Director, Regulatory Affairs
Company: MaxCyte Inc
Location: Rockville
Posted on: October 3, 2024
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Job Description:
Description:The Director, Regulatory Affairs will head the
Regulatory function at MaxCyte. The Director, Regulatory Affairs
develops and implements regulatory compliance and strategies that
enable MaxCyte to meet business needs as well as safety, quality,
and regulatory requirements. Utilizes knowledge of regulatory
requirements and regulations to maintain current regulatory
filings; interpret, plan, and communicate requirements; and
maintain regulatory compliance to ensure governmental approvals are
obtained. Job Responsibilities:Researches and interprets
regulations, guidance's, and precedents to support
interdepartmental project teams in developing strategies, policies,
and procedures that ensure regulatory compliance with global
regulatory agenciesMaintains and updates existing Master Files in
various countriesCreates and implements effective regulatory
strategies to deliver an efficient and robust development
planPartners closely with Legal, Quality, Manufacturing,
Engineering, Business Development, Commercial, and other areas of
the organization to ensure timely and strategic submissionsSupports
projects and product teams to prioritize and identify issues that
may increase regulatory risks and propose strategies to address
such risks. Suggests solutions for regulatory concerns regarding
country specific regulations, guidelines, and precedentsDevelops
regulatory processes and procedures and implements best
practicesEffectively plans, organizes, and participates in meetings
with regulatory agencies Leads and or participates in
communications and meetings with various global Regulatory
Authorities to ensure the review and acceptance of master file and
development plans, the timely resolution of issues, and the
approval of client marketing applicationsIdentifies and diminishes
quality and regulatory risks in collaboration with other colleagues
and stakeholdersInterfaces with consultants, auditors, regulatory
advisors Assess impact of changing regulations on submission and
product development strategies and updates internal/external
stakeholders in a timely mannerComplies with all applicable
policies regarding health, safety, and the environment
Requirements:BS/BA in science or engineering field with at least
8-10 years of leadership experience and at least 8 years of
relevant regulatory experience within biologics drug development,
ideally in cell and gene therapy. Experience in life sciences tools
and enabling technologies preferredAdvanced degrees (MA/MS/Ph.D.)
preferredSolid understanding of global regulatory and legal
liability issues. Demonstrated knowledge of regulatory standards
and processes, predominantly in FDA-regulated environments Hands-on
experience in global DMF filings and complianceProven track record
of success in problem solving and developing risk-based solutions
Strong verbal and written communications skills and the ability to
convey complex regulatory requirements in a straightforward and
practical mannerDisplays good business acumen Proven track record
of success in problem solving and developing risk-based solutions
Experience working on cross-functional teams to driving change and
successful implementationUnderstands relevant industry trends and
regulatory developments and changesStrong written and oral
communication skills Builds and cultivates strong relationships
Compensation details: 210000-229000 Yearly
SalaryPI7f19516839de-25660-35682728
Keywords: MaxCyte Inc, Rockville , Director, Regulatory Affairs, Executive , Rockville, Maryland
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