CMC Regulatory Senior Manager

Job DescriptionJob DescriptionR&D Partners is seeking to hire a CMC Senior Manager in New Brunswick, NJ. Your main responsibilities as a CMC Senior Manager:· Participate in the development of the CMC regulatory strategy for post-approval small molecule product submissions, including global supplements/variations and responses to health authority queries.·...

R&D Partners is seeking to hire a CMC Senior Manager in New Brunswick, NJ. Your main responsibilities as a CMC Senior Manager: Participate in the development of the CMC regulatory strategy for post-approval small molecule product submissions, including global supplements/variations and responses to health authority queries. Prepare and review CMC...

PREREQUISITES BS/BA degree in Scientific Discipline (master's or higher preferred) with 5+ years in the pharmaceutical industry, preferably with 3+ years CMC regulatory experience Skills/Knowledge Required: Experience with CMC regulatory documents (global registrations, including NDAs, MAAs and others, responses and supplements/variations) Knowledge of...

PREREQUISITES BS/BA degree in Scientific Discipline (master's or higher preferred) with 5+ years in the pharmaceutical industry, preferably with 3+ years CMC regulatory experience Skills/Knowledge Required: Experience with CMC regulatory documents (global registrations, including NDAs, MAAs and others, responses and supplements/variations) Knowledge of...

Pay Range: $(phone number removed)-$(phone number removed) Company Overview: The people of Memorial Sloan Kettering Cancer Center (MSK) are united by a singular mission: ending cancer for life. Our specialized care teams provide personalized, compassionate, expert care to patients of all ages. Informed by basic research done at our Sloan Kettering...

Job DescriptionJob DescriptionSalary: $130-170kJOB SUMMARY: Responsible for drafting cover letters for submissions and for being the regulatory point of contact internally for DSURs and IBs and for other documents as needed. Supports the implementation of regulatory strategies for product development and commercialization in emerging disease areas.This role...

Associate Director, Regulatory Affairs This position will serve as the company US Agent and a contact point between the FDA and company sites. Responsible to communicate with FDA for all regulatory issues/questions and provide regulatory guidance to internal constituents. It will lead a team of Regulatory Associates and Senior Regulatory Associates...

Job DescriptionJob DescriptionScismic is supporting the growth of a late-stage, publicly traded biopharmaceutical company developing targeted radiotherapies to deliver cancer-killing radiation with cellular level precision to treat patients with high unmet medical needs.  Their vision is to build a specialty, hospital-focused radiotherapeutics company that...

Job DescriptionJob DescriptionScismic is supporting the growth of a late-stage, publicly traded biopharmaceutical company developing targeted radiotherapies to deliver cancer-killing radiation with cellular level precision to treat patients with high unmet medical needs.  Their vision is to build a specialty, hospital-focused radiotherapeutics company that...

Job DescriptionJob DescriptionScismic is supporting the growth of a late-stage, publicly traded biopharmaceutical company developing targeted radiotherapies to deliver cancer-killing radiation with cellular level precision to treat patients with high unmet medical needs.  Their vision is to build a specialty, hospital-focused radiotherapeutics company that...

Job DescriptionJob DescriptionScismic is supporting the growth of a late-stage, publicly traded biopharmaceutical company developing targeted radiotherapies to deliver cancer-killing radiation with cellular level precision to treat patients with high unmet medical needs.  Their vision is to build a specialty, hospital-focused radiotherapeutics company that...

Lead the regulatory efforts for IND-enabling activities, including the preparation of the Investigational New Drug (IND) application for our groundbreaking oncology and CNS therapies targeted for submission this year and early next.Be the go for all things regulatory and acting as a key voice to the future of all trials, SOPs and strategy for these early...

Lead the regulatory efforts for IND-enabling activities, including the preparation of the Investigational New Drug (IND) application for our groundbreaking oncology and CNS therapies targeted for submission this year and early next.Be the go for all things regulatory and acting as a key voice to the future of all trials, SOPs and strategy for these early...

Lead the regulatory efforts for IND-enabling activities, including the preparation of the Investigational New Drug (IND) application for our groundbreaking oncology and CNS therapies targeted for submission this year and early next.Be the go for all things regulatory and acting as a key voice to the future of all trials, SOPs and strategy for these early...

The Regulatory Affairs Manager will create, evaluate and execute domestic and/or international regulatory tasks related to the following: global submissions, technical file compilation, facility registrations, special projects and strategy to drive market growth worldwide. Additionally, this individual will provide leadership and guidance to the Regulatory...

The Regulatory Affairs Manager will create, evaluate and execute domestic and/or international regulatory tasks related to the following: global submissions, technical file compilation, facility registrations, special projects and strategy to drive market growth worldwide. Additionally, this individual will provide leadership and guidance to the Regulatory...

The Regulatory Affairs Manager will create, evaluate and execute domestic and/or international regulatory tasks related to the following: global submissions, technical file compilation, facility registrations, special projects and strategy to drive market growth worldwide. Additionally, this individual will provide leadership and guidance to the Regulatory...

The Regulatory Affairs Manager will create, evaluate and execute domestic and/or international regulatory tasks related to the following: global submissions, technical file compilation, facility registrations, special projects and strategy to drive market growth worldwide. Additionally, this individual will provide leadership and guidance to the Regulatory...

The Regulatory Affairs Manager will create, evaluate and execute domestic and/or international regulatory tasks related to the following: global submissions, technical file compilation, facility registrations, special projects and strategy to drive market growth worldwide. Additionally, this individual will provide leadership and guidance to the Regulatory...

Description Are you looking for an opportunity to grow your leadership and analytical chemistry experience to further support the lives of animals? Are you looking to coach a team of scientists to develop further innovation in animal health? Are you passionate about building a team structure and foundation to meet present and future needs? If these questions...