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Associate Regulatory Program Director Jobs

Associate Director Of Regulatory Services
By Synterex At United States
Strong interpersonal and leadership skills to influence without authority, motivate others, and manage conflicts
The position will be responsible for the management and oversight of the following areas:
Grow the regulatory intelligence capabilities within the organization
BS degree in a scientific field, with 8 years of experience in a biotechnology or pharmaceutical setting; Advanced degree preferred.
Excellent written and verbal communication skills
Excellent word processing, SharePoint, Excel, E-mail and online meeting tool skills
Associate Director, Program Quality
By Generation Citizen At New York, United States
3+ years experience in instructional coaching, adult learning and data management/analysis.
Experience with learning management systems, Google Suite, Salesforce and other CRMs.
Maintains current knowledge of coaching and learning trends and research, reporting findings and making recommendations to the National Program team.
Prior experience coaching adults, staff and building and growing professional relationships with a diverse group of internal and external stakeholders.
Experience leading professional development trainings or workshops for adults with an equity centered lens.
Experience building relationships with educators and school or district administrators.
Associate Director, California Water Program
By The Nature Conservancy At , $108,200 - $159,500 a year
Experience with financial management of a large program.
BA/BS degree and 10 years’ experience in conservation practice or equivalent combination of education and experience.
Experience designing, implementing, and directing complex or multiple projects of strategic importance while meeting deadlines.
Supervisory experience, including motivating, leading, setting objectives and managing performance.
Experience using public and private fundraising tactics to fund projects.
Experience in developing partnerships with non-profit partners, community groups, water users, and/or government agencies.
Associate, Regulatory Jobs
By Revlon At Edison, NJ, United States
Regulatory experience in the cosmetic industry, with a particular focus of EU fragrance allergens is a plus.
IT Skills (Microsoft Office, SAP, etc.)
Analytical skills and understanding technical scientific information
Strong written and oral communication skills are required. Strong interpersonal skills are important for working in fast-paced and matrix driven environment
Gathering, generating, and managing technical fragrance information
Provide Regulatory guidance, and support, including but not limited to:
Pediatric Associate Program Director
By CMU Health At Saginaw, MI, United States
Three years of teaching experience (required)
Opportunity to teach, treat and lead positive change throughout the region
Time allocations for research and publishing
Clinic located in a heath care hub, featuring ambulatory and hospital settings
Medium-sized city within a friendly community
Low cost of living, ample housing, easy commute to large cities and international airport
Global Program Associate Director
By Novartis At East Hanover, NJ, United States
Strong project / program management skills
Expert planning and tracking skills, ability to use proper tools in program management
Well organized, focused on results, capable of managing multiple projects, excellent time management skills with respect to priorities and self-management
Contributes to Global Program Management deliverables associated with the program
Along with Finance, assembles and monitors financial forecasts and communicates variances/deviations to the GPT
Masters or Doctorate in life sciences (or MBA with bachelor’s degree, or equivalent experience in life science)
Associate Director, High Potential Program
By Saint Mary's College of California At Moraga, CA, United States
Strong written, verbal, and non-verbal communication skills.
Demonstrated experience working with diverse populations across race, class, gender, sexuality, age, and/or ability.
Demonstrated experience working with underrepresented students in secondary or postsecondary setting.
Build trusting relationships with a diverse student population by delivering personalized, constructive, engaging, motivating, and informative coaching sessions.
Monitor and track TRIO student performance and progress through college systems (Conexed, GaelXpress/Retention Alert).
Maintain consistent and confidential records of individual student data, interactions, interventions and referrals.
Regulatory Associate Jobs
By Charter Research At The Villages, FL, United States
7. Report protocol deviations and serious adverse events to the IRB according to protocol and IRB requirements.
2. Exceptional planning/organizational skills and attention to detail.
3. Strong verbal and written communication skills.
1. 1 year of clinical research experience preferred.
1. Prepare regulatory documents for new study submissions to the IRB and sponsor.
Track the status of new submissions and inform clinical operations of relevant updates for study activation planning.
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.
Regulatory Associate Jobs
By Pharmaron At Baltimore, MD, United States
2+ years of experience in a clinical research environment.
Perform initial and subsequent IRB submissions.
Create and maintain the Investigator Site File for all studies awarded to Pharmaron CPC.
Generate all essential documents (i.e., Form FDA 1572, Financial Disclosure Forms, etc.) for submission to sponsor.
Report deviations/violations and Serious Adverse Events to the IRB.
Ensure IND safety reports are submitted to the PI and IRB for review.
Regulatory Associate Jobs
By Voltus At United States
Excellent project management skills. Must be incredibly efficient while also exercising judgment in allocating limited resources.
1-2 years experience in the energy sector preferred, with some working knowledge of the wholesale markets.
Master our business by working across the organization (Operations, Energy Markets, Engineering) and use that knowledge in advocacy.
Excellent written and verbal communication skills, effectively distilling complex ideas. Comfortable with basic data analysis.
Graduate degree (e.g., J.D. or Masters Degree) strongly preferred, or equivalent experience, with 0-2 years of post-degree work experience.
Work with cross-functional teams, especially Energy Markets, to develop these communications.
Esg & Regulatory Program Manager
By Cisco At San Jose, CA, United States
Program Management Skills and Responsibilities
Program management of integration of ESG and Regulatory initiatives into SCO functional responsibilities for execution.
Excellent time management and planning skills can shift priorities in a dynamic environment.
You are knowledgeable and experienced with both Agile and Waterfall methodologies, and certification in these practices is a plus.
Establish strong relationships, influences, and maintains engagement with functions outside of SCO, including ONEx (Operations) Portfolio and Program Management team.
Handle risk management/mitigation while driving closure to major program issues.
Associate Director, Regulatory Cmc
By BioSpace At San Diego, CA, United States
Strong sense of planning and prioritization, and the ability to work with all levels of management.
Ensure that CMC content is complete, well-written, and meets all relevant requirements.
Manage regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP/quality investigations throughout development.
Biologics experience required; cell or gene therapy experience strongly preferred. Medical device experience also preferred.
Excellent interpersonal skills to communicate difficult concepts and persuade others.
Strategic thinking and strong problem-solving skills with outstanding attention to detail.
Associate Director Global Regulatory Cmc - Cell Therapy
By Shepherd Regulatory Search At Greater Philadelphia, United States
Leads interactions with FDA and other Health Authorities for CMC-related topics (including management of regulatory deliverables and commitments).
Provides CMC Regulatory leadership, serving as an expert for global regulatory CMC requirements and emerging trends for cell therapy products.
Plans, execute, and manages regulatory CMC submissions, including BLA/MAA, INDs, CTAs/IMPDs, briefing documents, and responses to queries.
Minimum of 10 years of pharmaceutical/biotech experience, including five years of Global Regulatory Affairs (CMC) experience.
Experience as a RA CMC product lead.
Experience in Cell or Gene Therapy.
Associate Director Global Regulatory Cmc - Cell Therapy
By Shepherd Regulatory Search At Greater Boston, United States
Leads interactions with FDA and other Health Authorities for CMC-related topics (including management of regulatory deliverables and commitments).
Provides CMC Regulatory leadership, serving as an expert for global regulatory CMC requirements and emerging trends for cell therapy products.
Plans, execute, and manages regulatory CMC submissions, including BLA/MAA, INDs, CTAs/IMPDs, briefing documents, and responses to queries.
Minimum of 10 years of pharmaceutical/biotech experience, including five years of Global Regulatory Affairs (CMC) experience.
Experience as a RA CMC product lead.
Experience in Cell or Gene Therapy.
Associate Director Unaccompanied Children's Program
By Administration for Children and Families (ACF) At Washington, United States

