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Senior Director Regulatory Affairs Jobs

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.
Senior Regulatory Affairs Associate/Specialist
By SciPro At San Diego, CA, United States
Be able to provide support to regulatory management and project teams and implement regulatory strategy while delivering documentation on time.
Maintain and manage databases containing regulatory information, submissions, and correspondence.
BS in life sciences with a minimum of 3 years of experience in Regulatory Affairs
Experience submitting IND filings utilizing eCTD formatted submissions highly desirable.
Independently plan daily work to complete time-sensitive assignments while following general instructions for project completion.
Review documents necessary for the regulatory site documentation related to the shipment of drug products to clinical sites.
Director/Senior Director – Quality Engineering And Regulatory
By PBS Biotech At Camarillo, CA, United States
Accountable for management and maintenance of program for sterilization qualification, shipping/transport studies, packaging, and shelf life.
Accountable for maturation of existing quality systems for risk management and validation.
Program-level experience with validation or equivalent verification/validation, or qualification
Skills/ Abilities Pertinent To This Position
Experience leading and mentoring staff and colleagues
Able to perform analysis to support material selection and qualification of pharmaceutical-grade materials
Senior Manager, Regulatory Affairs Cmc
By Agenus At United States
Participates with senior management to establish strategic plans and objectives.
Interacts with senior management, executives, and/or major customers which frequently involves negotiating matters of significance to the organization.
Directs the activities of a functional area or multiple integrated departments through lower management.
Ensures budgets and schedules meet corporate requirements.
Agenus is Delighted to Provide you With a Comprehensive Benefits Plan, Including Some of the Following:
Makes final decisions on implementation and ensures operational effectiveness.
Senior Manager / Director, Regulatory Affairs
By X4 Life Sciences At Bucks County, PA, United States
Knowledge & Experience of compiling CMC sections of ANDAs & NDAs (eCTD), reviewing DMFs
Title: Senior Manager, Regulatory Affairs OR Director, Regulatory Affairs
$140k-$220k + benefits + bonus
10+ years' RA experience within pharmaceutical manufacturing
Working knowledge of FDA regulations (e.g., 21 CFR 314.50 and 314.94 and 21 CFR 201 and 208) and applicable FDA guidance
Experience working with & overseeing external resources (e.g., CROs, CMOs) and a team of direct reports
Senior Director, Regulatory Affairs
By Relay Therapeutics At Cambridge, MA, United States

You have earned your B.S and/or M.S. and bring 10+ years of relevant work experience in pharmaceutical regulatory affairs.

You have a "can do" attitude, and you are passionate about the impact of regulatory work on patients.

Senior Director Regulatory Affairs
By Experian At Washington, DC, United States
Excellent communication, organization, and time management skills.
Minimum 5-10 years of experience either on Capitol Hill, at state or federal financial regulatory body, or with a policy-oriented organization.
Experience working on financial services, technology, and privacy policy issues preferred.
Excellent interpersonal skills with the ability to work with diverse personality types and across party lines.
Excellent writing and communications skills are essential.
Competitive pay and comprehensive benefits package, with a bonus target of 20%
Senior Manager Regulatory Affairs
By Smith Hanley Associates At Chicago, IL, United States
Senior Manager, Regulatory Affairs (Advertising & Promotion)
Assures timely and accurate review of advertising and promotional material to meet internal timelines and requirements.
5+ years of pharmaceutical experience with 3+ years of pharmaceutical advertising and promotion experience.
Knowledge of the pharmaceutical industry, Regulatory Affairs for prescriptions drugs.
Knowledge of the pharmaceutical product NDA and labeling processes.
Strong interpersonal skills with the ability to influence others.
Director / Senior Director Of Clinical Affairs
By Pendulum Therapeutics At San Francisco, CA, United States
Knowledge and experience of GCP standards
Experience in giving clinical presentations to medical audiences including physicians and allied health care providers
Experience in building positive, collaborative relationships with members of the academic community
Experience in clinical and preclinical protocol design
Interest and experience in educating audiences with varied scientific backgrounds regarding mechanism of action(s) and clinical utility
Work closely with the Chief Medical Officer to provide medical oversight and support of clinical studies, both sponsor-driven and investigator-initiated studies
Associate Director Regulatory Affairs
By GQR Global Markets At United States
Manage submission plans and timelines to ensure approvals are timely and development objectives are met .
Manage regulatory data and information within systems .
Strong scientific background with at least five (5) years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries.
Proven ability to successfully manage major submissions and critical projects to deadlines.
Basic knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects).
Represent and coordinate regulatory information as a team member, covering clinical, non-clinical, CMC, labeling, and post-approval change activities .
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.
Research Director/Regulatory Affairs Mngr
By Napa Research Center At Pompano Beach, FL, United States

