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DIRECTOR OR SENIOR DIRECTOR, REGULATORY AFFAIRS

Responsible for managing and prioritizing workload for regulatory staff. Develops and establish strategic regulatory plans and interfaces with project team members, both within the organization and with a diverse range of clients,...

CompanyVeranex, Inc.
AddressSan Jose, CA
CategorySales/marketing
Salary$165,000 - $263,000 a year
Job typeFull-time
Date Posted 2 days ago See detail

Director or Senior Director, Regulatory Affairs

Veranex, Inc.

San Jose, CA

$165,000 - $263,000 a year

Responsible for managing and prioritizing workload for regulatory staff. Develops and establish strategic regulatory plans and interfaces with project team members, both within the organization and with a diverse range of clients,...

Senior Manager/Associate Director, Regulatory Affairs, Strategic Global Labeling - Combination

Biospace

North Chicago, IL

Develop and direct strategic regulatory planning, creation, and revision of labeling for combination product and device submissions (pre and post approval) with an understanding of Global requirements to lead the Labeling Sub team...

Senior Manager, Regulatory Affairs Vendor Governance

Biospace

California, United States

Own initiatives and day to day responsibilities in support of vendor oversight within RA. Negotiation and problem solving between Gilead RA leads and Vendor resources. Able to gather information or assign tasks or activities for o...

Senior Product Stewardship & Regulatory Affairs Specialist Job

Arkema

United, PA

Prepare and maintain commercial and R&D composition databases, SDSs and labels, packaging requirements, certificates of compliance (Kosher, FDA, RoHS etc.), product registrations and approvals (including FIFRA, NSF, UL, etc.), for...

Senior Manager Regulatory (Boise, ID or Loveland, CO)

Simplot

Boise, ID

Medical, dental, vision coverage. 401(k) savings plan. Paid Family Building Leave. Generous Paid Time Off - Eligible employees may accrue up to 160 hours in year 1. 10 Paid Holidays. Relocation Assistance Program (where applicable...

Senior Manager/Associate Director of Regulatory Affairs

Tempus

Chicago, IL

Developing and leading global regulatory strategies to support business objectives. Leading submissions and correspondence with global regulatory authorities, including 510(k),PMA, De Novo authorizations, IDE, MDR CE marking, UKCA...

Senior Manager, Regulatory Affairs - Proliant Health & Biologicals

Lauridsen Group, Inc.

Ankeny, IA

Professional conduct with high attention to detail. Strong verbal and written communication skills. Ability to work collaboratively and coordinate with team members. Competence in multitasking and organizational methods. Self-star...

Senior Manager Regional Regulatory Affairs

Biospace

King Of Prussia, PA

You will be the primary CSL representative to regional health authorities for assigned products.. Develop the establishment and maintenance of high quality relationships with regional health authorities and collaborating with resp...

Senior Manager, Regulatory Affairs Biocides - Remote

Steris

Alpharetta, GA

Home Based / Remote opportunity. 20% Domestic Travel Required. 10% International Travel Required. Identify and keep current with the various US EPA, EU BPR and other international country submission/registration/approval and compl...

Senior Manager, Regulatory Affairs

Apellis Pharmaceuticals

Remote

$132K - $167K a year

Manage, review and organize documents intended for regulatory submissions. Act as a liaison with project teams to accomplish specific regulatory deliverables (eg agency meeting briefing materials, orphan designation applications,...

SENIOR MANAGER REGULATORY AFFAIRS

Tk-Chain Llc

Princeton, NJ

$80,000 - $170,000 a year

Ensures that appropriate CMC regulatory activities occur in support of both pre and post-approval submissions while meeting aggressive timelines and adhering to the highest quality standards. Must be able to effective articulate c...

Senior Manager, Regulatory Affairs, CMC

Beigene

Remote

$133,400 - $178,400 a year

Lead, develop and implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for the assigned project to ensure on-time and high- quality global submissions for investigational, market, and post-appro...

Solta Senior Manager, Regulatory Affairs

Solta Medical

Bothell, WA

$120,000 - $180,000 a year

Responsible for developing and implementing global regulatory strategy and roadmaps through deep understanding of the competitive market landscape, regulatory / legislative initiatives, and product marketing strategy for product p...

Senior Manager, Regulatory Affairs - Product Development

Arthrex

Naples, FL

$114K - $145K a year

Develop and implement regulatory strategies for Product Development and continuous improvement projects, ensuring alignment with business objectives and regulatory requirements. Lead assigned team(s) in establishing short-term and...

