Looking for a unique approach to Regulatory Affairs? Want to push boundaries and bring life-saving medicine to the marketplace? This is the role for you!. My client is a multinational CDMO looking for a Regulatory Affairs Manager to work with the FDA and their client sites to manufacture generic API...
Our client, an exciting and growing Biotech Company, is seeking a Regulatory Affairs professional at the Senior Director level. Launch the company's regulatory strategy having leadership over all regulatory activities. This role will lead the North America regulatory strategy and work extremely clos...
Represent Regulatory Affairs by attending project team meetings, providing regulatory strategies, reviewing project documentation, and participating in design control activities, as scheduled. Excellent employment opportunity for a Regulatory Affairs Consultant in the Somerville, NJ area. Regulatory...
The Senior Associate, Regulatory Affairs is responsible for supporting applications under pre and post approval conditions. Under the direction of Regulatory Affairs management, participate in drug development from early stage development through final formulation, ensuring compliance with principle...
Senior Director - Regulatory Affairs. Provide responses to regulatory agencies regarding clinical research or regulatory application issues. Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards. This role is resp...
Develop an efficient and high value-added Japan regulatory development strategy in line with global strategies Responsible as a contact parson with regulatory authorities (MHLW and PMDA, etc. Develop an efficient and high value-added Japan regulatory development strategy in line with global strategi...
With minimal direction from the Therapeutic Area Head, will conduct the independent review of advertising, promotional, communications and other materials, and help develop and implement regulatory strategies for promotion and advertising campaigns, including serving as regulatory lead for product l...
Updates the Regulatory Affairs advertising and promotion staff, review committees and appropriate other Company staff regarding changes in the current regulatory environment at FDA’s Office of Prescription Drug promotion (OPDP), Advertising and Promotional Labeling Branch (APLB), and other regulator...
The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process and leadi...
The Regulatory Affairs Project Manager is responsible for ensuring that the company aligns with all of the regulations and laws pertaining to our business; Working with federal, state, and local regulatory agencies on specific issues affecting our business; and advises the company on the regulatory ...
Role: CMC2 - Regulatory Affairs - Animal Health. Proven and relevant regulatory affairs experience in pharmaceutical, vaccine, or biological products; or related fields. Knowledge on relevant regulatory guidelines VICH guideline, USP, EU, ICH guidelines and relevant applications. Lead development an...
The Team Lead for Authoring Support Group will be part of the Global Regulatory Operations group and will develop and manage the authoring support group within Regulatory Affairs (RA) to ensure timely and high-quality document delivery to the Regulatory Publishing Group. Experience with document man...
Manager, Regulatory Affairs Compliance and Planning professional will lead or support regional and global projects by effectively delivering assigned projects within GRA on time and within budget. Manager, Regulatory Affairs Compliance and Planning professional is responsible for driving implem...
Manager, Regulatory Affairs integrates and applies knowledge of US regulatory guidelines and federal regulations governing pharmaceutical drug development to all aspects of Our Client’s ’s drug development programs, policies and procedures; ensuring a compliant state of regulatory commitment. Advanc...
Prepare new/revised label packaging for regulatory submissions to the USDA and maintain regulatory documents to ensure site compliance. Support regulatory filing submissions with the USDA for both domestic and international product packaging. ...
Job Title: USA-Regulatory Affairs Specialist Project Lead I (Scientific). This role will be accountable for leading the development and execution of innovative and value-added global regulatory strategies and be responsible for formulating the Global Regulatory Project Strategy (GRPS) for immunology...
This role is the key in ensuring the accurate and the timely submission of all Guerbet regulatory documents, staying current on all US federal regulations to ensure compliance, develop training programs and/or communications documents to meet regulatory requirements, and ensure that regulatory proce...
This position is responsible for the preparation of regulatory submissions required to market medical devices in both the and Europe, support of international product registrations and related regulatory affairs activities, including execution of procedures and systems designed to ensure that the pr...
Updates the Regulatory Affairs advertising and promotion staff, review committees and appropriate other Company staff regarding changes in the current regulatory environment at FDAs Office of Prescription Drug promotion (OPDP), Advertising and Promotional Labeling Branch (APLB), and other regulatory...
Train and obtain access on company tools and systems that support contracting, PO, and invoicing for regulatory affairs in the US and EMEA. In this role you’ll be working with cross-functional teams to assist with the coordination and completion of international regulatory documents. This role will ...
Updates the Regulatory Affairs advertising and promotion staff, review committees and appropriate other Company staff regarding changes in the current regulatory environment at FDA’s Office of Prescription Drug promotion (OPDP), Advertising and Promotional Labeling Branch (APLB), and other regulator...
This role will be accountable for leading the development and execution of innovative and value-added global regulatory strategies and be responsible for formulating the Global Regulatory Project Strategy (GRPS) for immunology products in Early Development. At least - years of relevant pharmaceutica...
The Manager, Regulatory Affairs - Regulatory Project Management (RPM) provides planning and coordination supports for global and US regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL) and global regulatory team (GRT) for as...
This role will be accountable for leading the development and execution of innovative and value-added global regulatory strategies and be responsible for formulating the Global Regulatory Project Strategy (GRPS) for immunology products in Early Development. At least 8-10 years of relevant pharmaceut...
The Regulatory Affairs (RA) Associate Director, Labeling will be responsible for labeling activities across programs and stages of development, with specific responsibility for the United States and the Americas and supporting global needs as required. The RA Associate Director, Labeling will be ove...