Vice President Regulatory Affairs - San Diego, CA | Biospace
Get Our FREE Industry eNewsletter

Vice President Regulatory Affairs

Regulus Therapeutics, Inc.

Location:
San Diego, CA
Posted Date:
11/16/2016
Position Type:
Full time
Job Code:
528
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Regulatory Affairs, Vice President,

Job Description


Regulus Therapeutics Inc. (Nasdaq:RGLS) is a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs.  Regulus has leveraged its oligonucleotide drug discovery and development expertise to develop a well-balanced microRNA therapeutics pipeline complemented by a maturing microMarkersSM biomarkers platform and a rich intellectual property estate to retain its leadership in the microRNA field.  Regulus is developing RG-101, a GalNAc-conjugated anti-miR targeting microRNA-122 for the treatment of chronic hepatitis C virus infection, and RG-012, an anti-miR targeting microRNA-21 for the treatment of Alport syndrome, a life-threatening kidney disease driven by genetic mutations with no approved therapy.  In addition, RG-125, a GalNAc-conjugated anti-miR targeting microRNA-103/107 for the treatment of NASH in patients with type 2 diabetes/pre-diabetes, has entered Phase I clinical development through its strategic alliance with AstraZeneca.  Regulus is also advancing several programs toward clinical development in renal, hepatic and central nervous systems diseases, both independently and with our strategic alliance partners, Sanofi and AstraZeneca. Regulus' commitment to innovation has resulted in multiple peer-reviewed publications in notable scientific journals and has resulted in the formation of strategic alliances with AstraZeneca and Sanofi.

Regulus is located in San Diego, California and is led by a seasoned executive team experienced in corporate management, business, science, drug discovery and development. Regulus' scientific advisory board consists of world-class scientists and some of the foremost authorities in the field of microRNA research.  

We are currently seeking a highly motivated and hands on Vice President Regulatory Affairs to be part of a unique and exciting opportunity in drug discovery.

Vice President Regulatory Affairs
Reference Code – 528

Regulus is looking for a highly strategic and motivated Vice President Regulatory Affairs responsible for developing and overseeing the company’s regulatory strategy to support its ongoing R&D programs. Responsibilities include directing the company’s interactions with FDA and other regulatory agencies, and managing the preparation of document packages for regulatory submissions from all areas of the company including timely preparation of well-organized and technically accurate FDA and EMA submissions for investigational products.

RESPONSIBILITIES INCLUDE:
•   Manage the preparation and quality check of all regulatory submissions, including INDs, CTAs, and NDAs, to regulatory agencies.  
•   Lead the company’s communications with FDA, EMEA, and other global health authorities including emails, face-to-face meetings, and teleconferences.
•   Provide strategic advice and counsel regarding regulatory requirements.
•   Prepare and/or manage the preparation of documents required for maintenance of INDs and NDAs, such as adverse event reports, pre- and post-approval amendments, annual reports, and drug advertising.
•   Review and edit source documents and summary documents prepared by others for completeness and regulatory compliance.
•   Streamline and maintain regulatory filing and tracking systems for submissions, correspondence, and guidelines.
•   Manage the Regulatory Affairs repository and Regulatory Affairs archives.
•   Participate on project teams and review committees as needed.
•   Maintain close working relationship with Research and Pharmaceutical Development teams.

Requirements


•   Minimum of a Bachelor’s degree in a scientific discipline, or equivalent business experience.
•   Minimum of 15 years of direct, industry related regulatory experience in the pharmaceutical industry.
•   Solid clinical/CMC regulatory experience in drugs.  
•   Previous project management experience within regulatory affairs.
•   Previous experience providing strategic regulatory guidance from clinical candidate selection through PoC is a must.
•   Experience in global Phase I-III clinical studies is a plus.
•   Experience with electronic filing submissions (eCTD)
•   Extensive experience with direct FDA interactions (and with other global regulatory agencies)
•   Excellent working knowledge of current FDA and EMA regulations and ability to apply knowledge strategically and operationally to advance R&D programs.  
•   Outstanding verbal communication, written communication, and presentation skills.  
•   Excellent team interaction skills along with demonstrated ability to work on a cross-functional team, manage internal/external team members, and influence the decisions of a team.
•   Ability to thrive in a fast paced environment focused on results and the common good.
•   High emotional intelligence and a focus on the common good.

Excellent salary and benefits package offered.

NO PHONE CALLS PLEASE.  PRINCIPALS ONLY
Regulus Therapeutics, Inc., is proud to be an EEO Employer.