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Senior Director Regulatory Affairs Jobs in San Diego, California

Senior Regulatory Affairs Specialist
By NuVasive, Inc. At , San Diego $96,000 - $160,000 a year
Determine/document appropriate regulatory strategy for proposed new products and initiate necessary activities by working with Regulatory management as needed.
Knowledge of US FDA Quality System Requirements (QSR), and ISO 13485.
This position is remote eligible, but we prefer candidates commutable to our San Diego, CA office
Ability to determine, communicate and make recommendations for submission and approval requirements to others
Confer with other departments about the regulatory requirements of new product designs and/or changes to existing designs
Understanding of regulatory terminology, pre-market submission types, and requirements
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.
Executive Director, Regulatory Affairs Strategy
By Neurocrine Biosciences At San Diego, CA, United States
Provides strategic guidance on global regulatory requirements to management and project teams
Detailed knowledge of FDA/EMA/ICH regulations and guidance for global drug development, preparation and management of IND/CTA/MAA/BLA/NDA applications
Regulatory experience and detailed knowledge outside the US (Japan and/or EU) is preferred
Manages preparation of all regulatory submissions (IND/CTA/MAA/BLA/NDA)
Master's degree preferred and 15+ years of related experience, OR
PhD and 12+ years of related experience OR
Senior Manager Regulatory Affairs
By Jasper Therapeutics At Redwood City, CA, United States
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:
Must be able to effectively identify data needs, and successfully present to management.
Manage/track regulatory submission documents and timelines, collaborating with Clinical Operations and CROs to ensure timely submissions of all deliverables.
Provide expertise in translating local, regional, and international regulatory requirements into workable plans with cross-functional teams.
Maintain up-to-date knowledge of current regulations for applicable territories. •
Other tasks and responsibilities as directed by the Regulatory Affairs leadership team.
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
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
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.
Senior Specialist, Regulatory Affairs
By H&H Group At Orlando, FL, United States
Good communication skills, strong project management ability and teamwork ability.
Familiar with the process of pet food export to China, experience in official certification documents works.
Salary and benefits will be competitive and commensurate with experience.
At least 1 year working experience in pet food
MOA registration program U.S. official documentation section
Label and advertising compliance review
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
Director Regulatory Affairs Jobs
By Altasciences At United States
Critical thinking skills and ability to acquire and apply knowledge quickly;
Lead, manage and prepare clinical trial submissions;
Lead, manage, prepare, and submit meeting requests and meeting information packages to health agencies;
Lead, manage, prepare, and submit controlled correspondence to regulatory agencies;
8+ years of regulatory experience in an industry setting;
Strong knowledge of drug development and regulatory policy;
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 ...

Senior Manager Regulatory Affairs | $90,000- 140,000/Yr
By PWR Staffing & Recruiting At New York, NY, United States
Ensure claims are compliant with The Avon and local regulatory requirements and consistent across labels, advertising, and other consumer communications
Over 8 years of Regulatory Affairs experience within a regulated industry, preferably skin and personal care products, including OTC
Product development experience is strongly preferred
Skin and personal care, including OTC claim review experience, strongly preferred
Track record adhering to compliance requirements (i.e. FDA, Health Canada, EPA, FTC, cGMP, ISO, etc.)
Strong written communication skills, especially detail oriented and technical material
Director Or Sr Director Regulatory Affairs - East Coast Remote Flex
By GQR Global Markets At Massachusetts, United States
Manage third party vendor partner performance and workload to support regulatory operations and regulatory publishing.
Manage regulatory budgets, resources, and timelines to optimize operational efficiency and meet business objectives.
Experience in managing regulatory inspections, audits, and interactions with regulatory agencies including direct contact with regulatory agencies.
Final accountability for regulatory documentation, ensuring adherence to FDA and other health authority specifications and timelines
Preference for East Coast-based candidates.
Senior Regulatory Affairs Manager - Hybrid
By Hi-Quality Recruits At New York, NY, United States
Ensure claims are compliant with the company and local regulatory requirements and consistent across labels, advertising, and other consumer communications
Over 8 years of Regulatory Affairs experience within a regulated industry, preferably skin and personal care products including OTC
Track record adhering to compliance requirements (i.e. FDA, Health Canada, EPA, FTC, cGMP, ISO, etc.)
