![SGA](https://wjm.s3.amazonaws.com/aarp/uploads/%26no_logo..jpg)
Regulatory Affairs Senior Manager
2 weeks ago
Software Guidance & Assistance, Inc., (SGA), is searching for a Regulatory Affairs Senior Manager for a FULL TIME assignment with one of our premier Pharmaceutical Services clients in Hawthorne, NY.
Responsibilities:
US Agent for all Firm's products, responsible for communication between the FDA and manufacturing sites.
Communicate and follow-up status with FDA for any Chemistry, Bioequivalence and Patents issues and correspondences on both pending and approved applications
Lead, guide and train the CMC team to ensure highly qualified personnel that is able to perform to meet company KPO
Preparation, Review and filings of new ANDA, NDA, IND and DMF for the U.S. FDA in eCTD format.
Preparation, Review and filing of all post marketing activities which include, timely submission of Annual Reports, CPP, release of detained products at customs etc.
Respond to deficiencies related to Chemistry, Bioequivalence and Patent in timely manner.
Review and approve Prototype formulation during early drug development stages to be in compliance with Inactive Ingredient Database and FDA guideline.
Preparation, submission and monitoring of PLAIR activities, prior to new product launch
Manage regulatory correspondence mainly to CDER, FDA, User fee staff, drug listing and Board of Pharmacies for state licensing submissions.
Contact FDA and participate in Pre-IND and Pre-NDA meetings. Prepare, review and filing of the package for these meetings.
Communicate and follow-up with FDA for any issues, responses, status for pending and approved applications. Respond to FDA's request expeditiously.
Review and provide guidance for Citizen Petitions. Prepare, review and file suitability petitions and controlled correspondence.
Monitor FDA websites for new and/or updated guidance's and implement and guide the team, as required.
Review and approve all change controls from manufacturing sites, when required.
Provide guidance and advise management regarding improvement in CMC harmonization process of regulatory documentation at all manufacturing sites.
Active participation in Lesson learned process, derived from regulatory correspondences.
Support TA Labeling team, when required
Participate in decision making process with other applicable departments.
Prepare and evaluate performance of the individuals in the department.
Coordinate with global and local affiliates.
Required Skills:
MS in Life Sciences
4-5 years of proven experience in working with the FDA and managing regulatory team in the generic pharmaceutical industry.
Strong background in CMC aspects of drug product registration, knowledge of U.S. drug registration (NDA, ANDA, DMF & INDs) and with U.S. drug product labeling requirements.
Excellent verbal/written communication skills, computer skills and attention to detail.
Excellent teamwork abilities.
SGA is a technology and resource solutions provider driven to stand out. We are a women-owned business.
Our mission:
to solve big IT problems with a more personal, boutique approach. Each year, we match consultants like you to more than 1,000 engagements. When we say let's work better together, we mean it.
You'll join a diverse team built on these core values:
customer service, employee development, and quality and integrity in everything we do. Be yourself, love what you do and find your passion at work. Please find us at .
SGA is an Equal Opportunity Employer and does not discriminate on the basis of Race, Color, Sex, Sexual Orientation, Gender Identity, Religion, National Origin, Disability, Veteran Status, Age, Marital Status, Pregnancy, Genetic Information, or Other Legally Protected Status.
We are committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, and our services, programs, and activities.
Please visit our company to request an accommodation or assistance regarding our policy.-
Associate, Regulatory Affairs
2 weeks ago
Hawthorne, New York, United States Sun Pharma Full timeThe Associate, Regulatory Affairs - Labeling position is responsible for the preparation of various regulatory Labeling submissions.Area of Responsibility:Review and timely completion of labeling for ANDA dossiers for submissions and prepare and review response to labeling deficiencies to secure approval.Prepare and submit updated labeling in eCTD format to...
-
Absence Management Specialist
2 weeks ago
Hawthorne, New York, United States Reliance Standard Full timePosition OverviewAs a Claims Examiner at Reliance Matrix, you will serve as a crucial link between clients, employees, and healthcare providers. Your role involves ensuring efficient claims management processes to deliver top-notch service to claimants and clients. Responsibilities:Investigate and resolve claim issues in line with departmental and regulatory...
-
Analyst, Financial Planning and Analysis
2 weeks ago
Hawthorne, New York, United States Taro Pharmaceuticals U.S.A., Inc. Full timeAnalyst, Financial Planning and Highly visible corporate FP&A role to senior management of two multinational public companies. Coordinate consolidated Financial Planning & Analysis (FP&A) budgeting, forecasting, and reporting processes. Perform deep-dive modeling for various initiatives. Monitor trend vs. budget and prior forecasts for business, including...
