Responsibilities include:
- Develop and implement regulatory strategies for new and existing products throughout their lifecycle, including those related to CMC, clinical, and non-clinical issues.
- Compile, write, review, and approve regulatory submissions (i.e., pre-IND, IND, NDA, supplements, annual reports, IND safety reports, study protocols, and study reports), ensuring high quality and compliance with global regulatory guidelines while meeting aggressive timelines.
- Interact with health authorities in US and globally.
- Co-ordinate and consult with cross functional areas regarding the content, review, and assembly of regulatory documentation, ensuring consistency, completeness, and adherence to standards for regulatory submissions.
- Provide regulatory representation on project teams and provide clear and consistent regulatory recommendations and guidance based on sound regulatory strategy.
- Apply up-to-date knowledge of regulatory and quality compliance requirements and communicate changes in regulatory information to project teams and management.
- Problem-solve issues to preserve original timelines; track progress while being accountable for regulatory deliverables.
- Collaborate with multiple departments including Process Development, Manufacturing, Clinical Affairs, and Medical Affairs to develop and implement effective regulatory strategies that compliment business development.
- Assess scientific data against regulatory requirements for registration.
- Maintain good regulatory archive processes as well as effective communication with the team.
- Develop and maintain regulatory SOPs, processes, procedures, and templates.
- Comply with all Corporate policies, rules, and regulations as set out and communicated by the company pursuant to good business practice.
- Focus on organizational excellence; Coach and develop staff with skills in operational, technical, and regulatory leadership to make good, timely decisions and achieve impactful outcomes.
- Perform other related duties as assigned by management.
Qualifications/Skills:
- Bachelor’s degree in relevant scientific discipline (chemistry, life sciences, or related pharmaceutical science) with at least 10 years of Regulatory Affairs related to the development of pharmaceuticals with a strong working knowledge of US FDA regulations and ICH guidelines.
- A minimum of 3 years in biologics regulatory environment is a must.
- Prior experience in working directly with key regulatory agencies.
- Prior experience with successful submission of IND/NDA/BLA.
- Comprehensive understanding of GMP, FDA, ICH/VICH regulations for Biologics manufacturing and sciences leading to approval of drugs.
- Strong written and verbal communication skills with efficient documentation skills; must be able to author regulatory documents.
- Proficiency with MS-Office Suite and experience with Project Management and Analytics tools.
- Effective collaboration skills with a teamwork-oriented mindset, excellent problem-solving, presentation and interpersonal skills with strong leadership abilities.
- Excellent business ethics and professionalism.
Preferred Qualifications:
- Prior leadership experience in regulatory affairs aspects of biologics drug manufacturing.
- Ability to lead and build effective teams.
- Ability to multi-task in a fast-paced atmosphere with multiple/changing priorities.
- Ability to anticipate and mitigate against future strategic issues & uncertainties.
- Extensive knowledge of global GxP and regulatory requirements as related to the drug development process.
- Possess strategic and working knowledge of the biologic product life cycle from pre-IND through BLA.
- A strong working knowledge of global regulations especially with FDA and NMPA is preferred.
- Flexible and able to adapt to company growth and evolving responsibilities.
Benefits:
The successful candidate will enjoy a competitive base salary and the opportunity to participate in incentive compensation programs of the SparX Group, along with other benefit package.
About SparX Group
SparX Biopharmaceutical Corp. is a research-based development-stage biopharmaceutical company, dedicated to the mission of “strengthening human immunity using robust antibody therapies” through the discovery and development of innovative immuno-oncology agents. Equipped with big data analytical techniques, such as machine learning algorithms, SparX extracts potential interactions from large volumes of complex multi-dimensional public information. Mechanistic pharmacological analyses coupled with in vitro and in vivo evaluations using the syngeneic, transgenic and humanized mouse models, enables SparX’s focus on developing novel or best-in-class therapeutics demonstrating substantial advantages over existing therapies.
Target discovery and validation has historically been the bottleneck in drug development. SparX combines its sophisticated target discovery platform with an integrated multi-component SAILING™ antibody optimization system and a cutting-edge bi-ADC technology to markedly improve the success rate of empowered antibody drug development. In addition to the integrated antibody discovery platform, SparX has built in-house cGMP facilities of significant capacity to produce clinical and commercial drug products, facilitating its evolution into an integrated and independent biopharmaceutical company.
EEOC Statement:
Sparx is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. Sparx is committed to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, marital status, sexual orientation, genetic information, uniform service member or veteran status, or any other characteristic protected by federal, state or local law. Further, Sparx complies with all applicable national, state, and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Sparx is an e-verify employer.
