Job Description :
Sr. Manager, Regulatory Affairs
San Rafael, CA
6 Months
Duties: This position is responsible for the management, coordination, and preparation of a variety of global regulatory submissions for products in several therapeutic indications.
Proactively managing Chemistry, Manufacturing & Controls (CMC) aspects of one or more global clinical programs including overseeing preparation and submission of global CMC submissions, including clinical trial and marketing applications; ensure that CMC content is complete and meets all relevant requirements.
Evaluating proposed manufacturing changes for global impact to ongoing and existing filings, and providing strategic regulatory guidance for optimal implementation of changes.
Researching and interpreting global CMC regulations and provide regulatory guidance to the Quality, Manufacturing, Process Development and other functional groups within the Technical Operations organization.
Representing the Regulatory Affairs CMC function on assigned cross-functional project teams.
Managing interactions with global regulatory authorities for assigned projects to ensure acceptance, rapid review and approval of marketing applications, supplements/variations, clinical trial applications and other submissions which present CMC information.
Developing excellent relationships with internal functional groups, contract manufacturing organizations, and corporate partners.
Skills: Required Skills:
At least 8years of experience in Regulatory Affairs or related discipline in the pharmaceutical or biotechnology industry (preferably with exposure to both development and commercial phases of product lifecycle
Experience in management and filing of marketing applications, supplements, and/or Variations for pharmaceutical or biologic products in the U.S. and/or Europe.
Experience in assessing post-marketing changes.
Proven ability to lead cross functional CMC teams on projects and sub-teams.
Thorough understanding of relevant CMC drug development regulations and guidelines.
Outstanding interpersonal and communication (written and verbal) skills is required.
Able to work in a matrix team environment, such as cross-functional groups in Quality and Manufacturing, and including contractors, partners, and CRO''s in the international markets.
Proficiency with standard software programs (e.g., Word
Desired Skills:
Project management skills are a plus.
Experience with coaching, training and mentoring team members.
Proven ability to successfully interact with Regulatory Authorities.
Strong background in chemistry, molecular biology, or similar is desirable
Education:
Bachelor''s degree in biology or other life sciences discipline, advanced degree preferred (MS, PhD, PharmD)