-
Director of Engineering and R&D
2 weeks ago
Hawthorne, New York, United States Charles Kriston Group Full timeDirector of Engineering and R&D - Greater New York City area Become our client's Director of Engineering and R&D - it's your chance to put some serious industry experience to use Are you interested in joining an organization with deep roots, a great culture, and who is a fast-paced leader of package inspection? Leverage your understanding of people, sensory...
-
Marketing and Communications Director
2 weeks ago
Hawthorne, New York, United States Touro University New York Full timeOverview The Marketing and Communications Director assists with elevating and enhancing the image and identity of the Touro College of Dental Medicine (TCDM) at New York Medical College (NYMC), strengthening its reputation among key stakeholders, supporting enrollment, facilitating the student experience and furthering development goals while applying...
-
Clinical Practice Supervisor
2 weeks ago
Hawthorne, New York, United States WMCHealth Full timeClinical Practice Supervisor Company: WMC Advanced Physician Services PC City/State:Hawthorne, NY Category: Executive/Management Department: Gyn ONC Union: No Position: Full Time Hours: M-F 830-5 Shift: Day Req #: 37094 Posted Date:Sep 29, 2023 Hiring Range:$31.69-$39.83 Apply Now External Applicant link ) Internal Applicant link Job Details:Job Summary:...
-
analyst - Full Time
2 weeks ago
Hawthorne, New Jersey, United States Sun Pharma (Taro Pharma) Full timeATTN:COMPANY EMPLOYEES – THIS JOB OPPORTUNITY IS ELIGIBLE FOR INCENTIVES OFFERED UNDER THE EMPLOYEE REFERRAL PROGRAM Analyst, Financial Planning and Analysis: Highly visible corporate FP&A role to senior management of two multinational public companies. Coordinate consolidated Financial Planning & Analysis (FP&A) budgeting, forecasting, and reporting...
-
Senior Manager, Regulatory Affairs
2 weeks ago
Hawthorne, United States Sun Pharmaceutical Industries Full timeThis position will serve as the company US Agent and a contact point between the FDA and Taro sites. Responsible to communicate with FDA for all regulatory issues/questions and provide regulatory guidance to internal constituents. It will lead a team of Regulatory Associates and Sr. Regulatory Associates managing, preparing and filing of wide variety of...
-
Senior Manager, Regulatory Affairs
4 weeks ago
Hawthorne, United States Sun Pharmaceutical Industries Full timeThis position will serve as the company US Agent and a contact point between the FDA and Taro sites. Responsible to communicate with FDA for all regulatory issues/questions and provide regulatory guidance to internal constituents. It will lead a team of Regulatory Associates and Sr. Regulatory Associates managing, preparing and filing of wide variety of...
-
Senior Manager, Regulatory Affairs
3 weeks ago
Hawthorne, United States Sun Pharma Full timeThis position will serve as the company US Agent and a contact point between the FDA and Taro sites. Responsible to communicate with FDA for all regulatory issues/questions and provide regulatory guidance to internal constituents. It will lead a team of Regulatory Associates and Sr. Regulatory Associates managing, preparing and filing of wide variety of...
-
Senior Manager, Regulatory Affairs
1 month ago
Hawthorne, United States Sun Pharmaceutical Industries Full timeThis position will serve as the company US Agent and a contact point between the FDA and Taro sites. Responsible to communicate with FDA for all regulatory issues/questions and provide regulatory guidance to internal constituents. It will lead a team of Regulatory Associates and Sr. Regulatory Associates managing, preparing and filing of wide variety of...
-
Senior Manager, Regulatory Affairs
3 weeks ago
Hawthorne, United States Sun Pharma Full timeThis position will serve as the company US Agent and a contact point between the FDA and Taro sites. Responsible to communicate with FDA for all regulatory issues/questions and provide regulatory guidance to internal constituents. It will lead a team of Regulatory Associates and Sr. Regulatory Associates managing, preparing and filing of wide variety of...
-
Senior Manager, Regulatory Affairs
2 weeks ago
Hawthorne, California, United States Sun Pharmaceutical Industries Full timeThis position will serve as the company US Agent and a contact point between the FDA and Taro sites. Responsible to communicate with FDA for all regulatory issues/questions and provide regulatory guidance to internal constituents. It will lead a team of Regulatory Associates and Sr. Regulatory Associates managing, preparing and filing of wide variety of...
-
Senior Manager, Regulatory Affairs
3 weeks ago
HAWTHORNE, United States Sun Pharma (Taro Pharma) Full timeThis position will serve as the company US Agent and a contact point between the FDA and Taro sites. Responsible to communicate with FDA for all regulatory issues/questions and provide regulatory guidance to internal constituents. It will lead a team of Regulatory Associates and Sr. Regulatory Associates managing, preparing and filing of wide variety of...
