Manager, Regulatory Affairs

ICU Medical Lake Forest , IL 60045

Posted 5 months ago


Develop and execute Global Regulatory Strategies and

Plans to assure that new Infusion Systems products and changes to existingproducts are developed in line with the global registration requirements oftargeted countries. Develop high quality US and global regulatory submissionsthat continue to build credibility with regulatory authorities. Obtainexpedient registration for assigned products. Maintain registrations of existing products in compliance withapplicable regulations

Essential Duties &Responsibilities

  • Develops regulatory strategies for development projects, design changes and manufacturing improvements, and analyzes risk vs. benefit in regulatory strategies to ensure successful review by global regulatory authorities.

  • Acts as Global Regulatory Affairs Lead on the cross functional teams developing and executing regulatory strategies, communicating regulatory requirements and ensuring they are incorporated into program deliverables

  • Manages the preparation of global registration packages and responses to requests for additional information. Negotiates submission data requirements and deliverable dates with internal technical teams. Author with team members, regulatory submissions for the software driven medication delivery systems.

  • Acts as a point person for regulatory agency interactions (either written or oral) including preparation of briefing packages and strategy for meetings, inspections, advisory committee meetings, and responses to agency letters pertaining to the assigned products.

  • Work with region and country RA counterparts to evaluate changes, and promotional materials for regulatory impact and to ensure compliance with applicable regulations.

  • Accurately describes these changes for ease of regulatory agency review.

  • Maintains awareness of global regulatory legislation and assesses its impact on business and product development programs.

  • Reviewand approve critical documents, seeking guidance when necessary.

  • Reviewtechnical reports and determine acceptability for regulatory submission.

  • Analyzes and interprets complex scientific data as well as global regulations.

  • Assesses scientific data provided for registration purposes to ensure it meets regulatory requirements.

  • Identifies gaps in product submission and executes plans to mitigate the risk to approval.

  • Summarizescomplex technical data.

  • Responsible for tracking and completion of assigned registration activities. Accountable for accuracy of work and meeting multiple, simultaneous deadlines. Missed registration deadlines or inaccurate registration packages can delay regulatory approvals, which can result in missed sales or regulatory action letters.

  • Follows scientific arguments, identifies regulatory scientific data needs and with supervision solves regulatory issues.

  • Presents scientific data effectively orally and in writing in a logical and persuasive manner.

  • Independentlyprovides daily regulatory support to new global product development teams andfor maintenance of commercial products.

  • Hasthe authority to prepare and submit complex regulatory submissions.

  • Directssubmission related activities by leading the team and motivating the staff tosuccessfully execute regulatory strategies.

  • Makesindependent judgments and decisions based on regulations and professionalexperience. Ensures alignment with

Regulatory Management as appropriate.

  • Reviewsregulatory commitments, strategy decisions, meeting strategies with regulatoryauthorities and changes to resource allocations with manager prior toexecution.

  • If responsibilities include people management, makes independent personnel decisions.

Knowledge,Skills & Qualifications

  • Abilityto manage multiple assignments, makes timely decisions, communicates concernsand self-motivated

  • Astutemanager and collaborative team leader. Able to establish clear objectives, planand organize work flow, etc., and bring right balance of leading by example andexerting influence to

  • Overall,brings a creative mind-set and innovative approach

  • Excellent oral and written communicationskills.

  • Excellent interpersonal skills.

  • Well-developed negotiating skills. Strongunderstanding of business needs

  • Proficiencyin Microsoft office including Word, Excel, Power Point and Outlook

Educationand Experience

  • Bachelor's Degree in related field required,Master's degree is preferred. R. Ph is a plus. A degree or experience inEngineering, Regulatory affairs or a related field

  • Ability to provide guidance to technicalteams, technical writing, and in problem solving technical issues as theyrelate to product development, manufacture and global registrations.

  • Proven strong record of preparing 510Ksubmissions and obtaining clearances in their name.

  • Advanced experience with assembling globaldossiers

  • Minimum of four years' experience inregulatory affairs to include drafting 510(k) or CE technical files.

