Senior Manager, Global Regulatory Strategy, Neurosciences

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

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 with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

Position Responsibilities

• In close partnership with the regional strategists / liaisons and/or GRL Team leader, develop strategic and operational plan for the development and the registration of assets across Therapy Area.
• Lead development of strategy and content for US dossier in partnership with marketing application submission teams for indications that are at the regulatory filing stage;
• Develop contingency plans in conjunction with the GRL or Team Leader for achieving regulatory objectives with associated risks and mitigation strategies in conjunction with GRT
• Develop and execute approaches to resolve regulatory issues and appropriately drive speed to patients.
• Develop predictions for expectations and risks associated with outcomes by regulatory agencies, identifies regulatory risks and proposes mitigations to senior leaders and cross-functional teams.
• Lead and/or support global health authority interactions by preparing objectives for meetings, outline of briefing material, facilitating content discussions and input. Contribute to building a strong and trusted relationship with Health Authorities.
• Lead preparation of, and contribute to, the content of responses to queries from HAs for respective regions/countries
• Provide input to key development documents, including clinical protocols, clinical and nonclinical reports and summary documents, statistical analysis plans, DMC charters, IBs, DSURs; (US Regulatory documents such as BTD, ODD, iPSP) etc.
• Lead assessment of regulatory precedence and regulatory scientific guidelines. Lead identification and compilation of regulatory lessons learned, bringing the appropriate regulatory and clinical experts together, e.g., registrational program precedents, integrated summaries of EPARs and SBOA, main messages from a competitor Ad Com. Use and share learnings and best practices.
• Track schedules and attendance of relevant Public-Private regulatory meetings or FDA workshops.
• Contribute to one regulatory voice to key stakeholders internally and externally (operational partners, health authorities).

Degree Requirements

• Scientific background, Ph.D., M.D., PharmD, MS or BS, or equivalent professional experience

Experience Requirements

• min 2 to 8 years years of relevant regulatory experience are required depending on the type of experience and scientific background.

Key Competency Requirements

• Experience in Neuroscience would be a plus
• An adequate knowledge of (i) drug development and (ii) policy, laws, regulations and guidelines as they apply to the FDA for drug development and approval is required.
• Good interpersonal skills: willingness to leverage strengths of the team and cooperate with peers within a cross-functional environment.
• Proven ability to work with outside partners. Ability to understand scientific content.
• Demonstrated ability to be solution-oriented
• Seeks multiple perspectives and listens openly to others’ points of views.
• Enables and demonstrates the courage to speak up on issues and risks as well as on the good news.
• Demonstrates ownership of results within (and beyond) area of responsibility.
• Sets clear and high expectations and holds self and others accountable for decisions and results achieved.
• Looks for opportunities for continuous improvement.

Travel

Occasional, domestic

**French version Responsabilités du poste

• En partenariat avec les équipes de soumission de demandes d’enregistrement, mener l'élaboration de la stratégie et du contenu pour le développement et l’enregistrement de nouveaux produits, essentiellement aux Etats-Unis.
• Développer des plans de contingence en collaboration avec le GRL ou le chef d'équipe afin d'atteindre les objectifs réglementaires, en identifiant les risques associés et les solutions en concertation avec la GRT.
• Développer et mettre en œuvre des approches pour résoudre les problèmes réglementaires et favoriser efficacement l'accès rapide aux patients.
• Prévoir les attentes et les risques liés aux décisions des agences réglementaires ; identifier les risques réglementaires et proposer des solutions au management et aux équipes interfonctionnelles.
• Diriger et/ou soutenir les interactions avec les agences réglementaires en préparant les objectifs des réunions, les grandes lignes des documents d'information, at en contribuant à leurs contenus. Contribuer à l'établissement de relations solides et de confiance avec les autorités de santé.
• Diriger la préparation et contribuer au contenu des réponses aux questions des autorités sanitaires pour les régions/pays respectifs.
• Contribuer aux principaux documents de dévelopement, notamment les protocoles cliniques, les rapports cliniques et non cliniques, les documents de synthèse, les plans d'analyse statistique, les chartes des DMC, les BI, les DSUR ; ainsi que les documents réglementaires américains tels que BTD, ODD, iPSP, etc.
• Diriger l'évaluation des précédents réglementaires et des lignes directrices scientifiques réglementaires. Diriger l'identification et la compilation des expériences réglementaires, en réunissant les experts réglementaires et cliniques appropriés, par exemple : les précédents des programmes d'enregistrement, les synthèses des EPAR et SBOA, les principaux messages issus de FDA Advisory Committees. Utiliser et partager les expériences communes.
• Suivre les calendriers et la participation aux réunions public-privé ou à celles des autorités réglementaires.
• Contribuer à une voix réglementaire unique auprès des parties prenantes internes et externes (partenaires opérationnels, autorités de santé).
• Diriger l'élaboration de la stratégie et du contenu pour les dossiers Américains, en partenariat avec les équipes de soumission d’AMM.

Exigences en matière de diplôme

• Formation scientifique : Ph.D., M.D., PharmD, M.Sc. ou B.Sc., ou expérience professionnelle équivalente.

Expérience et Compétences requises

• De deux à huit ans d'expérience réglementaire pertinente sont requis, selon le type d'expérience et la formation scientifique.
• Une connaissance adéquate (i) du développement des médicaments et (ii) des politiques, lois, réglementations et directives applicables à la FDA pour le développement et l'approbation des médicaments est requise.
• Bonnes aptitudes interpersonnelles : volonté de tirer parti des forces de l'équipe et de coopérer avec les pairs dans un environnement interfonctionnel.
• Capacité avérée à travailler avec des partenaires externes.
• Capacité à comprendre le contenu scientifique.
• Capacité démontrée à proposer des solutions.
• Ouvert(e) aux perspectives multiples et à l’écoute des points de vue des autres.
• Fait preuve du courage d'exprimer ses opinions sur les problèmes et les risques, ainsi que concernant les succès.

Déplacements

Occasionnels, Amerique du Nord

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Aperçu de la rémunération :

• Montreal
• QC - CA: $130,820 - $158,517

La plage de rémunération de départ pour ce poste est indiquée ci-dessus sur la base d’un emploi à temps plein (FTE). Des primes en espèces et des attributions d’actions supplémentaires (selon l’admissibilité) peuvent également être offertes. La rémunération initiale tient compte des caractéristiques du poste, telles que les compétences requises, le lieu de travail, l’horaire de travail, ainsi que les connaissances et l’expérience liées à l’emploi. La rémunération finale sera déterminée en fonction de l’expérience démontrée et conformément aux principes d’équité salariale et aux lois applicables en matière d’emploi.

Compensation Overview:

• Montreal
• QC - CA: $130,820 - $158,517

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. The final compensation will be determined based on demonstrated experience and in accordance with pay equity principles and applicable employment laws.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1603026 : Senior Manager, Global Regulatory Strategy, Neurosciences