- Author or review technical reports as required by CMC function leaders.
- Author, compile, and manage CMC sections of a wide variety of regulatory submissions including, but not limited to, INDa, IMPD, QOS, Briefing book and BLA etc..
- Effectively manage the integrated drafting and reviewing process following aggressive filing timeline.
- Collaborate effectively with CMC SMEs to prepare CMC sections of the regulatory dossiers including IND, INDa, briefing documents, regulatory responses and BLA.
- Effectively manage the regulatory agencies' feedback and ensure timely responses or implementations.
- Critically review and maintain the source documents for consistency, completeness, and quality.
- Minimum Bachelor's degree (M.S. or Ph.D. preferred) in chemical, and/or, Biological Sciences/relevant discipline or equivalent years of experience.
- 5+ years' experience in CMC regulatory filing experience is required.
- Must have strong working knowledge of full spectrum of CMC including cell bank, drug substance, drug product, analytical, formulation and GMP manufacture in general.
- Strong technical writing skill is required.
- Prior experience in the preparation of CMC sections of regulatory dossiers in eCTD format is required, prior BLA filing experience is strongly preferred..
- Prior working experience with regulatory document formatting and eCTD viewer is strongly preferred.
- Knowledge of FDA, EMA and global regulations including ICH guidelines with a strong knowledge of eCTD elements and structure.
- Demonstrated ability to translate technical information from mixed sources into written information suitable for regulatory authorities.
- Working in a cross functional team environment.
- Excellent verbal/written communication skills.
- Proven planning and organizational skills and regulatory writing skills.
- Ability to work in a fast-paced environment with demonstrated ability to simultaneously manage. multiple competing tasks and demands.
- Detail/accuracy oriented.
- Competitive health insurance coverage
- Generous PTO allowance
- 401k match
- Employee Stock Purchase Plan (ESPP)
- Commuter Benefits
- Women's forum / mentoring
- Office based in the heart of San Francisco, near plenty of shops and restaurants
- Fun opportunities to engage with co-workers in-person and remotely
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CMC Regulatory Technical Writer, Associate Director/Director - California, United States - 89bio
Description
THE COMPANY
89bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases. The company's lead product candidate, pegozafermin (BIO89-100), is a specifically engineered glycoPEGylated analog of FGF21. Pegozafermin is being developed for the treatment of nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG).
THE ROLE
Reporting to the our CMC Executive Director, the CMC Regulatory Technical Writer, Associate Director/Director will be responsible for CMC technical document review and writing, authoring and compiling the CMC sections for global regulatory filings by working closely with the cross-functional teams including CMC, Quality, Clinical and Regulatory Affairs to ensure all CMC technical writing objectives are met.
SPECIAL ADVISORY
The FTC has an advisory out on the domain if you are contacted by any group using a similar, but not our exact domain , please Report any Scams
THE RESPONSIBILITIES
THE QUALIFICATIONS
SALARY & LEVEL
89bio considers a range of factors when determining the salary and level. These considerations mean actual salary and level may vary. The salary range for this position is $185,000 - $225,000 and will be commensurate with experience.
THE PERKS
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or based on disability. Proof of Covid vaccination is a condition of employment.
Notice to Recruiters:To protect the interest of all parties, 89bio does not accept unsolicited resumes and we ask that employees, hiring managers and executives not be contacted directly. All recruitment is managed through the 89bio Talent Acquisition Team.