Summary This position is located in the Department of Health and Human Services, Administration for Children and Families, Office of Refugee Resettlement, Unaccompanied Children Programs, located in ...

Associate Program Director Jobs
By Material At New York, United States
Possess deep knowledge of risk management and mitigation
Manage and adjust for any changes in project scope, schedule and / or budget
Monitor and manage multiple project workflows
Excellent strategic, analytical and problem solving skills
Manage and/or mentor junior team members
Possess excellent written and verbal communication skills, high attention to detail
Regulatory Program Specialist (Remote)
By OCHIN, Inc. At United States
Maintains a body of knowledge regarding all health care and health IT laws and regulations, including but not limited to:
Skilled Nursing Facilities Payment System
Reviews, revises, and/or drafts policies and procedures to meet regulatory requirements
Two years’ experience working in a healthcare regulatory affairs department.
Certification in Healthcare Compliance (CHC) preferred, or ability to obtain certification within two years.
Applicable healthcare industry experience such as experience with hospitals, FQHC’s, and governmental healthcare regulations are desired.
Associate Program Director Jobs
By Vanderbilt University At , Nashville, 37232, Tn
Manages the hiring, supervising, and developing of administrative personnel including workflow management and annual performance evaluations.
Identify potential grant opportunities, draft materials for applications, and coordinate with A&S Grants Management team to submit grant applications.
Work with RPW Director and A&S Grants Management team to draft and submit financial reports to funding agencies.
Serves as the Line Manager for Program Coordinator, postdocs, and interns/observers.
A Bachelor’s degree from an accredited institution of higher education is required .
At least six years of professional experience is preferred .