- Boehringer Ingelheim (St. Joseph, MO)
- …as governance review, project team meetings, planning activities and FDA communications. Associate Director Act as Regulatory Affairs (RA) core or ... to drive Target Product Profile objectives. + Provides consistent regulatory advice to project teams regarding the...as defined. + Supports specific infrastructural projects as assigned. Associate Director + Responsibility for the safety… 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 ... for developing innovative global regulatory strategies and providing strategic regulatory guidance...and Takeda R&D. **How you will contribute:** + The Associate Director will be responsible for increasingly… more
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director Global Regulatory Lead, GRAD Oncology. You will ... in collaboration with their regional counterparts. + As the Associate Director , you will be responsible for...are effectively implemented and maintained in line with changing regulatory and business needs. + Ensures project … more
- Takeda Pharmaceuticals (Boston, MA)
- …for the following job opportunity: **JOB LOCATION:** Cambridge, MA **POSITION** : Associate Director , Regulatory Data Governance Lead **POSITION ... DESCRIPTION** : Takeda Development Center Americas, Inc. is seeking an Associate Director , Regulatory Data Governance Lead with the following duties: Oversee… more
- Takeda Pharmaceuticals (Boston, MA)
- … strategies in collaboration with their regional counterparts. **Accountabilities:** + The Associate Director will be responsible for complex or highly complex ... needs and anticipates such changes to lead adaptations to regulatory strategy. + Ensures project team colleagues,...(s) of responsibility or oversees direct reports responsible. The Director will lead all submission types. + Accountable for… 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 ... cycle of Rhythm products. This role reports into the Director , Global Regulatory Affairs. Responsibilities and Duties...Affairs. Responsibilities and Duties + Act as the Global Regulatory Lead on multi-disciplinary project teams and… 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 ... medicine promotion. **How you will contribute:** + As our Associate Director , Global Regulatory Affairs...and commercial materials. + You will be product or project business lead for global CMRP at Takeda +… more
- Abbott (Alameda, CA)
- …work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Associate Director Regulatory Affairs - APAC** will work ... Diabetes Division. As a manager, the function of an Associate Director Regulatory Affairs, APAC...annual licenses, registrations, listings and patent information. + Create project plans and timelines. + Lead cross functional groups… more
- AbbVie (Mettawa, IL)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director , Regulatory Affairs US Advertising and ... cross-functional, multidisciplinary, therapeutic teams, and executes multidivisional initiatives. The Associate Director envisions the future by using global… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …self. Become a **maker of possible** with us. **Summary of Job Responsibilities** The Associate Director of Regulatory Affairs will provide regulatory ... is not limited to the development and implementation of regulatory strategies for new product submissions, project ...of regulatory strategies for new product submissions, project management for regulatory affairs submissions, handling… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- **Job Description Summary** As Regulatory Affairs Associate Director , you will be responsible for leading RA team members involved in device project ... primary FDA contact in the US. You will oversee regulatory activities for the new product portfolio, primarily focusing...and position RA team as solution providers. + Own regulatory strategy to ensure all Pharmaceutical Systems (PS) products… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- Regeneron Cell Medicine is looking for an Associate Director in Regulatory CMC for biologics who will be responsible for the development and submission of ... SME members that may include, Development Manufacturing Supply and Quality (DMSQ), Regulatory Project Management & Program management, and external cross… more
- Merck (Austin, TX)
- … updates. + Audit vendors/partners of SaMD/IVD/Companion Diagnostics **Reports to** - Director Regulatory Compliance, Device Quality and Regulatory ... **Job Description** This position will be part of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). The primary… more
- J&J Family of Companies (Spring House, PA)
- …at https://www.jnj.com/innovative-medicine We are searching for the best talent for an ** Associate Director , Regulatory Medical Writing** within our ... This role will support one or more of our therapeutic areas within the X-TA Regulatory Medical Writing area. This position is open globally and may be in Europe (eg,… more
- BeOne Medicines (San Mateo, CA)
- …when recalls or product complaints arise during product lifecycle for the assigned project . + Provide CMC regulatory review for clinical protocols and ... **_General Description:_** BeOne is seeking an experienced and energetic regulatory professional to manage, evaluate, and complete regulatory projects consistent… more
- Gilead Sciences, Inc. (Foster City, CA)
- …or other programs. You will lead Regulatory Submissions Teams or other Regulatory Project Teams and represent Global TA Regulatory on cross-functional ... together. **Job Description** You will act as the Regional Regulatory Lead on more complex or multiple products, compounds,...direct reports. + Provides matrix management and leadership to project teams. + Provides accurate and thorough input and… more
- Merck (Rahway, NJ)
- …Management Office (PMO); and Administrative Professionals. **Position Description/Summary:** The GPAM Associate Director , Value & Implementation Project ... and realize its full potential. The Associate Director is expected to provide project management...Project Management System, Project Management Training, Project Planning, Publications Management, Regulatory Compliance, Risk… more
- United Therapeutics (Madison, WI)
- …like lungs, pancreases and hearts. **Who you are** We are looking for a regulatory strategist who will advise on regulatory pathways, managing documentation and ... timelines, and supporting the preparation and execution of regulatory submissions for our whole organ tissue engineering program....a related area of study + 8+ years of project or people management experience + Must have written… more
- Gilead Sciences, Inc. (Foster City, CA)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** Regulatory Affairs Labeling is a core function within Gilead's Global ... Regulatory Affairs organization and acts as a critical strategic...oversees other team members representing RA Labeling on RA Project Teams, at cross-functional submission team meetings, and on… more
- BeOne Medicines (Emeryville, CA)
- **_General Description:_** Sr. Manager/ Associate Director , Supply Chain CMO Management & PM will own and enable the communication, coordinate tasks between the ... supply + Partner with internal stakeholders such as CMC, Regulatory , Quality to ensure on time commercial launch &...amendments, and renewals, aligning with the business strategies + Project management of multiple complex project teams… more