- Merck & Co. (Rahway, NJ)
- Job DescriptionAssociate Director , Business System Labeling Management Required experience and skills: Min. 5-10 years of experience with Pharmaceutical ... Regulatory Affairs Operations with Labeling Process and/or Digital Enablement...soon as possible.Job Description: Seeking a full-time Business System Associate for the Labeling Operations area within the GRACS… more
- Merck & Co. (San Francisco, CA)
- …component of decision-making at our Company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas. - This ... development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an... Associate Director will work with scientists within… more
- Eisai, Inc (Exton, PA)
- …as with Facilities, Quality Assurance, Quality Control, Regulatory , and CMC Program Management departments.The Associate Director of Biologics Operations ... your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and...for Biologics Pilot Plant campaigns. Support providing data for regulatory documents as required.7. Ensure adherence of operations to… more
- Merck & Co. (Rahway, NJ)
- …Development Associate Principal Scientist - Development Strategy, Design Controls( Associate Director Equivalent) Our company's Device Development & ... controls and risk management activities.Lead the preparation of materials for program presentations for management review and regulatory submission.Contribute to… more
- Merck & Co. (Rahway, NJ)
- …- Interacts closely with key partner organizations ( as a lead GCS Planning program representative ) such as clinical development, regulatory , quality and other ... development teams and the operational/executional arms within the business.-- - - The Program Clinical Supplies Project Manager ( Program CSPM) serves as the… more
- Insmed Incorporated (San Diego, CA)
- …lead on a PDT as required by the business.ResponsibilitiesThe Analytical Development Operations associate director is responsible for building a team to take ... Team representative as an Analytical Lead for a drug program .Key Responsibilities:Responsibilities include developing and optimizing analytical methods using… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …design pull you in? Are you ready to experiment with us? The Position The Associate Director of Nephrology Key Opinion Leader Marketing will be a pivotal driver ... with brand/therapy area vision and message. Relationships Reports to Senior Director of Cardio Renal Marketing Responsible for providing interface with key… more
- Merck & Co. (North Wales, PA)
- …operational reviews, issue escalation/mitigations, presentations at Sr Management meetings, program level cross functional meetings and governance). Responsible for ... engagements. This includes the ability to:--Strong knowledge of clinical research regulatory requirements (eg, GCP and ICH) Proven ability to manage competing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... Initiates contact w/KOL and prepares material for KOL interactions on a program based need; Involvement with in-licensing and acquisitions on individual due… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Humana (Montgomery, AL)
- …the candidate will be required to work in either Central or Eastern Time. Associate Director , Regulatory Intake Compliance is responsible for enterprise-wide ... operational value and reduces compliance risk exposure for the organization. The Associate Director , Regulatory Intake Compliance will be responsible… more
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. The Associate Director Global Regulatory Affairs, Neuroscience is responsible ... Global Regulatory Teams (GRTs) and representing the regulatory function on cross-functional Global Program Teams....and Takeda R&D. **How you will contribute:** + The Associate Director will be responsible for increasingly… more
- Boehringer Ingelheim (St. Joseph, MO)
- …such as governance review, project team meetings, planning activities and FDA communications. Associate Director Act as Regulatory Affairs (RA) core or ... **Description** Manager The Manager, Regulatory Affairs (RA) Pharma Safety & Efficacy will...as defined. + Supports specific infrastructural projects as assigned. Associate Director + Responsibility for the safety… more
- Rhythm Pharmaceuticals (Boston, MA)
- …adapt, learn, and our tenacity to overcome barriers, together. Opportunity Overview The Associate Director (AD) of Regulatory Operations is responsible for ... coordinating across functions, and ensuring quality, accuracy, and adherence to regulatory guidelines. Additionally, the Associate Director supports… more
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. The Associate Director , Global Regulatory Affairs Advertising and Promotion (GRA ... pertaining to prescription medicine promotion. **How you will contribute:** + As our Associate Director , Global Regulatory Affairs Advertising and Promotion… more
- Abbott (Alameda, CA)
- …work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Associate Director Regulatory Affairs - APAC** will work ... Alameda, CA, location in the Diabetes Division. As a manager, the function of an Associate Director Regulatory Affairs, APAC (Asia Pacific) is to combine… more
- Rhythm Pharmaceuticals (Boston, MA)
- …learn, and our tenacity to overcome barriers, together. Opportunity Overview In the Associate Director , Regulatory Affairs role, you will be responsible ... the development and delivery of science-based, solution-oriented and internally aligned regulatory strategies for the program (s) under your accountability. You… more
- Takeda Pharmaceuticals (Boston, MA)
- … strategies in collaboration with their regional counterparts. **Accountabilities:** + The Associate Director will be responsible for complex or highly complex ... / Purpose:** + Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or… more
- Abbott (San Diego, CA)
- …diversity, working mothers, female executives, and scientists. **The Opportunity** This position, ** Associate Director Regulatory Affairs** , works out of ... role is part of the RA New Product Introduction (NPI) team, reporting to the Director of Global NPI and US Regulatory Affairs. We're empowering smarter medical… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , GRA CMC Small Molecules where you will oversee the ... Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC. **How you...long-term disability coverage, basic life insurance, a tuition reimbursement program , paid volunteer time off, company holidays, and well-being… more
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