Director, Regulatory Affairs, Labeling/Ad/Promo

Employer
Versartis
Location
Menlo Park, CA
Posted
Aug 06, 2017
Executive Administration Jobs
C-Level & Executive Directors
Jobs Outside Higher Education
Other Jobs Outside Higher Education
Institution Type
Outside Academe


Job Description

Description

Director, Regulatory Affairs, Labeling/Ad/Promo will develop and lead the regulatory activities and processes related to labeling development, advertising and promotion review for Versartis products and indications. The successful candidate will ensure that labeling, advertising, and promotional materials meet regulatory requirements and company standards. This position will serve as the lead regulatory affairs representative on the Versartis PRC.

Duties and Responsibilities - Essential Functions:

• Lead the development of company's product labeling and related materials, working closely with Medical, Marketing, and other company representatives

• Provide regulatory leadership and guidance to the marketing team during the development, review, and approval of promotional and advertising materials

• Review and approve non-promotional items such internal training documents and internal communications

• Develops collaborative relationships with internal stakeholders, external regulatory agencies, and experts

• Provide a leadership role on the promotional review committee (PRC) for regulatory review and internal approval of all product and advertising materials

• Help ensure alignment of development and commercial objectives

• Provide input on promotion implications of proposed clinical study designs, and draft publications, as appropriate

• Maintains up-to-date knowledge of laws, regulations and other communications issued by regulatory authorities as they relate to product labeling, promotional materials, and advertising

• Other duties and responsibilities as assigned

Requirements:

• Minimum BA/BS in a scientific discipline, advanced degree preferable

• Minimum 10 years of Regulatory Affairs experience, with at least 5 years supporting labeling development, and/or advertising/promotion review

• Strong, proactive, strategic thinking and leadership skills

• Strong interpersonal skills with an ability to communicate with people at all levels of an organization

• Proven negotiation, facilitation, and influencing skills

• Excellent verbal, written, organizational and time management skills and attention to detail

• Teamwork, problem-solving ability, customer/patient focus and quality oriented



Company Description
Versartis, Inc. is an endocrine-focused biopharmaceutical company initially developing somavaratan, a novel, long-acting form of recombinant human growth hormone in late-stage clinical trials for the treatment of GHD in children and adults. Somavaratan is intended to reduce the burden of daily injection therapy by requiring significantly fewer injections, potentially improving adherence and, therefore, treatment outcomes. For more information on Versartis, visit www.versartis.com.


Menlo Park, CA

dee7273f8

Fri, 4 Aug 2017 16:37:10 PDT

PI98954001