Director, Regulatory Affairs CMC - Paramus

Overview · An established pharmaceutical organization is seeking a Director of Regulatory Affairs CMC Strategy to lead global regulatory planning and execution related to Chemistry, Manufacturing, and Controls (CMC). This role supports products from early development through post ...

· Overview · A Director, Regulatory Affairs CMC (Chemistry, Manufacturing, and Controls) Strategy 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. ...

Overview: · A Director, Regulatory Affairs CMC (Chemistry, Manufacturing, and Controls) Strategy 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. · ...

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. · ...

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. · ...

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 ...

Boehringer Ingelheim is currently seeking a talented and innovative co-op to join our CMC Regulatory Affairs department located at our Ridgefield facility. In this role you will perform regulatory submissions to US NDAs and BLAs and improve compliance tracking of marketed product ...

· Boehringer Ingelheim is currently seeking a talented and innovative co-op to join our CMC Regulatory Affairs department located at our Ridgefield facility. In this role you will perform regulatory submissions to US NDAs and BLAs and improve compliance tracking of marketed prod ...

We are seeking a Technical Project Manager III (CMC Regulatory Affairs) to join our team in Short Hills, NJ. · This role will be responsible for developing and implementing CMC regulatory strategies for assigned pharmaceutical products. · ...

We are hiring CMC Regulatory Affairs (CMC-3) for one of our clients. Responsible for developing and implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations and guidance. · ...

This position will coordinate activities with all functional departments in support of regulatory filings. Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses. · ...

As an Associate Director you will lead the development and execution of global CMC regulatory strategies for our Obesity portfolio. You will guide regulatory activities across development stages, mentor CMC Regulatory Affairs (RA) staff, supporting cross-functional and external p ...

As an Associate Director you will lead the development and execution of global CMC regulatory strategies for the hematology and oncology portfolios. You will guide regulatory activities across development stages, mentor CMC Regulatory Affairs (RA) staff, supporting cross-function ...

As Associate Director you will lead the development and execution of global CMC regulatory strategies for the hematology and oncology portfolios. You will guide regulatory activities across development stages, mentor CMC Regulatory Affairs (RA) staff supporting cross-functional a ...

As an Associate Director you will lead the development and execution of global CMC regulatory strategies for our Obesity portfolio. · ...

The mission of HUTCHMED International Regulatory Affairs is to develop innovative global registration strategies that advance our pipeline through approval in US, EU, and other countries. · Lead CMC regulatory strategy development and implementation that incorporates risk identif ...

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, ...

The Associate Director is responsible for regulatory CMC activities from early development to post-approval phase. · Organize and manage the preparation of submissions to Health Authorities. · Coodinate activites required for timely and accurate reporting of information to existi ...

Job Title: · Associate Director, Regulatory Affairs CMC and Digital Transformation · Job Requisition ID: · 700 · Posting Start Date: · 2/26/26 · At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of ...