Environmental 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

A high attention to detail and strong project management skills

Hybrid work from home after the first 3 months of employment.

Benefits including Medical Insurance and a 401K plan

Assisting with permitting requirements and documentation (air quality, wastewater, Tiered Permitting, storm water, etc.)

A personable demeanor and professional communication skills, both verbal and written

Computer skills, including proficiency in Word and Excel

Experience in management of multiple tasks simultaneously, within established schedules and timelines.

Establish or update operating procedures and communicate them so that employees follow environmental requirements.

Possess working knowledge of environmental standards and rules (i.e., RC14001, RCRA, NPDES, Clean Water & Air Acts)

Experience in various environmental related reporting (SARA 312, 313, Air Emission Inventory, CERCLA, NPDES DMR, MACT compliance submissions).

Experience in preparation of Waste Characteristic evaluations for off-site waste disposal

Highly motivated with strong problem-solving skills and capable of working with minimal supervision.

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