Opportunity to advance career in clinical research company. Great financial compensation plan with healthcare benefits. Overlook responsibility of a great dedicated staff and be an integral part in ...

Director- Iso Regulatory Affairs
By Jupiter Power At Austin, TX, United States
5-7 years of experience in regulatory affairs, policy, trade compliance, strategy or business development in the power market industry
Experience in PJM, MISO or NYISO power markets
Experience in managing external consultants and deriving/approving external scopes of work
Experience representing power generation in ISO/RTOs
Extensive work experience beyond the 5-year minimum.
Lead ISO/RTO Regulatory Affairs Activities for FERC jurisdictional electricity markets, including formulation of internal policy goals and external representation
Hiring _ Senior Regulatory Affairs Specialist _ Remote
By Intellectt Inc At Lake Forest, IL, United States
Must have 3-5 years of experiences in Medical Device Regulatory Affairs
Have working knowledge in EU MDR
Have working knowledge in Regulatory Change Assessment in
Have working knowledge in US and EU medical device submissions
Have experience supporting internal and external inspections
Have experience with continuous improvement activities
Director, Regulatory Affairs Cmc
By Agenus At United States
Participates with senior management to establish strategic plans and objectives.
Interacts with senior management, executives, and/or major customers which frequently involves negotiating matters of significance to the organization.
Directs the activities of a functional area or multiple integrated departments through lower management.
Ensures budgets and schedules meet corporate requirements.
Agenus is Delighted to Provide you With a Comprehensive Benefits Plan, Including Some of the Following:
Makes final decisions on implementation and ensures operational effectiveness.
Associate Director, Regulatory Affairs, Supply Chain
By Avanos Medical At California, United States
Provide leadership to maintain compliance with domestic and international regulations as well as management of the Avanos Mexico facilities’ State Licenses.
Continue to increase education/knowledge in the area of Regulatory Affairs.
Making a difference in our products, services and offers, never ceasing to fight for groundbreaking solutions in everything we do;
Eight to ten years experience in Regulatory Affairs.
Exceptional written and verbal communication skills.
Team player with excellent organizational skills.
Sr Director Regulatory Affairs Cmc
By Discover International At United States
Extensive knowledge of global regulatory requirements and guidelines for CMC in drug development.
Provide strategic guidance on CMC requirements for drug development programs.
Strong leadership skills, with a track record of managing high-performing teams.
Excellent communication and interpersonal skills for effective collaboration.
Strong problem-solving and strategic thinking abilities.
Develop and implement global regulatory CMC strategies aligned with corporate objectives.
Senior Regulatory Affairs Associate, Fsp
By Parexel At , Remote
Management Strong management with depth of experience working for global health authorities.
Experience with project lifecycle and management
Strong management with depth of experience working for global health authorities.
Interacts with the assigned Project Assistant (PA) to ensure accurate financial management and for general project support.
Interacts professionally at multiple levels including senior management within a client organization.
Successfully penetrates executive management levels or other business units within a client organization.
Senior Manager Regulatory Affairs
By Athletic Greens At United States
Minimum of 8+ years of demonstrated Regulatory Affairs experience and in-depth knowledge of regulatory requirements in the Dietary Supplement industry.
Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
Bachelor's Degree in Science, Nutrition or related field preferred, or a combination of education and equivalent work experience.
Review and approve new and/or revised labels and ensure labeling content and product documentation is developed in accordance with regulatory requirements.
Review formula, raw material and finished product specifications to ensure compliance with regulatory requirements.
Prepare and process documentation required for product registrations, notifications and certifications in applicable international markets