- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.SummaryThe Associate Director , Regulatory Operations - Dossier Planning is ... of the US Dossier Planning team. The Associate Director provides leadership and oversight to...INDs, original and supplemental NDAs/BLAs/MAAs. The Associate Director partners with the Head of Regulatory … more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. Summary The Associate Director is responsible for developing RWE strategies for assigned product(s) and ... Eisai Salary Transparency Language:The base salary range for the Associate Director , Global RWE (Real World Evidence),...the employment eligibility of all new hires in the United States . Please click on the following… more
- Eisai, Inc (Nutley, NJ)
- …employers to electronically verify the employment eligibility of all new hires in the United States . Please click on the following link for more information: ... plans).Collaborate with cross-functional teams (eg, brand, HEOR, market research, sales, regulatory , legal, field market access teams) to develop aligned market… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. ResponsibilitiesEnsure global regulatory plans support a precision medicine approach eg integrated ... drug/diagnostic regulatory and submission plans), including HA engagement plans and...to 10% Occasional travel to Health Authority meetings in US and Europe, potentially Japan Daiichi Sankyo, Inc. is… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …robust development plans. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory ... the company's growth, thereby accomplishing corporate goals.ResponsibilitiesDevelop and implement US regulatory strategy for assigned project(s).Strategize and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …US or EU. Preparation of updated Core Data Sheets, and EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI, ... Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience… more
- Merck & Co. (Rahway, NJ)
- …include, but are not limited to:Reports to Executive Director or Associate Vice President, General MedicineDevelops worldwide product regulatory strategy to ... the world.Looking for someone with a growth mindset.Position Description: The Senior Director , Global Regulatory Lead, is responsible for development and… more
- Merck & Co. (Rahway, NJ)
- …of decision-making at our company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This Associate ... on a continuous basis in decision making and driving pipeline impact. The Associate Director will perform job duties independently with minimal supervision… more
- Merck & Co. (Rahway, NJ)
- …Quantitative Pharmacology and Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Associate Director QP2-IO team is part of the Global Clinical ... of drug development and effective communication skills. As a subject matter expert, the Associate Director within the QP2-IO Group will work closely with teams… more
- Merck & Co. (Rahway, NJ)
- …to bring analytical representation and expertise to project teams and support regulatory filings (eg, INDs/IMPDs and BLAs).-The Director selects, trains, and ... Job DescriptionThe Director of Biologics Potency in Analytical Research &...responsible for a team of approximately 10-15 senior and associate level scientists in Rahway, New Jersey. -The position… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. **Summary** The Associate Director , Regulatory Operations - Dossier Planning is ... of the US Dossier Planning team. The Associate Director provides leadership and oversight to...INDs, original and supplemental NDAs/BLAs/MAAs. The Associate Director partners with the Head of Regulatory … more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Associate Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly ... focus on Clinical Regulatory filings and provide regulatory leadership on...you if:** + If you bring good understanding of US FDA and international pharmaceutical guidance, regulations, drug development… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …meet its goals and objectives. This group also represents Gilead's commercial activities to US regulatory agencies. You will manage the commercial regulatory ... Join Gilead and help create possible, together. **Job Description** Regulatory Advertising and Promotion (RA Ad/Promo) is a core...conditions of the applicable plans. **For jobs in the United States :** As an equal opportunity employer,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. **Responsibilities** + Ensure global regulatory plans support a precision medicine approach eg integrated drug/diagnostic ... regulatory and submission plans), including HA engagement plans and...to 10% Occasional travel to Health Authority meetings in US and Europe, potentially Japan Daiichi Sankyo, Inc. is… more
- Cline Davis & Mann (New York, NY)
- …someone in this role may earn as an employee of an HCG Agency in the United States . Salaries will vary based on various factors, including but not limited to, ... category or class of person protected by law. We are seeking a seasoned Associate Scientific Director with a proven track record of leading scientific content… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …robust development plans. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory ... growth, thereby accomplishing corporate goals. **Responsibilities** + Develop and implement US regulatory strategy for assigned project(s). + Strategize and… more
- Bristol Myers Squibb (Madison, NJ)
- …more: careers.bms.com/working-with- us . **Position Responsibilities** + Develop global and/or US regulatory strategy for Oncology products in development and ... Labeling + Anticipate and interpret key trends and changes in the global/ US regulatory environment and provide strategic guidance regarding development plans as… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …US or EU. Preparation of updated Core Data Sheets, and EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI, ... industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + Experience with ex- US … more
- Scotiabank (New York, NY)
- Associate Director , US Structuring &...family, financial, physical, mental, and social health needs. Location(s): United States : New York : New York ... to results, in an inclusive and high-performing culture. **Title: Associate Director , US Non-Investment Grade...Bring** + In-depth non-investment grade expertise; + Understanding of US regulatory considerations and issues + 4-7… more
- Merck (Rahway, NJ)
- …Looking for someone with a growth mindset. **Position Description:** The Senior Director , Global Regulatory Lead, is responsible for development and ... **Job Description** Our Regulatory Affairs team bring new medical advancements to...but are not limited to:** + Reports to Executive Director or Associate Vice President, General Medicine… more
