- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a Senior Director (Sr. Principal Scientist) Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that ... to optimize product labeling and obtain shortest time to approval by global regulatory agencies.You will independently manage projects, functioning as the… more
- Merck & Co. (Rahway, NJ)
- …shortest time to approval by global regulatory agencies.Reports to Associate Vice President, Executive Director, or Senior Director in the General ... Job DescriptionWe are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help advance… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development, Respiratory will focus on driving strategy, development, and ... excellence in the late development of assets within the Respiratory Section of Global Clinical DevelopmentMay serve as a senior therapeutic area content expert… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description Senior Consolidation Accountant: The Global Controller's organization at our Company ensures the financial integrity of the ... Sheet, Income Statement, and Statement of Cash Flows for assigned accounts.- The Senior Consolidation Accountant reports directly to the Associate Director of… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Device Development Associate Principal Scientist - Development Strategy, Design Controls and Risk Management Our company's ... from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance.This position will interact… more
- Merck & Co. (Rahway, NJ)
- …of Biologics and Biopharmaceutics, have 10-15 direct reports composed of experienced, senior and associate scientists.- The successful candidate will effectively ... Job DescriptionOur Company is a global health care leader with a diversified portfolio...manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with decision-makers across multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential ... difference? The Position We are seeking a collaborative and science-driven global regulatory expert who wants to work with innovative investigational medicines.… more
- Merck & Co. (Rahway, NJ)
- …Development - Mixed Modalities, and lead a team comprised of 10-15 experienced senior and associate scientists.- The main responsibilities include leading the ... Job DescriptionOur company is a global health care leader with a diversified portfolio...formulation and process development and document technical reports and regulatory filings. The successful candidate will be key in… more
- Merck & Co. (Rahway, NJ)
- …Biologics and Biopharmaceutics, have 8-10 direct reports composed of experienced, senior and associate biopharmaceutic scientists.- The successful candidate will ... Job DescriptionOur company is a global health care leader with a diversified portfolio...technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- Senior , Clinical Study Associate Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC...team and serves as ad hoc member to the Global Project Team for late stage projects. This position… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …understanding of professional working environment as well as Quality Assurance and global regulatory requirements such that identification of risks is recognized ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...oriented in the execution of processes, as directed by senior staff, playing a supportive role in ensuring adherence… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …equal opportunity employer including veterans and people with disabilities.SummaryThe Associate Director will be responsible for developing and implementing Clinical ... hands on population PK and PKPD analyses and participate in regulatory interactions and submissions representing the Clinical Pharmacology and Pharmacometrics/… more
- Tris Pharma (Monmouth Junction, NJ)
- …have an immediate opening in our Monmouth Junction, NJ facility for an Associate Director, Alliance Management.Tris Pharma has a long track record of successful ... alliances, from global commercial partnerships to R&D collaborations to manufacturing/distribution partnerships....departments across all stages of the product lifecycle. The Associate Director, Alliance Management will be accountable for managing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical/oncology project development preferred- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the safety surveillance sub-function within the US East Coast Development Hub comprised of Senior Global Safety Leads, Global Safety Leads and Senior ... professionals, HAs, ECs, DMCs, and Academia. Line management of Senior Global Safety Lead(s), Global ... Safety Lead(s), Global Safety Lead(s) and Global Safety Scientist(s)/ Associate within Safety Surveillance. Essential… more
- Pfizer (New York, NY)
- …registration, progress reports, supplements, amendments and periodic experience reports. As a Senior Associate , your knowledge and skills will contribute towards ... willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires… more
- JPMorgan Chase (New York, NY)
- …managing emerging risks and promoting responsible business growth. As a Compliance - Executive Regulatory Briefings - Senior Associate in our Regulatory ... LOBs/Functions including Control Management. Candidate will develop expertise on the firm's regulatory agenda as well as a deep understanding of how regulatory… more
- JPMorgan Chase (Brooklyn, NY)
- …offers high visibility and the chance to develop extensive working relationships. As a Regulatory Reporting Senior Associate within the CIB Controllers - ... CIB Controllers. This is a high-impact opportunity to ensure regulatory compliance and reporting for JP Morgan Securities LLC...strength and the diverse talents they bring to our global workforce are directly linked to our success. We… more
