Senior Regulatory Affairs Specialist

Location
Emeryville, CA, United States
Posted
Sep 06, 2020
Ref
oNz8cfwq
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
COMPANY DESCRIPTION:

At Santen, we're innovating therapies to improve the quality of life for patients worldwide. Our single focus in ophthalmology enables us to challenge unmet needs in the field-through passionate research, successful collaboration, and clarity of commitment. With over 130 years of investigative insight, Santen remains committed to the discovery, exploration, and development of ophthalmic therapies. As a global company, Santen is expanding to accommodate new and evolving initiatives in ophthalmic research, regulatory management, production, marketing, or distribution. Our clinical development network spans three continents, with centers in Europe, Japan, and the United States.

We are in search of top talent to help us meet our aggressive and important goals.

ABOUT THE POSITION:

The Senior RA Specialist, will, under appropriate supervision, manage Regulatory Affairs activities for designated projects, prepare routine regulatory submissions, and perform regulatory research and regulatory intelligence as needed.

ESSENTIAL DUTIES AND KEY DELIVERABLES:
  • Responsible for the coordination, preparation, review and authoring of regulatory documents for regulatory submissions; including NDAs, new Marketing Applications (global), post approval supplements, variations and/or notifications, briefing documents for health authority meetings, new Clinical Trial Applications (CTAs, INDs,) annual reports, RTQ's, periodic safety updates and amendments
  • Liaise with the appropriate team members to shape and review content of documents, and to follow up with other functional groups for materials needed for document completion
  • Support development of global regulatory strategy for the development projects or marketed products
  • Represent global regulatory affairs in the project core team or as US regulatory representative in the global regulatory sub-team
  • Maintain awareness of FDA, EMA, ICH and related guidelines and communicates new regulatory requirements to department colleagues and regulatory colleagues
  • Functions as regulatory advisor for project teams and other departments
  • Interacts with regulatory agencies on projects

QUALIFICATIONS:
  • Prior NDA experience preferred
  • BA/BS in a scientific, healthcare or related field; advanced degree (MS, Ph.D. or, Pharm.D) preferred
  • 2-5 years of relevant regulatory affairs and drug development experience or equivalent biopharmaceutical experience with a strong emphasis on regulatory affairs and drug development
  • RAC certification is a plus
  • Working knowledge of US regulations and guidelines and understanding of EU and Japanese regulations
  • Ability to effectively interpret guidances and provide recommendation to key stakeholders
  • Speaks and writes clearly and persuasively; responds well to questions; demonstrates strong group presentation skills; participates in meetings
  • Must be detail oriented
  • Adapts to changes in the work environment; manages competing demands; changes approach or method to best fit the situation; Able to deal with delays, or unexpected events.
  • Able to multitask and prioritize
  • Team player with excellent interpersonal skills
  • Must be computer literate and proficiency in MS Office is preferred
  • Able to communicate with Management
  • Possesses strong project management skills
  • Exhibits proofreading, editing and authoring skills
  • Understands drug development