Skip to main content

This job has expired

You will need to login before you can apply for a job.

Senior Regulatory Affairs Specialist

Employer
Santen, Inc.
Location
Emeryville, CA, United States
Start date
Sep 4, 2019

View more

Discipline
Clinical, Regulatory, Regulatory Affairs
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay
Send job

Job Details

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 qualified individual 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 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:

Core compentencies, education, and experience.
  • 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


For more information about our company and the work experience, please visit www.santenusa.com

Company

Santen is a global pharmaceutical and medical device company focused solely on ophthalmology. We’re committed to serving serious unmet needs by developing innovative solutions that protect vision and, in turn, preserve quality of life for people around the world.

Santen USA, located in Emeryville, CA, is an important part of our ophthalmic research, development, and commercialization efforts worldwide and the home of our regional business teams. By leveraging our deep industry knowledge and a network of external partners, we aim to deliver game-changing therapies and make hope a reality for people facing vision impairment and loss.

Our deep roots start in Japan, Santen’s worldwide headquarters, where the company began in 1890. Since then, Santen has become an established leader in the Asian and European prescription ophthalmology marketplaces and continues to expand across global markets, including the United States. Today, Santen employs more than 4,000 people worldwide and sells specialty ophthalmic products in more than 60 countries.

With a clear focus on vision, we aim to deliver the highest quality products, to act with integrity, to earn the trust of our partners and customers, and to deliver sight-saving innovations to physicians and patients who are waiting for them.
 

 

Company info
Website
Location
6401 Hollis Street
Emeryville, CA 94608
 United States
Send job

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert