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Bristol Myers Squibb: Director, Global Regulatory Strategy And Policy

Bristol Myers Squibb

This is a Full-time position in Summit, NJ posted October 12, 2021.

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science.

In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change.

We bring a human touch to every treatment we pioneer.

Join us and make a difference.

POSITIONDirectorFRANCHISECell TherapyFUNCTIONGlobal Regulatory Strategy and PolicySUPERVISORHead of Regulatory Cell Therapy Therapeutic AreaPREREQUISITESBachelors degree.

Advanced degree preferred; Minimum of 15 years pharmaceutical industry experience with a minimum of 10 years in regulatory affairs leading strategy development and implementation in a cross-functional project team setting.

Regulatory experience in multiple phases of drug development across various disease areas, with expertise in Hematology/Oncology diseases and Cellular Therapies required; Demonstrated leadershipin mentoring, building successful goal-oriented teams and supervising staff.

Prior supervisory experience preferred.

Responsibilities will include, but are not limited to, the following:Accountable for the development and implementation of innovative global regulatory strategies within a team, disease or program to maximize the likelihood of regulatory success.Accountable for the planning and execution of submission strategy for major regulatory dossiers.Accountable for conducting regulatory risk planning and mitigationAccountable for maintenance of existing product portfolio and for life cycle management to ensure alignment with corporate objectivesAccountable for resource planning and implementation consistent with strategic priorities, as appropriate.Provide information from regulatory team to support planning and maintaining the regulatory budgetRepresents Regulatory Affairs as a collaborative partner to provide strategic regulatory guidanceRepresents Regulatory Affairs on Disease Strategy TeamA member of the Hematology/Oncology Regulatory Leadership TeamRepresent Regulatory Affairs at corporate governance committees, as appropriate, providing strategic advice to senior management throughout the development of a product.Represent Regulatory Affairs on due diligence activities and alliance management partnership programsParticipate in or lead internal cross-functional initiativesParticipate in or lead industry initiatives (eg, workshops, symposia etc)Maintain oversight of, or participates in key interactions with health authorities and communicate health authority feedback as appropriate to Regulatory Leadership TeamMaintain oversight of the development and maintenance of internal Global Regulatory Affairs practices and proceduresMaintain knowledge of global competitive landscape, regulatory environment, regulations and guidance.Maintain knowledge of the disease areas through regulatory intelligence, KOL interface etc; interpret and impart this knowledge within the disease areas and to stakeholdersSupports Celgene priorities in Regulatory Policy, intelligence and ScienceLead, mentor and guide development of talent within the team, which includes succession and development planning, performance management, and recognition Key Requirements/Knowledge:Bachelor’s degree; Advanced degree preferredMinimum of 15 years pharmaceutical industry experience with a minimum of 10 years in regulatory affairs leading strategy development and strategy implementation in a cross-functional project team settingRegulatory experience and knowledge in multiple phases of drug development across various therapeutic areas, with expertise in Hematology/Oncology diseases and Cellular Therapies requiredDemonstrated experience in strategic planning, preparing and leading global dossier submissions (eg, US, EU, etc)In depth knowledge of current global regulations and guidance (eg, US, EU, ICH, etc) essential as they relate to the overall global regulatory strategyExcellent organizational, writing, communication and time management skills needed to manage multiple ongoing projects simultaneouslyDemonstrated ability and credibility to anticipate, analyze and resolve complex global regulatory related problems and ability to cope with ambiguityDemonstrated management experience with direct report and in-direct report supervisionDemonstrated ability to effectively lead, coach and mentor colleaguesAnticipate future needs within the function when selecting and developing talent (eg, develops successors and talent pools for key positions)Domestic and occasional International travel is required Competencies /SkillsResults driven and team-orientated with the ability to influence outcomes as necessary skills in the environmentDemonstrated ability to use scientific and clinical knowledge to conceptualize study designsProficiency in data interpretationDisplay a willingness to challenge the status quo and take risks through innovationCultivates internal and external networks of people across a variety of functions and locationsAble to develop and actively use external relationships with key stakeholders to reinforce Celgene’s regulatory credibilityExcellent skills in oral and written communication, including effective presentation skills to clearly articulates ideas, opinions and informationExcellent interpersonal skills and ability to communicate effectively across Global Regulatory Affairs and across the different organization functionsGood listening skills and a strong willingness/desire to help resolve issues faced by others around them Celgene Leadership CompetenciesDrive Innovation and ResultsShape StrategyAttract and Develop TalentPromote Open CommunicationCreate Global MindsetDemonstrate AdaptabilityFoster Risk TakingFoster TeamworkPassion for the PatientAround the world, we are passionate about making an impact on the lives of patients with serious diseases.

Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S.

and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation.

Therefore, all BMS applicants seeking a role located in the U.S.

and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment.

This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana.

This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles.

Applicants can request an approval of accommodation prior to accepting a job offer.

If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S.

or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com.

Visit careers.Bms.Com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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