Bristol Myers Squibb
SeniorManager,RegulatoryStrategy
“Senior Manager, Regulatory Strategy at Bristol Myers Squibb. Skills: Regulatory strategy development and implementation, Regulatory authority communication (PMDA/MHLW), Risk mitigation planning, New drug development input, Clinical study plan acceptance, JNDA/sJNDA filing leadership, Regulatory intelligence and strategic planning. Provide and implement optimal regulatory strategy to achieve business targets. Improve quality of communication with regulatory authorities (PMDA/MHLW)”
What You'll Achieve.
Achieve BMSKK business target; Ensure J-HAs accept clinical study plans; Ensure clinical studies are initiated as planned; Ensure proposed development plan is accepted by J-HA; Ensure query responses can be submitted within the deadlines; Ensure submitted responses are high-quality responses that will not provoke additional queries; Maximize value of asset through Orphan drug or Priority review designations; Complete JNDA/sJNDA filing as planned; Submit query responses in a timely manner without having impacts on application period; Achieve strategic and operational excellence across disease areas
Industry & Context.
Problem-solving ability; Identify and assess regulatory risks; Propose risk minimization or mitigation plans; Lead discussion with relevant personnel; Identify problems at an early stage during the JNDA/sJNDA review and lead the preparation of either resolutions or alternative plans; Negotiate and solve problems
Ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed (for field-based and remote-by-design roles)
What They're Looking For.
Must Have
Up-to-date regulatory knowledge required to do the job with high quality as described above, Knowledge & experience with new drug development work, General business communication skills, Presentation skills, Strategic thinking ability, Negotiation skills, Leadership skills, Problem-solving ability, Mentoring and facilitation skills
What You'll Do.
Provide and implement optimal regulatory strategy to achieve business targets
Improve quality of communication with regulatory authorities (PMDA/MHLW)
Provide mitigation plans for regulatory risks
Provide input from a regulatory perspective to new drug development plans
Contribute to ensure J-HAs accept clinical study plans
Decide on and prepare for J-HA interactions
Provide advice for query responses related to CTNs and/or PMDA consultation
Collaborate on regulatory strategy for early JNDA and approval
Propose and lead work for Orphan drug or Priority review designations
Propose and build consensus on probability of regulatory success for approval
Lead JNDA team to complete JNDA/sJNDA filing
Determine and prepare for pre-JNDA consultations
Manage teams to submit query responses in a timely manner
Identify problems during JNDA/sJNDA review and lead preparation of resolutions
Collaborate on JNDA/sJNDA review plans and progress
Identify and assess regulatory risks in JNDA review
Lead strategic planning of the regulatory department
Provide regulatory guidance
Lead regulatory intelligence
Contribute to formulation and improvement of regulatory-related processes
Develop and promote workplace culture
negotiate and solve problems
Play a role in implementation of company and organization policies
How You'll Work.
Team & Collaboration
Engage internal and external stakeholders to resolve and coordinate issues; Collaborate with GRL regarding regulatory strategy and review plans; Maintain good relationship and communication with all relevant GRL/Global team colleagues; Lead discussion with relevant personnel for risk mitigation plans
Communication Scope
General business communication skills; Presentation skills; Negotiation skills
Process & Methodology
Lead the JNDA team to complete the JNDA/sJNDA filing as planned, Manage teams in order to submit query responses in a timely manner
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