Archive for the ‘careers’ Category

Job Title: Director, Regulatory Affairs

Position reports to: Vice President, Regulatory Affairs & Product Quality/Safety

Location: Emeryville, CA

Purpose of Position:
This Director, Regulatory Affairs is responsible for providing strategic and operational leadership in the area of advertising and promotion, labeling, and management of the Contact Center. This position will serve as the company’s senior regulatory liaison to the FDA’s OPDP, and works closely with representatives from medical, legal and commercial to support the interests of the business, and comply with applicable FDA regulations. Represents Regulatory Affairs on the promotional review committee, and provides guidance to members regarding the current regulatory environment and regulatory considerations that may impact business activities.

Leads the development of product labeling, and manages the submission of labeling changes to health authorities.

This position will also provide leadership and management of the Contact Center for product information by HCPs and patients. This activity includes the management of any vendors/CRO and consultants required to support this function.

Primary Responsibilities and Duties:
• Work through cross-function team to provide regulatory guidance on product promotional items. Work closely with Medical, Legal and Commercial members to develop materials consistent with business needs and FDA compliance. Manages the submission of materials to OPDP, and serves as regulatory liaison to OPDP.
• Leads and manages product labeling generation, and post-approval labeling changes.
• Provides leadership and organizational management of the Contact Center, including the generation and renewal of SRLs/FAQs, providing input on ad hoc questions, generation and summary of monthly activities via dashboard summaries.

Minimum Education Typically Required:
BS/MS or equivalent in a relevant scientific discipline.

Amount of Experience Typically Required:
Requires a minimum of 5 years experience (10+ years desired) with drug products in Regulatory Affairs, preferably in pharmaceuticals, biologics, or bio-pharmaceuticals.

Skills Required
Possesses a thorough knowledge of current FDA regulations and guidances regarding advertising and promotional activities, labeling requirements, and medical information support.

Possesses leadership skills and ability to interact with senior management

Excellent written and verbal communication abilities

Negotiation skills are essential

Expert knowledge of the pharmaceutical business, and proficiency at representing and interpreting the strategic business objectives of the company effectively is critical.

Travel:
Willing to travel up to 20%

Associate Director, Non-Clinical Development

POSITION SUMMARY
The Associate Director of Non-Clinical Development will be responsible for developing and implementing non-clinical strategy for new drug product development at Zogenix. This person will also oversee and manage non-clinical studies at contract research organizations, as well as be responsible for writing non-clinical sections of regulatory submissions.

MAJOR AREAS OF RESPONSIBILITY
• In collaboration with Zogenix’ Senior Development staff, lead development of non-clinical strategy and execute a plan to enable rapid drug product approval for Relday™ (risperidone-SABER-DosePro) and future drug products
• Participate on drug product development teams by providing direction, oversight and management for all Zogenix non-clinical studies, and oversight for partner-conducted non-clinical studies, including Zohydro™, Relday™ and all future drug products.
• Work with Regulatory Affairs to write non-clinical sections of all regulatory submissions.

MINIMUM JOB QUALIFICATIONS
• Self-motivated individual with the ability to think and work independently
• Minimum of 9 years industrial experience in drug-device combination product development including experience managing a team and managing CRO’s
• Experience in CNS and Pain non-clinical product development required, some experience in parenteral or controlled release non-clinical product development preferred
• PhD in Toxicology, Pharmacology or a related discipline, or equivalent combination of education (MS or DVM) and drug product development experience. DABT certification a plus
• Demonstrated success and experience working in a complex drug development environment
• Excellent communication skills with ability to clearly express themselves both verbally and in writing
• Strong understanding of ICH, FDA and EMEA guidelines pertaining to preclinical / nonclinical safety

PREFERRED JOB QUALIFICATIONS
• Demonstrated success working effectively outside defined scope of responsibility, when required.
• Have a bias for action and display a sense of urgency.
• Possess strong skills in leadership, communication, project management and budget management while maintaining high quality and efficiency standards.

SPECIAL WORKING CONDITIONS
• Up to 5-10% travel required

REPORTING RELATIONSHIP
Reports to Sr. Director, Product Development

OFFICE SITE
Emeryville, CA