Regulatory Affairs Manager

Location
Fort Worth, TX, United States
Posted
Apr 14, 2021
Ref
1071
Required Education
Masters Degree/MBA
Position Type
Full time
COMPANY DESCRIPTION:

Santen is a specialized pharmaceutical company with a 130-year heritage focused exclusively on ophthalmology. With sales in over 60 countries, Santen’s 4,000 global employees work to deliver life-changing therapies that make hope a reality for people facing vision impairment and loss. Santen Inc., located in Emeryville, CA (North America HQ), contributes important research & development and commercialization efforts. This office is home to about half of our 300-total staff in North America, including our Toronto, Canada site and our recent acquisitions of Eyevance Pharmaceuticals (Fort Worth, TX) and InnFocus (Miami, FL).

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

ABOUT THE POSITION:

The Regulatory Affairs Manager plays a significant role in supporting US and non-US submission related activities. This position will serve as the regulatory consultant to project teams and governmental regulatory agencies, and interacts with internal and external personnel on matters often requiring coordination between organizations. The position represents the organization as a key contact on contracts and/or projects.

ESSENTIAL DUTIES AND KEY DELIVERABLES:
  • Responsible for drug establishment registration and drug product listing activities.
  • Maintain FDA, EMA, ICH and related statutory guidelines.
  • Interact with regulatory agencies on projects.
  • Monitor and improve regulatory compliance/tracking systems.
  • Leads regulatory strategy development and implementation planning, including recommending changes for labeling, manufacturing, marketing and clinical protocols.
  • Provides guidance and recommendations on regulatory and quality issues as required.
  • Reviews all product labeling for assigned products to ensure compliance with regulatory requirements.
  • Reviews all document control change requests for regulatory consequences.
  • Provides advice to clinical teams on appropriate regulations and interpretations.
  • Coordinates reviews and provides input to reports for submission.
  • Develop and maintain regulatory affairs department procedures.
  • Comply with applicable FDA and international regulatory laws/standards and the Santen Business Code of Conduct.

QUALIFICATIONS:
  • BA/BS in chemistry, biology, engineering or related pharmaceutical field required; advanced degree preferred.
  • Five to eight (5-8) years of pharmaceutical/biotech industry experience, and three to five (3-5) years of regulatory strategy experience.
  • Regulatory Affairs Certification preferred.
  • Working knowledge of US regulations and guidelines.
  • Pharmaceutical industry experience preferred.
  • Excellent verbal and written communications skills required.
  • Must be detail oriented.
  • Experience compiling NDAs and document packages for commercial products required.
  • Knowledge of regulatory support requirements for pre-approval inspections highly recommended.
  • Must be computer literate. Proficiency in MS Office is preferred.
  • Ability to communicate effectively across all organizational levels, including with Santen Inc. management.
  • Previous work experience working cross-culturally, especially with Japanese companies, a plus.
  • Ability to work independently as well as collaboratively across functions.
  • Demonstrated track record of successfully implementing a project plan.
  • Highly developed understanding of drug development.
  • Must be able to work effectively in a fast-paced work environment, managing multiple priorities and tasks.

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