eNewsletter Signup
Miles
Km80.5

Regulatory Affairs Director

Hyperion Therapeutics

E-Mail to a Friend Add to Job Folder View All Jobs Back to Search Results Share
Location: South San Francisco, CA Posted Date: 5/3/2013 Position Type: Full time Job Code: 13006 Required Education: High school or equivalent Areas of Expertise Desired: Regulatory Affairs

Description


Hyperion Therapeutics, Inc. is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat disorders in the areas of orphan diseases and hepatology.
We are an Equal Opportunities Employer.


We are looking for a Director of Regulatory Affairs to join our growing team.

This position will work to implement the regulatory strategy to move our products to approval as quickly as possible while remaining in compliance with applicable regulations and guidelines while managing the preparation of document packages for regulatory submissions for Hyperion products and by providing regulatory expertise to other departments as needed.

Key Job Responsibilities
•   Responsible for coordinating all aspects of regulatory submissions relevant to the marketed product and post-approval regulatory strategies.  This included maintenance of the existing U.S. IND and NDA, and driving the company’s planned market authorization application in Europe.
•   Strategize with Hyperion clinical team and FDA Study Endpoints and Labeling Division (SEALD) on the development of a Hepatic Encephalopathy (HE) Grading Instrument to be utilized in a Phase 3 program.
•   Lead strategy and communications with FDA CDRH regarding development and approval of a diagnostic assay
•   Strategize and manage post-approval changes pertaining to Chemistry Manufacturing and Controls information and supplemental NDAs associated with label expansions.
•   Manage regulatory submissions (Clinical Trial Applications) associated with global clinical development (non-US).
•   Coordinate regulatory workflow, leading regulatory submission teams, tracking submission timelines, and reviewing technical documents (CMC, clinical and non-clinical information). This included critical review of submissions, reports, protocol, clinical investigational documentation, labeling, and investigational drug shipment documents for changes requiring government approval.
•   Provide clear and valid regulatory guidance and direction to other departments and project teams. Represent regulatory strategy at project team meetings and provide regulatory support for projects which may include clinical, preclinical, CMC and marketing issues.
•   Monitors and improves tracking/control systems.
•   Keeps abreast of US and international regulatory guidance/procedures and changes and performs Regulatory Intelligence searches for projects as needed.
•   Develops and maintains current SOPs in support of regulatory and related functions as needed
•   Assist with the training of less senior regulatory affairs personnel and provide work direction on projects of large scale

Requirements


Job Qualifications:


Supervisory Responsibilities
•   This position supervises Regulatory Affairs Associates and provides additional direction to the Regulatory Assistant when needed
Requirements
•   A strong and demonstrated understanding of FDA regulations, guidance and procedures.
•   Applied experience with regulatory submission compilation.
•   Experience working with Gastroenterology Division at FDA
•   Minimum 8-10 years of pharmaceutical experience, with at least 5+ years of direct Regulatory Affairs experience.
•   Strong leadership skills and excellent verbal communication skills.
•   Strong written communications skills and attention to details.
•   Ability to use Microsoft Word, Excel, PowerPoint.  Microsoft Project a plus.
Education, Certificates, Licenses, Registrations
•   Bachelor degree in a scientific field is minimum requirement.  An advanced degree is a plus and preferred.


If you are interested in this position please submit your resume to jobs@hyperiontx.com, quoting job reference 13006-BSP in the subject line of your resume.

Principals only please.
E-Mail to a Friend Add to Job Folder



By applying to/saving a job using , you are agreeing to comply with and be subject to the Terms of Use for use of our website. To use our website, you must agree with the Terms of Use and both meet and comply with their provisions.

ADVERTISEMENTS