  • Well-developed Experience working directlywith regulatory agencies. Soundknowledge of applicable portions of agency regulations and applicable guidancedocuments.

Minimum Qualifications

  • Must be atleast 18 years of age

  • Must passpre-employment drug screen and background check

Travel Requirements

  • Typically requires travel 5-20% ofthe time

Physical Requirements and Work Environment

  • This is largely a sedentary role.

  • This job operates in a professionaloffice environment and routinely uses standard office equipment.

Physical Requirements and Work Environment

  • While performing the duties of this job, the employee may berequired to sit or stand for long periods of time; depending on the machinethey are operating

We are an Equal Employment Opportunity Employer,Female/Minority/Veterans/Disabled/Sexual Orientation/Gender Identity.

See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Download the
LiveCareer app and find
your dream job anywhere

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Director Regulatory Affairs

Depomed, Inc.

Posted 5 days ago

VIEW JOBS 12/10/2018 12:00:00 AM 2019-03-10T00:00 Director, Regulatory Affairs Lake Forest, IL, United States Dec 12, 2018 Share: +1 on Google Tweet Share on Facebook Share on LinkedIn Apply Now Job Description Responsible for representing the Regulatory compliance voice on such matters and acts as an internal expert to advise on the FDA requirements while working closely with all stakeholders to reach consensus on approved messages and materials. This role will facilitate the generation of new, and revision of, product labeling with key local disciplines as well as external alliance partners and serve as the expert for the regulatory history for labeling and promotional communications with FDA. ESSENTIAL JOB FUNCTIONS * In collaboration with the VP, Regulatory Affairs, establishes regulatory strategy to support both development and commercial products. * Maintains an in-depth knowledge of regulatory requirements and guidance and assesses impact to the organization for advertising and promotions. * Provides education and training regarding requirements and works in collaboration with others to ensure compliance. * Functions as the "Regulatory Voice" for project teams, with a particular focus on Clinical Affairs. Provides clear Regulatory guidance and compliant pathways to regulatory approval * Functions as an FDA liaison on assigned projects. * Maintains a strong knowledge of electronic submission requirements and works in collaboration with regulatory operations to ensure team members follow templates and strategy for submission. * Med/Reg/Clin Affairs review and management of contracts - will streamline, manage and work with Legal to finalize contract approvals for all vendors, CRAs, consultants, etc. * Audit and Regulatory Compliance for Med Affairs/Regulatory and Clinical Affairs functions; investigator related studies, clinical trials, investigator meetings, other fee for service consultant arrangements * Systems/SOP development and training for drug safety reporting, et. al. Requirements EDUCATION AND EXPERIENCE * 8 - 12+ years' experience in regulatory affairs with first-hand involvement in maintaining and managing INDs and NDAs. * BA/BS degree or equivalent experience in related field required. Advanced degree preferred. * Advanced skills in using Microsoft Office Suite and Adobe programs. * Knowledge of FDA regulations and guidance as pertaining to post-approval clinical, nonclinical and submissions. * Lifecycle management and post-approval sNDA experience are highly desirable. * Experience with both development and commercial phases of the product lifecycle preferred. * Excellent verbal and written communication skills * Detail oriented, Decisive, and Adaptive to an evolving environment * Previous experience with managing others About Us THE COMPANY Assertio Therapeutic is a leading specialty pharmaceutical company committed to putting the Patient First in everything we do; with a focus on enhancing the lives of patients, families, physicians, providers and in payors through commercialization of products in the areas of neurology, orphan and specialty therapies. Assertio has a clear THREE PILLAR strategy for growth: MAINTAIN a strong/profitable NUCYNTA franchise through a commercialization agreement with Collegium, GROW the Neurology Business and BUILD a new Specialty Business through a recent Cosyntropin transaction. The company's strategy is to continue to identify, license and develop new products-that offer enhanced therapeutic options to patient populations that may be underserved by existing therapies. Assertio is an AA/EEO/Veterans/Disabled employer. Share: +1 on Google Tweet Share on Facebook Share on LinkedIn Depomed, Inc. Lake Forest IL

Manager, Regulatory Affairs

ICU Medical