- Lundbeck (Edmond, OK)
- …transform lives. Join us on our journey of growth! As a Psychiatry Account Manager , you lead the promotion of our psychiatry portfolio, executing sales and marketing ... Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies and… more
- Tris Pharma (Monmouth Junction, NJ)
- …Monmouth Junction, New Jersey, Tris has an immediate opening for a SR. Manager or Manager , Quality Management Systems (QMS). Title commensurate with ... supports, oversees and manages the Quality Assurance (QA) Investigations and Product Quality Complaints Team to ensure manufacturing quality controls and procedures… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the management of ... PV Regulatory Intelligence (PVRI) and dissemination across CSPV stakeholders for...negotiation and transfer of PV Business in case of Product Divestment. Collaborate with DSI audit groups to ensure… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications. It's ... processes Ensure that all activities comply with company and or regulatory procedures, practices and guidelines Follow all safety & environmental requirements… more
- Lundbeck (Raleigh, NC)
- …grow with LundbeckOur ideal candidate will have the ability to be a specialty product expert with an understanding of requisite market complexities in order to be ... to stakeholders in the primary care and neurology settings. As an Account Manager , you lead the promotion of our psychiatry portfolio, executing sales and marketing… more
- Eisai, Inc (Nutley, NJ)
- …of brand plansStrong communication and presentation skillsUnderstanding of legal and regulatory issues impacting pharmaceutical product marketing as well as ... that can help simplify the patient journeyIdentify and ensure training ( product , disease state and compliance training) for promotional speakers and related… more
- Kraft Heinz Company (Glenview, IL)
- Job Description EMPLOYER: Kraft Foods Group Brands LLC POSITION: Global Manager , FSQ Regulatory Affairs, Export DUTIES: The Global Manager , FSQ Regulatory ... team and be responsible for enabling and reviewing nutritional and regulatory compliance for Kraft Heinz products globally through various business units, corporate… more
- Grand River Aseptic Manufacturing (Grand Rapids, MI)
- …5 years of prior management / leadership Thorough understanding of cGMP, FDA guidelines and multinational regulatory standards Must have proficient computer ... individuals improving lives every day. Overview of this Position: The senior manager provides direction and leadership to Grand River Aseptic Manufacturing (GRAM)… more
- Amylyx Pharmaceuticals (Cambridge, MA)
- …apply. THE OPPORTUNITY The Quality team is expanding and looking to hire a Manager of QC/AD, reporting to the Director of QC/AD. This individual will be responsible ... of the development, qualification, and validation of methods to support product characterization, release and stability across multiple programs. Technical review… more
- Abbott (Temecula, CA)
- …colleagues serve people in more than 160 countries. JOB DESCRIPTION: Senior Manager Quality Assurance Reliability Working at Abbott Our medical devices help more ... the complaint investigation process during audits, inspections and assessments by regulatory agencies, globally. Works closely with manufacturing sites to identify… more
- BioSpace (Tampa, FL)
- …with Lundbeck. Our ideal candidate will have the ability to be a specialty product expert with an understanding of requisite market complexities in order to be ... to stakeholders in the primary care and neurology settings. As an Account Manager , you lead the promotion of our psychiatry portfolio, executing sales and marketing… more
- Octapharma Plasma (Independence, MO)
- …(1) year experience in a Quality Assurance role required. Demonstrated knowledge of FDA , EMA, ISO, and other regulatory standards applicable to plasma collection ... help, we encourage you to join us! Center Quality Manager I This is What You'll Do: Operate independent...and local regulations, as well as industry standards (eg, FDA , EMA). Reports critical incidents and negative trends to… more
- Sazerac Company (Carrollton, TX)
- …needs. Support TTB audits and general inquiries by assisting the Regulatory Manager and providing organized, accessible government documentation. Maintain ... Bio The Government Compliance Administrator is responsible for ensuring full regulatory compliance and operational accuracy related to spirits processing, inventory… more
- Medtronic (Fridley, MN)
- …within the US or onsite at another US-based Medtronic facility. As the Senior Program Manager of the Regulatory Workstream, you will be a key member of the ... Regulatory Strategy Meeting and develop close working relationships with the Regulatory leadership team. + Integrate the Product -DNA plans with those being… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …the Regulatory Affairs, Advertising and Promotion Director. The Senior Manager Regulatory Affairs, Advertising and Promotion will oversee therapeutic area(s) ... The Senior Manager position within the Regulatory Affairs...Form 2253 + Monitor the external environment to advise product teams on evolving regulatory requirements related… more
- Boehringer Ingelheim (St. Joseph, MO)
- **Description** Manager The Manager , Regulatory Affairs (RA) Pharma Safety & Efficacy will represent the US regulatory safety and efficacy function in ... project team meets US requirements in development activities. The manager will be responsible for FDA meetings...accordance with the project governance model to drive Target Product Profile objectives. + Provides consistent regulatory … more
- Ascendis Pharma (Princeton, NJ)
- …to working together as one team to achieve extraordinary results. The Senior Manager Regulatory Affairs, Advertising and Promotion will be an internal expert ... promotion of prescription drug and biologic products. The Senior Manager Regulatory Affairs, Advertising and Promotion is...product (s) and will ensure materials are submitted to FDA via 2253. + Support metrics to measure and… more
- Abbott (Alameda, CA)
- …their glucose levels with our new sensing technology. **The Opportunity** This ** Regulatory Affairs Manager - International Compliance Operations** will work ... their glucose levels with our new sensing technology. This ** Regulatory Affairs Manager - International Compliance Operations**...+ Assist in SOP development and review + Provide regulatory input to product lifecycle planning +… more
- Abbott (Sylmar, CA)
- …Our location in **SYLMAR, CA** currently has an onsite opportunity for a Manager of Regulatory Affairs in the Cardiac Rhythm Management Business. This ... regulatory strategies, submissions to support clinical trial activities and product launches. This individual applies advanced regulatory expertise to guide… more
- AbbVie (North Chicago, IL)
- …compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP). The ... YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager , RA Global Regulatory Strategy US and Canada is responsible… more
