Regulatory Affairs CMC

The contractor will work within a team to execute regulatory strategies and gain approval for global post approval changes. · Knowledge of global CMC guidelines regarding post approval changes. · Execution of detailed, global regulatory strategies for submission and approval of p ...

Responsible for developing and implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations and guidances. · ...

The CMC Regulatory Affairs Specialist will be responsible for developing and implementing regulatory strategies for assigned pharmaceutical products in accordance with global regulations and guidances. · ...

This position will have an emphasis on Chemistry, Manufacturing, and Controls (CMC) regulatory strategies and document preparation but will also have exposure to strategic and tactical regulatory affairs activities supporting the clinical and nonclinical projects within Regulator ...

· Company Description · Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, ...

Antares Therapeutics is seeking an experienced Regulatory Affairs–CMC Strategist (Consultant) to provide senior strategic advisory leadership for global, phase-appropriate CMC regulatory strategies supporting early-stage small molecule product development. · Advanced degree (PhD, ...

The Director, CMC Regulatory Affairs will lead CMC regulatory strategy and execution in support of global clinical development programs.This role serves as the regulatory lead on cross-functional CMC teams and is responsible for authoring, managing, and overseeing high-quality gl ...

Serve as the CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones for assigned products through the product lifecycle. · ...

A Director, Regulatory Affairs CMC is a leadership role within Regulatory Affairs responsible for the global regulatory strategy and execution related to the pharmaceutical quality and manufacturing of drug products. · Develop and execute global CMC regulatory strategies for prod ...

The Director, Regulatory Affairs CMC (RA CMC) will provide Regulatory Affairs CMC leadership for development teams throughout the development program (discovery, development, submission, approval and post-approval) of Viking Therapeutic's candidate projects. The Director RA CMC w ...

The Director, CMC Regulatory Affairs provides strategic leadership and ownership of Chemistry, Manufacturing, and Controls (CMC) regulatory activities across Capricor's product lifecycle. · ...

The Director, CMC Regulatory Affairs provides strategic leadership and ownership of Chemistry, Manufacturing, and Controls (CMC) regulatory activities across Capricor's product lifecycle. This role develops and executes CMC regulatory strategy, ensures compliance with global requ ...

Regulatory Affairs Manager CMC · San Fran - Hybrid/Onsite · We are partnering with a well-established global pharmaceutical and combination product company that has been operating for over 20 years and is currently expanding its pharmaceutical division. As part of this growth, th ...

Corcept is leading the way in cortisol modulators research. · Lead preparation of CMC regulatory documents; · ...

· Description · The Director, Regulatory Affairs CMC (RA CMC) will provide Regulatory Affairs CMC leadership for development teams throughout the development program (discovery, development, submission, approval and post-approval) of Viking Therapeutic's candidate projects. The ...

Job Description: · The Manager, CMC Regulatory Affairs is responsible for executing Chemistry, Manufacturing, and Controls (CMC) regulatory activities across the product lifecycle, with a primary focus on supporting the BLA pathway and advancing other pipeline candidates from de ...

We are seeking an experienced Director, Regulatory CMC to provide strategic and operational leadership for Chemistry, Manufacturing, and Controls regulatory activities across a growing portfolio of development and commercial products. · ...

This role involves developing regulatory strategies for pharmaceutical products in accordance with global regulations. Key responsibilities include leading CMC dossier preparation for life-cycle changes to commercial products and collaborating with clients on regulatory complianc ...

We're seeking a highly motivated and qualified regulatory CMC author/writer for the Global Regulatory Affairs CMC & Device organization in the Plasma-Derived Therapies Business Unit at Takeda. · Manages routine CMC authoring and submission activities for an assigned product or pr ...

Onsite 5 days a week - Candidates must be located in San Diego, CA · The Director, CMC Regulatory Affairs will lead CMC regulatory strategy and execution in support of global clinical development programs. This role serves as the regulatory lead on cross-functional CMC teams and ...