SVP - Internal Audit Senior Manager - Regulatory Capital Reporting - Hybrid

Citi Private Bank

Lorida, FL

Deliver audit reports, Internal Audit and Regulatory issue validation and business monitoring and governance committee reports in the area of Regulatory Capital Reporting. Lead reviews for all types of reviews, including the most...

Senior Manager, Risk & Regulatory Advisory

Morgan Franklin

Texas, United States

Work with emerging growth companies and established enterprises (bothpubliclytraded and privately held) on a wide variety of projects including Sarbanes-Oxley ("SOX") readiness and compliance, internal audit, and ERM.. Assist...

Manager, Global Regulatory Affairs, Marketed Products - Now Hiring

Takeda Pharmaceutical

Bronx, NY

$186,000 per year

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas and. I further attest that...

Counsel Senior Manager - Legal Entity Governance: Public, Regulatory and Corporate Affairs

Wells Fargo

Charlotte, NC

Work on matters for the subsidiaries of Wells Fargo & Company, including support for all aspects of Legal Entity corporate governance, planning and preparing for board and committee meetings, overseeing board evaluations for subsi...

Regulatory Affairs Senior Program Manager

Biospace

San Francisco, CA

6+ years of Regulatory Affairs experience in the biopharmaceutical industry or equivalent Pref Knowledge of regulatory requirements and early to mid-clinical stage experience with US regulatory submissions for therapeutic products...

Manager, Global Regulatory Affairs CMC - Now Hiring

Takeda Pharmaceutical

Brooklyn, NY

$133,200.00 to $223,200.00 per year

I further attest that all information I submit in my employment application is true to the best of my knowledge.Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC in Cambridge, MA with the...

Manager - Regulatory Affairs - Therapeutic Area

Biospace

Plainsboro, NJ

Compile and submit responses to FDA communications. MANAGER, THERAPEUTIC AREA: Compile, submit and maintain applications (IND, NDA, Biologics, Devices) to government agencies in support of research and marketed products. Create an...

Senior Director/Director, Global Regulatory Affairs Early Respiratory & Immunology

Astrazeneca

Boston, MA

Work on cross-project initiatives of high importance for the early R&I portfolio. Lead the development and implementation of innovative global strategies of increasing complexity to improve the likelihood of regulatory success. Ac...

Manager, Global Regulatory Affairs CMC Submissions Management - Now Hiring

Takeda Pharmaceutical

New York, United States

$138,500 - $186,000 per year

I further attest that all information I submit in my employment application is true to the best of my knowledge.Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC Submissions Management in...

Senior Manager/Associate Director, Regulatory Strategy

Biospace

Boston, MA

Throughour in-depth understanding of the biological pathways involved inmineralization, we are pursuing the development of therapeutics to address theunderlying causes of these debilitating diseases. You will develop and implement...

Senior Manager, Public Affairs

Abbott Laboratories

Alameda, CA

$144,100 - $288,300 a year

Career development with an international company where you can grow the career you dream of. Free medical coverage for employees* via the Health Investment Plan (HIP) PPO An excellent retirement savings plan with high employer con...

Senior Specialist Regulatory Affairs - Nutrition - Lake County , IL or Columbus, OH

Abbott Laboratories

Lake Forest, IL

$72,700 - $145,300 a year

Training and career development, with onboarding programs for new employees and tuition assistance Financial security through competitive compensation, incentives, and retirement plans Health care and well-being programs including...

Clinical Affairs Senior Manager Immunossays

Biomérieux

United States

A family-owned company, bioMrieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve publi...

Senior Regulatory Compliance Assurance Program Manager

Intuit

Atlanta, GA

Come join our amazing team of leaders, learners and world-class compliance professionals. Working as a member of Intuits Legal, Compliance & Policy Organization (LCPO, you will be responsible for ensuring Intuit meets important r...

Senior Associate - Regulatory Affairs

Biospace

Princeton, NJ

Contribute to the preparation, review, approval, and dispatch of global submissions to regulatory applications (pre-submission activities, orphan drug applications, IND/INDs/CTAs/NDAs/MAAs etc.). Support the planning and conduct o...

Regulatory Tariffs & Advice Letters Senior Manager

Pge

Oakland, CA

Cultivate partnerships with PG&Es Law and Regulatory Relations Departments, other California utilities, and regulatory bodies such as the CPUC, CEC, FERC, and CAISO to drive policy and proceeding decisions.. Guide the line of bus...