- Ascendis Pharma (Palo Alto, CA)
- The Regulatory Affairs (RA) Associate Director , Labeling will be responsible for labeling activities across programs and stages of development, with ... and supporting global needs as required. The RA Associate Director , Labeling will be overall responsible for...will be overall responsible for ensuring compliance with US regulatory requirements for labeling , and for coordinating… more
- AbbVie (Lake Bluff, IL)
- …Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director , Regulatory Affairs , Strategic Global Labeling - Combination Products ... documentation for healthcare providers and end user. Under the Director of Strategic Labeling , they establish combination...trends and best practices in combination product and device regulatory affairs , review and comment on changing… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …More Years pharmaceutical industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + ... immune disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team...the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …consistency with product labeling and with all applicable regulations. TheSenior Director , Commercial Regulatory Affairs will stay abreast of changes ... on real-world evidence, and creating hope for all facing illness. The Senior Director , Commercial Regulatory Affairs , is responsible for the development… more
- Boehringer Ingelheim (St. Joseph, MO)
- …programs reflect Boehringer Ingelheim's high regard for our employees. As the Manager/Associate Director , Regulatory Affairs Pharma Safety & Efficacy you ... will: Act as Regulatory Affairs (RA) team member in projects...technical input for Freedom of Information Summary and product labeling for assigned projects. + Work in project teams… more
- Amgen (Washington, DC)
- …over 10 million patients worldwide. It's time for a career you can be proud of. ** Regulatory Affairs Senior Director - Global Regulatory Leader - ... this. Let's change the world. Amgen is seeking a Regulatory Affairs Senior Director supporting...development, global registration, achievement and maintenance of desired regional labeling , and effective regulatory agency interactions +… more
- Bristol Myers Squibb (Madison, NJ)
- …personal lives. Read more: careers.bms.com/working-with-us . **Summary:** The role of Associate Director of US Commercial Regulatory Affairs requires the ... Labeling Branch advisory submissions and sub part e/h submissions. + Ensure full regulatory compliance of all promotions with approved labeling and /or FDA… more
- Abbott (Abbott Park, IL)
- … data is maintained in electronic systems. + Depending on specific role, the Associate Director Regulatory Affairs may be involved in various regulatory ... colleagues serve people in more than 160 countries. **Associate Director of Regulatory Affairs ** **About...etc). + Principles and requirements of promotion, advertising and labeling . + Communication skills and ability to: + Communicate… more
- Sanofi Group (Cambridge, MA)
- About the Role The Associate Director , US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in the ... prescription drugs and biologics. Essential Functions + Represents Global Regulatory Affairs (US RA AdPromo) as a...AdPromo input to the development of optimal FDA product labeling on original and supplemental New Drug Applications and/or… more
- BD (Becton, Dickinson and Company) (Covington, GA)
- **Job Description Summary** As Associate Director , Regulatory Affairs , you will be responsible for managing a team that develops and executes the strategy ... project updates, risks and regulation or guidance changes to Corporate Quality and Regulatory Affairs . International Regulatory Affairs and Senior… more
- Novo Nordisk (Princeton, NJ)
- …for a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide strategic ... Establish strong and positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion. Essential… more
- Sanofi Group (Bridgewater, NJ)
- …and Capabilities** + This individual is expected to competently and confidently represent Regulatory Affairs as a key member of cross-functional RC teams for ... The Associate Director RA serves as the regulatory ...leadership role on the review committee (RC) by providing regulatory guidance on promotional labeling and advertising… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across ... regulatory guidance on new concepts, campaigns, and product labeling for the assigned brands. You may manage complex...Experience working with external contractors supporting the work of regulatory affairs is a plus. + Experience… more
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …+ As appropriate, manage the performance review, hiring and firing process for Regulatory Affairs professionals under his/her direction. + Lead by providing the ... of regulatory submissions. + Serves as a regulatory expert for labeling and promotional materials...direction, manage activities, and participate in development plans with Regulatory Affairs Staff. + Effectively deploys appropriate… more
- Boehringer Ingelheim (Ridgefield, CT)
- …to five (3-5) years of experience in the pharmaceutical industry with experience in Regulatory Affairs . + Specific experience in regulatory advertising and ... labeling . Participate in Human Pharmaceutical Review Committee, providing regulatory opinion on promotional communications. Review scientific exchange communications… more
- Takeda Pharmaceuticals (Columbus, OH)
- …applicable regulatory requirements. You will serve as the regulatory expert for labeling on the Global Regulatory Affairs subteam to ensure that ... therapies to patients worldwide. Join Takeda as an Associate Director , Global Labeling Lead where you will...independent skills in the area of regulatory affairs such as understanding broad concepts within labeling… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …for the clinical research aspects of registration activities with a working knowledge of regulatory affairs , in the development of the project strategy and the ... Job Title Senior Director , Clinical Development & Medical Affairs ...Affairs , Strategic Operations, Evidence Generation & Data Sciences, Regulatory Affairs , Pharmacovigilance) Strategy/Portfolio Management, Global Device… more
- J&J Family of Companies (Horsham, PA)
- …experience. + Relevant experience in the pharmaceutical industry (eg, Regulatory Affairs , Clinical, Medical Information, Pharmacovigilance) including at ... Associate Director , Global Labeling Product Leader -...least 6 years of direct regulatory labeling content experience...least 6 years of direct regulatory labeling content experience developing and writing labeling … more
- Boehringer Ingelheim (Ridgefield, CT)
- …development role in the overall BI market approach and informs medical affairs efforts where applicable. The Director , Clinical Development Strategy Team ... Development, Proof of Clinical Principle, Release of Full Development, input into regulatory strategies and labeling discussions). + Provides medical guidance… more
- Philips (San Diego, CA)
- …body audits. Implements internal or external quality system audits. + Reporting to the Director of Regulatory Affairs , the Senior RA Specialist will ... Recommends strategies for earliest possible approvals of clinical trials applications. + Regulatory Affairs representative for the CT/AMI Systems and assists… more