Strong written communication skills, especially detail oriented and technical material
Experience communicating with cross-functional teams and customers, including verbal presentations
Excellent organizational and analytical skills to complete assignments accurately
Senior Director, Energy Facilities Regulatory Development
By Worley At , Baton Rouge
Project management skills to successfully manage profitability, schedule and quality for multi-million dollar regulatory assignments for complex projects.
Track record of successful management of major regulatory projects / work packages to meet agreed budget and schedule
Overall Responsibilities and Key Accountabilities
25+ years of professional experience, preferably with an environmental consulting organization, an operator, contractor or regulator
Expert knowledge in the environmental and regulatory issues associated with energy development in the US
Excellent client and agency interfacing skills
Client Services Director Regulatory Affairs- Boldapprovals (East Coast)
By BOLDSCIENCE At United States
Experienced financial management including budgets, forecasting, recoverability
Experience managing a variety of medical communications tactics
Manages resourcing needs across the team in conjunction with the VPs
Manages and inputs into the career development of direct reports and their teams, closely reviewing goals and objectives
Line manages multiple team members of varying levels, providing constructive and actionable feedback to team members
Extensive experience working within regulatory affairs and/or the medical communications industry
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/Senior Director Regulatory Affairs
By RBW Consulting At United States
7-10+ years Regulatory Affairs experience
Experience in development and commercial product lifecycle (Phases 1-3, Marketed Products)
Relevant experience with regulatory applications (IND / CTA / NDA / MAA etc.)
Success in filing IND's/CTA's in Oncology
Educated (MSc, PhD, or PharmD) in the Life Science, Pharmacy or similar field.
Direct exposure to FDA/EMA etc. Interactions
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
Senior Director, Cmc Regulatory Affairs
By Albion Rye Associates At United States
Knowledge or experience with regulatory requirements in other regions and familiarity with GMP regulations is a plus.
In-depth knowledge of ICH requirements and regulatory requirements in the US/EU.
Proficiency in authoring complex technical documents, including CTD M2 and M3 sections, and life cycle management.
8+ years of experience in regulatory CMC within the pharmaceutical or biopharmaceutical industry.
Excellent oral and written communication skills are essential.
Detail-oriented, self-motivated, and comfortable handling broad responsibilities in an entrepreneurial, fast-paced environment.
Director Regulatory Strategist Jobs
By Viatris At United States
Extensive knowledge of the regulatory environment and ability to leverage this to impact regulatory strategy development and implementation
Knowledge of assigned therapeutic areas/disease areas is preferred
Regulatory Affairs Professional Certification preferred
Access – Providing high quality trusted medicines regardless of geography or circumstance;
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership – Leveraging our collective expertise to connect people to products and services.
Associate Director/Director Regulatory Cmc
By TG Therapeutics, Inc. At United States
Maintains current knowledge of regulations and guidelines (FDA, ICH, and others as required).
5-10 years experience in regulatory CMC
Coordinate and lead the task of drafting responses to CMC-related questions from FDA or foreign health authorities.
Work with functional groups to provide timely responses to CMC questions from regulatory authorities.
Coordinates activities for meetings with FDA and other regulatory authorities.
Coordinates with cross-functional teams to define contributions to submissions.
Senior Director Of Quality And Regulatory Affairs
By Goodall Brazier At Texas, United States
12+ years related GMP experience in biotechnology, chemistry, biochemistry, microbiology, pharmaceutical, manufacturing, or laboratory environment. 7-10 years experience in Quality Management.
Expert knowledge of GMP, FDA, and EMA regulatory requirements applicable to Biologics including Cell/Gene/Viral therapy products
Regulatory Knowledge CBER, CDER, CDRH, and other global agencies
Experience interacting with FDA and other global agencies
Ability to prepare audit reports, quality agreements, standard operating procedures, and CAPA reports in accordance with companies Quality System requirements
Experience leading a Quality Dept at a CDMO (preferred)
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