Ehs Regulatory Specialist Jobs in California

Crisis Management: Assist in handling product-related crises or recalls, coordinating efforts to address safety concerns and regulatory issues promptly.

Bachelor's degree in a relevant field, such as Regulatory Affairs, Product Management, or a related discipline.

Product Documentation: Manage and organize product documentation, including specifications, testing reports, and certificates, to support compliance efforts.

Labeling and Packaging: Review and approve product labeling, packaging materials, and marketing materials to ensure they adhere to regulatory requirements.

Knowledge of relevant regulations and standards in the industry, with a strong focus on product safety and compliance.

Strong attention to detail and organizational skills.

Proficient in Microsoft Word, EndNote, Adobe Acrobat, Acrobat Plug-ins, Document Management Systems, Excel, StartingPoint templates

Manage the regulatory activities log tracking annual and current submissions

Direct publishing experience a plus

Knowledge of the regulatory archival, records and submissions systems with demonstrated ability to learn new systems and processes.

Experience in preparing INDs, CTAs, NDAs, BLAs and MAAs

Excellent writing skills (e.g., English usage), a keen attention to detail, and strong verbal and interpersonal communication skills

Strong organizational and time management skills

Inform management of EHS deviations

Assist in implementing and managing ISO 14001 and 45001 programs and Management Reviews with direct supervisor or assignee

Respond promptly interaction with Plant Management and HR to address EHS related employee issues

Participate/Lead Employee EHS Committee(s) and site management team

Manage multiple projects with varying requirements and deadlines

Incredible company culture and proven management team

MS WORD knowledge with WORD styles to format various documents for regulatory submissions

ECTD publishing experience with using eCTD software to produce a compliant electronic submission

3+ years of Regulatory Proofreading/Publishing experience within biopharma, medical device, IVD, or CRO industries (protocols, amendments, IBs, CSRs, INDs, NDA modules)

QC experience is a plus

REMOTE | Regulatory Publishing/QC opportunity with a well-funded Rare Disease biotech

Experience working with EHS Management software and common reporting tools (e.g. Tableau).

Support and maintain the EHS Management System and drive continuous improvement solutions to incorporate best practices and global alignment

Applies professional knowledge and expertise to provide meaningful insight on the status and health of programs

Participate in EHS continuous improvement activities and manage actions to completion

5+ years of experience in safety programs, operations or an engineering function within a Fortune 500 multinational company.

Build strong relationships with business partners and cross-functional teams to ensure the integration of EHS policies and procedures

Experience working with EHS Management software and common reporting tools (e.g. Tableau).

Support and maintain the EHS Management System and drive continuous improvement solutions to incorporate best practices and global alignment

Applies professional knowledge and expertise to provide meaningful insight on the status and health of programs

Participate in EHS continuous improvement activities and manage actions to completion

5+ years of experience in safety programs, operations or an engineering function within a Fortune 500 multinational company.

Build strong relationships with business partners and cross-functional teams to ensure the integration of EHS policies and procedures