Job Description
We are seeking a Senior Director (Sr. Principal Scientist) Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help advance our pipeline and drive our strategic priorities.
Summary, Focus and Purpose
The Senior Principal Scientist | Regulatory Affairs Liaison is responsible for development and implementation of worldwide regulatory strategy for their assigned projects in the General Medicine therapeutic area, with a specific focus on development programs in Immunology, Neuroscience and/or Ophthalmology. The individual functions with a high degree of independence and provides regulatory oversight for assigned products, to optimize product labeling and obtain shortest time to approval by global regulatory agencies.
You will independently manage projects, functioning as the single, accountable, global point of contact on those projects and independently interact with Worldwide Regulatory Agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more company investigational and marketed drugs/biologics. Programs may be complex with more than one indication, formulation and/or have an external business partner.
Coordinates the preparation, submission and follow-up contact with regulatory agencies and/or subsidiaries for all applications and submissions and responsible for regulatory review and final approval for all submissions and associated documentation. Provides expertise as Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.
Key Functions
- Reports to Executive Director or Associate Vice President, General Medicine
- Works Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion
- Develops worldwide product regulatory strategies to optimize labeling and obtain shortest time to approval by regulatory agencies for multiple indications simultaneously
- Assesses regulatory/competitive landscape to establish global regulatory strategies that facilitate speed-to-market and the delivery of targeted product labeling
- Provide expert advice as the Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact for products within and external to GRACS on regulatory issues as they arise with the developmental compounds or marketed products throughout the entire life cycle of the drug
- Provide leadership to the Global Regulatory Team which coordinates cross-functional regulatory support for development programs and marketed products
- Review and provide final approval of local registration study protocols when needed to obtain marketing authorization in secondary markets
- Represents our company with external organizations through direct communication with the FDA, including telephone calls and e-mail; chair meetings between company and FDA; prepare our company teams for meetings with FDA at any phase of drug development
- Lead cross-functional efforts to prepare for advisory committees and may speak at the advisory committee
- Coordinate interactions with foreign agencies through Regulatory Affairs Europe and the subsidiary registration departments to support their interactions and provide strategic direction across multiple regions simultaneously
- Review and provide final approval of Worldwide Marketing Applications, Clinical Study Reports, protocols, Investigator Brochures before release from our company to external agencies and investigators
- Represent GRA within internal company committees to provide regulatory advice and approval according to the committee charters (including therapeutic area Document Review Committees, Product Development Team, Early Development Team, and label development team)
- Conducts initial IND/CSA content review and approval to facilitate initial approval by agencies for conduct of clinical trials
- Participate in regulatory due diligence activities for licensing candidate review
Education
- B.S. or M.S with a minimum of 10 years of relevant drug development experience with majority in regulatory or
- M.D. or PhD/PharmD with a minimum of 7 years relevant drug development experience with five years in regulatory
Experience | Skills | Knowledge
Required
- Ability to achieve optimal results with limited day-to-day direction from Therapeutic Area Lead
- Skilled/experienced in assessing global regulatory/competitive landscape to establish global regulatory strategies that facilitate speed to market while delivering targeted product labeling
- Strong verbal and written communication skills
Preferred
- Substantial experience with immunology, neuroscience and/or ophthalmology development programs
- Small and large molecule experience
- Substantial experience in Regulatory Affairs
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