Deputy Director, Regulatory Affairs

Clayton, NC, United States
Nov 11, 2020
Bio NC
Required Education
Bachelors Degree
Position Type
Full time
This position is a leadership role within the Regulatory Affairs department. This position is responsible for managing the Regulatory Operations functions for all of North America, specifically dealing with eCTD submissions, NeeS and paper submissions when required.

Primary Responsibilities for the Role:
• Manage a team of personnel to support global submission processes via eCTD, NeeS or

paper submissions.
• Manage the submission load for licensed and development products to support project timelines and meet business objectives.
• Act as the technical lead for all regulatory operations systems (e.g. document management,

publishing software, submission planning/tracking system).
• Proven ability to interpret regulatory guidelines/requirements for eCTD publishing and ensure compliance with global standards.
• Ensure priority conflicts, resource issues and deviations from the submission project plan are proactively identified and mitigated or resolved.
• Provide sound technical regulatory guidance to management on projects/changes with a solution

oriented focus with regard to eCTD regulations/requirements.
• Ability to troubleshoot validation concerns, software issues and any other technical issues that may arise and effectively liaison with IT staff.

Knowledge, Skills and Abilities:
• Strong leadership and management skills for projects/personnel.
• Proven ability to lead both domestic and global projects.
• Strong technical background, project management and roll out experience.
• Proven ability to adapt to changing priorities and timelines.
• Proven ability to prioritize work and allocate resources in accordance with changing business objectives.
• Expert and thorough understanding of global product registration requirements from a publishing perspective.
• Proven ability to collaborate on cross-functional teams with Quality, Manufacturing, R&D and others as needed.
• Excellent oral and written communication skills and proven ability to lead technical discussions internally as well as with health authorities when needed.

Requirements: Bachelor's degree in a relevant discipline (such as science and technology are preferred). Minimum of 8 years of directly related/industry experience. Of the experience, a minimum of 3 years of supervisory experience is required.

Shift: Day

Location: Clayton, NC

Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Frequently walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations and frequently travels within the United States. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others, relates sensitive information to diverse groups. Ability to apply abstract principles to solve complex conceptual issues. Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.

EEO Minorities/Women/Disabled/Veterans