At BioMed Valley Discoveries, we hire talented and passionate scientists, directors, and managers who have a shared vision and commitment to improve the lives of patients with difficult-to-treat diseases.
Our people recognize and embrace their unique roles and opportunities for advancing science to benefit patients. BioMed Valley Discoveries offers a challenging and stimulating environment for team members to manage a wide range of activities, to have recognized responsibilities and accountabilities, and to further develop their talents and passions.
Our culture promotes learning and growth at all levels. We believe in encouraging creativity, sharing ideas, and gaining knowledge and inspiration through the work we do. Our model demands that team members operate cross-functionally, wearing many hats, in order to maintain our nimble and efficient approach. As a result, our dedicated and highly experienced colleagues are passionate about achieving excellence in all they do. Members of our team will be challenged and expected to challenge others.
We provide employees with a comprehensive and competitive benefits package that includes medical, dental, vision, Simple IRA retirement plan, life insurance, and a flexible spending accounts for health care and/or dependent care.
BioMed Valley Discoveries (BVD) is currently seeking a highly skilled Regulatory Affairs professional to support regulatory strategies and filings for our development stage activities.
The successful candidate will be patient-focused, creative, energetic, and with a track record demonstrating notable accomplishment. They will have experience that exemplifies competency in contributing to the appropriateness of the drug development path as well as to compliance with applicable regulation. A thorough understanding of preparation and execution of regulatory strategies is expected, as well as the ability to manage the submission and approval of applications for clinical trials and other related regulatory submissions. This role requires an individual whose talents/experience support their effective and efficient participation on, and leadership of, multi-disciplinary teams. With offices in Kansas City, MO, BVD operates in a “virtual” manner whereby a small team of seasoned professionals works with collaborators across dozens of organizations on pre-clinical and clinical efforts.
- Independently plan, execute and manage regulatory submissions for BVD programs in various phases of clinical development
- Contribute to the development and evaluation of regulatory strategies for projects
- Facilitate discussions with regulatory authorities regarding phase I and II development strategies
- Review and provide regulatory comments to quality, safety and efficacy or labeling related documents
- Contribute to the development of risk assessment pertaining to the quality, safety and efficacy documentation/data of investigational medicinal products related applications
- Ensure compliance with regulatory requirements
- Establish and maintain an internal and external auditing program
- Remain abreast of current trends/literature as related to all projects supported
- Establish world-class network of collaborators to advance BVD programs
- Effectively provide regulatory area expertise to cross-functional teams
- Demonstrate highest professional scientific and interpersonal standards
- Bachelor’s Degree in a Life Science or related discipline, advanced degree preferred
- 8+ years regulatory experience in biotech, pharmaceutical, or CRO industry with background in oncology preferred
- Understanding of GCP regulations, ICH guidelines and internal SOPs
- Solid working knowledge of drug development process
- Experience in regulatory submission and approval processes and ability to deal with complex CMC regulatory issues and requirements
- Accomplished in authoring, collating and submitting CMC documents
- Experience with the clinical trial phase of development
- Experience working with cross-functional project teams, including CROs
- Excellent written and oral communication skills
HOW TO APPLY
When an opportunity in which you are interested becomes available, please submit your resume or CV and a cover letter by email to: email@example.com. All submissions will be evaluated. Interviews will be conducted for those applicants who most strongly fit our needs. If you are not contacted for an interview, your resume will remain on file and active for one year. No phone calls please.