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Chief Of Regulatory Affairs Jobs

Director Of Regulatory Affairs
By Trebla Talent At Greater Chicago Area, United States
Strong knowledge of current drug development regulations and guidelines including ICH, FDA and EMA guidelines; NDA experience is required.
Minimum of 10 years of experience across Regulatory Affairs or another transferrable function in biotech/pharma
Both clinical and CMC experience is desired
Bachelor’s degree is required; advanced degree is preferred.
A passion for the psychedelic and mental health industry
Director/Senior Director of Regulatory Affairs
Assistant Director Of Regulatory Affairs
By NC Real Estate Commission At West Bend, NC, United States

Attorney needed to assist division director with supervisory and managerial responsibilities and to prosecute cases involving allegations of violations of Real Estate License Law and Commission ...

Director Of Regulatory Affairs
By Tabseer | تبصير At Dallas, TX, United States
-Thorough knowledge of relevant regulatory laws, guidelines, and industry standards in Products Certification and Inspection Activities.
-Excellent communication and negotiation skills to articulate regulatory requirements and advocate on behalf of Tabseer.
-Good relationship with top level of Saudi Regulators’ Management Team.
Job Title: Regulatory Affairs Manager
-Clarify any ambiguous regulatory points or requirements by engaging with regulators and coordinating with internal teams.
-Stay informed about changes in regulatory landscape and assess their impact on Tabseer's certification and inspection operations.
Director Of Regulatory Affairs
By Lumicity At United States
Experience with documentation and lifecycle management within the biotechnology industry preferred
Effectively communicate the regulatory strategy, risks mitigation, and overall plans to program teams and senior management
Knowledge of regulatory requirements across development stages
Manage filings of necessary regulatory documents and manage lead meetings with regulatory agencies and other reviewing bodies
Identify applicable regulatory requirements for conducting clinical trials
Manage and help negotiate the regulatory activities of contract research organizations, consultants, and contractors in the preparation of regulatory submissions
Manager Of Regulatory Affairs
By Connect Life Sciences At Washington DC-Baltimore Area, United States
Strong management and leadership skills; experience leading/managing a team/project and/or supervising staff preferred.
Works closely with project management to mitigate/resolve issues and/or deviations from target timelines.
Provides regulatory and project management support for projects as needed.
Superior organizational skills and customer service abilities.
Strong working knowledge of Microsoft office; experience with SharePoint a plus.
Supervises and manage Regulatory Team staff members, as assigned.
Director Of Regulatory Affairs
By Sterling-Hoffman Life Sciences At Richardson, TX, United States
2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
3) Recent experience in the nutraceuticals industry is strongly preferred
4) Preference will be given to candidates with recent experience in regulatory affairs
4) Help the Regulatory Affairs Team apply complex regulatory concepts to projects in an easy-to-understand manner
5) Understand the interrelationship between labeling, artwork, and product regulations
8) Maintain regulatory records and files
Director Of Regulatory Affairs - East
By Carter Maddox At United States
In coordination with functional groups, manage policy and filing priorities.
Able to manage consultants to assist where necessary.
Experience in the renewable energy sector.
Strong experience in the regulatory process at state and federal level with a proven track record.
Exceptional analytical skills in understanding policy impacts to energy development and pricing.
Advanced level of education in policy is preferred but not required.
Director Of Regulatory Affairs
By Hemab Therapeutics At Boston, MA, United States
Direct point of contact with health authorities, leads and manages Regulatory Agency meetings, in cooperation with outsourced vendors.
Bachelors degree in a scientific subject area coupled with sufficient industry experience. Advanced degree (e.g. MSc, PhD, PharmD, MD) preferred.
Keeps abreast of new developments and therapeutic innovations, including regulatory requirements related to gene therapy and associated science.
Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity, and adaptability.
Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.
Participates with influence in or leads departmental and cross-functional taskforces and initiatives.
Head Of Regulatory Affairs
By Life Science People At Torrance, CA, United States
Proven people management experience, with a track record of building and leading high-performing teams
Participate in the development and implementation of regulatory strategies to support product approvals, license maintenance, and lifecycle management
Collaborate with cross-functional teams to ensure that regulatory requirements are integrated into product development plans and timelines
Strong knowledge of FDA, EMA, and other global agencies' regulations related to CMC submissions for generics and NCEs
Excellent writing, communication, and interpersonal skills
Prepare and maintain CMC documentation for various applications, including NDAs, DMFs, CEPs, INDs, etc.
Director Of Regulatory Affairs (Cell Therapy)
By GQR Global Markets At San Francisco Bay Area, United States
Assist in organization and management of staff within the RA group, including coaching, career development and oversight of work, as required.
Depth Knowledge of GLP and GCP regulatory requirements in domestic and globally.
Manage all aspects of nonclinical and clinical regulatory strategy development for products (early- to late-stage/registration/post-market).
Prior experience with cell or gene therapies (preferred)
Prior experience in oncology drug development
10+ years working within the biotech/pharmaceutical industry. 8+ years of pharma and/or biotech regulatory CMC-experience.
Chief Of Regulatory Affairs
By Idea Evolver At Philadelphia, PA, United States
10+ years of experience in Regulatory and Quality management, preferably in the SaMD space. ACNU expertise is a huge bonus.
Overseeing CAPA, Change Management, Internal and External Audits, Management Review & Post-Market Surveillance needs.
Overseeing QA/RA team to provide support for ensuring company compliance with all applicable quality, regulatory, & statutory requirements.
Responsible for ensuring compliance to Design Control & SDLC process requirements at a project level.
Experience working with medium to large-sized businesses in a client-facing role.
Highly motivated, independent individual with strong organizational skills and a thorough attention to detail.