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Manager, Regulatory Affairs

Employer
Assertio Therapeutics, Inc.
Location
Lake Forest, IL, US
Start date
Oct 21, 2019

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Discipline
Regulatory, Regulatory Affairs
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioMidwest
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Job Details

Responsible for the management and implementation of regulatory activities to maximize and maintain the company product portfolio. The position is responsible for clinical, nonclinical, post-approval regulatory affairs.

Responsibilities

Essential Job Function
  • In collaboration with the Director, Regulatory Affairs, establishes regulatory strategy to support development and commercial products.
  • Provide support in compiling routine submissions, including but not limited to: annual reports, labeling submissions, OPDP submissions, meeting requests, SPL, and investigator updates.
  • Maintains an in-depth knowledge of regulatory requirements and guidance and assesses impact to the organization.
  • Provide support to project teams as directed to meet filing objectives and department needs.
  • Functions as the "Regulatory Voice" for project teams. Provides clear Regulatory guidance and compliant pathways to regulatory approval.
  • Manages regulatory submissions, including but not limited to INDs, IND amendments, NDAs, and NDA supplements. Ensures team members understand the requirements for submissions and ensures all company submission timelines are met. Works with external vendors to affect FDA submissions.
  • Functions as an FDA liaison on assigned projects.

Additional Responsibilities/Duties
  • Completion of assigned tasks with a high level of quality within departmental and company timelines.
  • Other duties as assigned, which may include assisting other functional areas, on an as needed basis.


Qualifications

Education and Experience
  • BA/BS degree in related field.
  • Must be authorized to work in the U.S. on a permanent basis without sponsorship in the future.
  • 3+ years of experience working in regulatory affairs/operations. Lifecycle management and post-approval sNDA experience is highly desirable.
  • Knowledge of FDA regulations and guidances.
  • Excellent verbal and written communication skills.
  • Excellent attention to detail (including proofreading skills.
  • Outstanding interpersonal and effective task planning / coordination skills.
  • Strong teamwork, negotiation and influencing skills.
  • Advanced computer skills in a Windows environment, including Microsoft Office, Adobe Acrobat, and EDMS.


Skills and Abilities
  • Outstanding interpersonal and effective task planning / coordination skills.
  • Strong teamwork skills.
  • Completion of assigned tasks with a high level of quality within departmental and company timelines.
  • Ability to learn on the go and obtain the skills needed to work within a technical environment.
  • Strong communication and organization skills with attention to detail.
  • Excellent verbal and written communication skills.
  • Detail oriented, Decisive, and Adaptive to an evolving environment.


Assertio Competencies Include
  • Decisions and Judgment : Completing assigned tasks by gathering relevant information systematically and considering a broad range of issues or factors when making decisions.
  • Ownership and Initiative : Assumes personal ownership and accountability for business results and solutions. Organizes work based on company/department goals. Develops alternative strategies when confronted with obstacles. Plans and organizes work so that timelines are met or exceeded.
  • Communication Skills : Expresses ideas and information effectively and constructively. Provides accurate and timely information to others within the department and across functional groups. Demonstrates attention to and understanding of others' comments, questions, and views.


Physical/Mental Demands

PHYSICAL DEMANDS:
  • Sitting - 80%
  • Standing/ Walking - 20%
  • Repetitive motion: Substantial movements of the wrists, hands, and or fingers for sustained periods of time. Approximately 6-hours of keyboarding per day.
  • Visual Requirements: Able to see and read PC screens and read fine print.
  • Lifting: Raising objects under 15 pounds from a lower to a higher position or moving objects horizontally.

MENTAL REQUIREMENTS:
  • Ability to understand, remember, and apply oral and/or written instructions or other information.
  • Ability to understand, remember and communicate routine, factual information.
  • Ability to organize thoughts and ideas into understandable terminology.
  • Ability to organize and prioritize own work schedule.
  • Able to complete forms, use existing form letters and conduct routine oral communication.
  • Able to compose letters, outlines, memos and basic reports, and to orally communicate technical information.
  • Ability to count accurately.

Accommodations for Applicants with Disabilities

Assertio is proud to create a culture of inclusion and diversity and be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.

We provide reasonable accommodations to qualified applicants with disabilities and to disabled veterans in accordance with the ADA. If you require a reasonable accommodation for any part of the application process due to a medical condition or disability, please email hr@assertiotx.com or call 224-441-6867 for assistance.

Company

Assertio reflects an aspirational mindset that is forward thinking, energetic, and entrepreneurial in spirit. The Assertio mission of advancing patient care is reflected in our three-pillar strategy:

Maintain
Grow
Build

Maintain

In December 2017, the Company announced the signing of a definitive Commercialization Agreement with Collegium Pharmaceutical under which Collegium will commercialize the NUCYNTA pain franchise and Assertio will receive a royalty rate on all NUCYNTA revenues based on certain net sales thresholds.

Our long-term strategy is to continue to identify, license, develop and market distinctive products that offer enhanced therapeutic options for patients in need—all while maintaining the highest ethical standards in all our business practices.

We have developed and are licensing Acuform® technology, a patented oral delivery technology that allows for targeted, extended release of compounds into the upper GI tract. Acuform is currently utilized in four marketed products, including NUCYNTA ER and Gralise. To date, we’ve also licensed Acuform to six partners

Grow

We currently market three FDA-approved products for various neurological conditions.

Build

We have created a new specialty products business unit, with the objective of assembling a portfolio of specialty/orphan drugs that address the unmet needs of patients, physicians and payers. Our initial focus is the development of Cosyntropin (synthetic ACTH depot), a unique, late-stage product that, upon approval, will provide U.S. patients, physicians and payers with an alternative option.

NASDAQ: ASRT

Company info
Website
Phone
224-419-7106
Location
100 South Saunders Road, Suite 300
 Lake Forest
Illinois
60045
US
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