Director, Submission Management
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.
Leads and/or actively participates in cross-functional teams. Brings complex issues to resolution successfully. Maintains awareness of upcoming regulatory changes impacting existing practices, processes and systems and proposes strategy to address. Leads or contribute to improvement initiatives.
Collaborates with regulatory domain data stewards and process/data owners. Escalate recommendations on issues or changes to governance boards for decisions, as needed.
- Creates and monitors workflows that progress regulatory objectives and activities. Provides guidance to colleagues for efficient operation of regulatory processes enabled via BMS regulatory system(s).
- Functions as an expert on respective Regulatory assignment, e.g. electronic submissions. Guides and teaches associates to understand results and trends.
- Approve formatting and communication of data in internal or external communications.
Leads and/or actively participates in cross-functional sub teams and brings complex issues to resolution successfully.
- Ensures communication of compliance issues to appropriate stakeholders facilitates remediation and strives for continuous improvements.
- Maintains broad master-level knowledge of BMS implemented standards and conventions across R&D systems with respect to business uses and operations. Instructs working groups on rules, and data quality expectations.
- Maintains awareness of health authority evolution of standards content, regulatory trends and changes. Communicate impacts to existing practices and propose updates. Support data stewards in the evaluation of change impacts. Participates or leads PEARL teams, as needed.
- Ensure product teams and functional groups have appropriate GDM staff participation. As company, growth or portfolio changes impact workload, plan resource adjustments.
- Provides advice and mentoring on BMS policies and procedures related regulatory submissions.
- Keep apprised of issues escalated to IT or business governance. Ensure data quality and that metrics reports are assessed/ analyzed. Present recommendations and solution options to governance.
- Lead regular communication with end-users. Review and approve knowledge articles when needed. Lead user group sessions. Create an environment where others will try new approaches and learn from the results. Foster and champion improvements that give junior associates opportunities.
- Provide support for internal audits, HA meetings, HA inspections and corrective action plans as required. Instruct others on inspection preparation.
- With exposure to multiple country authorities and requirements, review/ approve implementation of work instructions and procedural documents. Review existing practices and propose updates based on changing regulations and trends.
- Actively participate in improvement initiatives and special projects. Be able to influence and create changes that drive efficient working practices. Develop and articulate business cases. Lead efforts when appropriate.
- Participate in system updates and releases by interacting with IT to recommend system enhancements and business requirements. Utilize in-depth knowledge of the integrations with R&D systems, the direction and frequency of data exchanged to ensure accuracy of content.
- BS in a relevant scientific or technical field and 8+ years of relevant regulatory submission experience. Minimum of 2 years work in Regulatory Affairs.
- Demonstrates experience and understanding of the procedures and decision-making process of the Health Authorities.
- Strong knowledge and experience with electronic submission standards and requirements such as eCTD, NeeS, SPL,
- Able to instruct others on navigating content of Investigational and Marketing Application structure.
- Firm, detailed knowledge and experience with computer systems in an R&D environment.
- Expertise in system electronic records regulations (FDA Part 11 compliance).
- Experience in dealing with internal customers and supervising external contractors.
- Easily capable with new software and procedures.
- Excellent command of English language, both written and oral. Strong presentation skills.