The Senior Associate Regulatory Affairs (CMC) provides varying levels of product support to the regulatory Chemistry, Manufacturing and Controls (CMC) department, across regions and phases of development. Sr Associate Regulatory Affairs – CMC - Biotech/R&D/Science. Sr Associate Regulatory Affair...
Keeps abreast of regulatory compliance issues and assists in developing new Regulatory Department procedures, as needed. Prepare, assemble, review and/or evaluate, publish and archive new ANDA and life cycle management regulatory submissions in accordance with local regulatory requirements and guide...
Someone who has good knowledge of Regulatory Affairs/Compliance. ...
Associate) Director, Regulatory Affairs – Permanent – San Francisco Bay Area. Proclinical is seeking an (Associate) Director, Regulatory Affairs for a clinical-stage biopharmaceutical company located in the San Francisco Bay Area. A degree in a life science, chemistry, or chemical engineering or clo...
Corporate/Regulatory Associate. Our corporate/commercial health practice offers general counsel, health regulatory and governance advice to healthcare organizations, associations and professionals. We provide strategic advice and regulatory opinions on a wide variety of issues. ...
The Senior Associate Regulatory Affairs (CMC) provides varying levels of product support to the regulatory Chemistry, Manufacturing and Controls (CMC) department, across regions and phases of development. Support may include organizing, managing and executing on regulatory CMC projects in support of...
We are supporting a small growing biotech in the Bay Area looking for a Senior Regulatory Affairs Associate!. Atleast 2 years experience in a regulatory setting at a biotech company. Strong foundation in biological or physical sciences, with the ability to apply scientific knowledge to regulatory ma...
The Senior Associate will be tasked with the organization, management, and execution of regulatory CMC projects, ensuring the successful support of regulatory submissions. Job Title: Senior Associate Regulatory Affairs – CMC. We are seeking a dedicated and experienced Senior Associate for their Regu...
Job Title: Regulatory Affairs Senior Associate. Join our dynamic, global team as a Senior Associate in Regulatory Affairs. You'll be working closely with our Regulatory Information Management and Systems (RIMS) team, contributing to our mission of delivering regulatory systems and processes that ens...
Job Title: Senior Associate, Regulatory Affairs. Join our Regulatory Affairs team as a Senior Associate and contribute to our ongoing projects. Support the implementation of Veeva Vault, IDMP, EU CTR, and other regulatory initiatives. Provide Subject Matter Expertise in Veeva Vault Configuration and...
Incident Compliance Specialist. To support the services outlined above, R&D’s Incident Compliance Specialist will assist the department Supervisor with oversight of the Special Incident Report (SIR) Unit by providing ongoing training and development for personnel to ensure that department produc...
This manager position within CMC will facilitate product development and global registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Assist Regional Regulatory Represen...
The Sr Regulatory Affairs Specialist is responsible for ensuring digital medical device regulatory clearance to enable market access by demonstrating compliance to applicable regulations through a registration dossier. Provides regulatory guidance and defines regulatory strategy for digital products...
To be considered for the Trade Compliance Specialist opening, here’s what you’ll need to bring with you:. As a Trade Compliance Specialist, you will:. Bachelor's Degree preferred, however 2+ years of undergraduate education PLUS 2+ years' Trade Compliance experience will be considered. Interact with...
Director/Senior Director, Regulatory Affairs. They are looking for a Director or Senior Director of Clinical Regulatory Affairs to join their team. Develop and execute Clinical Regulatory Affairs strategies to support clinical development objectives. You will provide guidance to other members of the...
Compliance & Ethics Specialist. Perform field and desk monitoring to ensure compliance with to relevant laws and regulations. Track, analyze, and report on compliance monitoring progress, identifying trends and potential risks. Provide compliance guidance and support for various initiatives and proj...
Applies basic knowledge of compliance, business, analytical, and communication skills to support compliance programs and processes that promote compliant and ethical behavior, meet regulatory obligations, and prevent, detect, and mitigate compliance risks. This position will focus on compliance with...
Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to project teams, and provides input related to FDA and international product registrations and licensing requirements. Certification is a plus (such as RAC from the ...
This manager position within CMC will facilitate product development and global registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Assist Regional Regulatory Represen...
Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving moderately complex conflicts between those requirements and development issues; also keeps...
As a member of PointClickCare’s Legal and Compliance team, In the role of Compliance Analyst, you will be instrumental in driving key initiatives and projects that have a substantial impact on PointClickCare, its customers, and other stakeholders. Assist in the development of, and ongoing updates to...
Regulatory Affairs Manager - Permanent - San Francisco Bay Area. Proclinical is seeking a Manager, Regulatory Affairs for a global medical device company. The Manager, Regulatory Affairs will:. Leads regulatory resources to ensure timely product registrations, regulatory planning for new product int...
Regulatory Affairs Specialist II. Regulatory Affairs Specialist II:. Regulatory Affairs Specialist II:. Works in close collaboration with internal customers and supports multiple projects to align on regulatory strategy to achieve business objectives. ...
The Privacy Compliance Analyst reports into the Enterprise Risk Management department to ensure continued compliance with state and federal privacy laws affecting Harbor Freight Tools. The Privacy Compliance Analyst will facilitate operational processes, automation, and produce periodic reports rela...
CSG are currently partnered with a prominent full scale glazing contractor in California and actively seeking an experienced Senior Project Manager to join their dynamic team. Responsibilities of the Project Manager:. Establish Schedules of Values for projects, assisting with monthly requisitions, c...