-
Senior Manager, Regulatory Affairs
3 weeks ago
Hawthorne, United States Sun Pharma (Taro Pharma) Full timeJob DescriptionThis position will serve as the company US Agent and a contact point between the FDA and Taro sites. Responsible to communicate with FDA for all regulatory issues/questions and provide regulatory guidance to internal constituents. It will lead a team of Regulatory Associates and Sr. Regulatory Associates managing, preparing and filing of wide...
-
Senior Manager, Regulatory Affairs
4 weeks ago
Hawthorne, United States Sun Pharma (Taro Pharma) Full timeThis position will serve as the company US Agent and a contact point between the FDA and Taro sites. Responsible to communicate with FDA for all regulatory issues/questions and provide regulatory guidance to internal constituents. It will lead a team of Regulatory Associates and Sr. Regulatory Associates managing, preparing and filing of wide variety of...
-
Associate, Regulatory Affairs
2 weeks ago
Hawthorne, United States Sun Pharma Full timeThe Associate, Regulatory Affairs - Labeling position is responsible for the preparation of various regulatory Labeling submissions. Area of Responsibility: Review and timely completion of labeling for ANDA dossiers for submissions and prepare and review response to labeling deficiencies to secure approval.Prepare and submit updated labeling in eCTD format...
-
Associate, Regulatory Affairs
3 weeks ago
Hawthorne, United States Sun Pharma (Taro Pharma) Full timeJob DescriptionThe Associate, Regulatory Affairs - Labeling position is responsible for the preparation of various regulatory Labeling submissions. Area of Responsibility: Review and timely completion of labeling for ANDA dossiers for submissions and prepare and review response to labeling deficiencies to secure approval.Prepare and submit updated labeling...
-
Associate, Regulatory Affairs
3 weeks ago
HAWTHORNE, United States Sun Pharma (Taro Pharma) Full timeThe Associate, Regulatory Affairs - Labeling position is responsible for the preparation of various regulatory Labeling submissions. Area of Responsibility: Review and timely completion of labeling for ANDA dossiers for submissions and prepare and review response to labeling deficiencies to secure approval.Prepare and submit updated labeling in eCTD format...
-
Associate, Regulatory Affairs
3 weeks ago
Hawthorne, United States Sun Pharma (Taro Pharma) Full timeThe Associate, Regulatory Affairs - Labeling position is responsible for the preparation of various regulatory Labeling submissions. Area of Responsibility: Review and timely completion of labeling for ANDA dossiers for submissions and prepare and review response to labeling deficiencies to secure approval.Prepare and submit updated labeling in eCTD format...
-
Senior Manager, Regulatory Affairs
4 weeks ago
Hawthorne, NY, United States Sun Pharma (Taro Pharma) Full timeThis position will serve as the company US Agent and a contact point between the FDA and Taro sites. Responsible to communicate with FDA for all regulatory issues/questions and provide regulatory guidance to internal constituents. It will lead a team of Regulatory Associates and Sr. Regulatory Associates managing, preparing and filing of wide variety of...
-
Associate, Regulatory Affairs
3 weeks ago
Hawthorne, United States Sun Pharma Full timeThe Associate, Regulatory Affairs - Labeling position is responsible for the preparation of various regulatory Labeling submissions. Area of Responsibility: Review and timely completion of labeling for ANDA dossiers for submissions and prepare and review response to labeling deficiencies to secure approval. Prepare and submit updated labeling in eCTD...
-
Associate, Regulatory Affairs
4 weeks ago
Hawthorne, NY, United States Sun Pharma (Taro Pharma) Full timeThe Associate, Regulatory Affairs - Labeling position is responsible for the preparation of various regulatory Labeling submissions. Area of Responsibility: Review and timely completion of labeling for ANDA dossiers for submissions and prepare and review response to labeling deficiencies to secure approval. Prepare and submit updated labeling in eCTD...
-
Senior Manager, Regulatory Affairs
3 weeks ago
Hawthorne, NY, United States Sun Pharma (Taro Pharma) Full timeThis position will serve as the company US Agent and a contact point between the FDA and Taro sites. Responsible to communicate with FDA for all regulatory issues/questions and provide regulatory guidance to internal constituents. It will lead a team of Regulatory Associates and Sr. Regulatory Associates managing, preparing and filing of wide variety of...
-
Associate, Regulatory Affairs
3 weeks ago
Hawthorne, NY, United States Sun Pharma (Taro Pharma) Full timeThe Associate, Regulatory Affairs - Labeling position is responsible for the preparation of various regulatory Labeling submissions. Area of Responsibility: Review and timely completion of labeling for ANDA dossiers for submissions and prepare and review response to labeling deficiencies to secure approval.Prepare and submit updated labeling in eCTD format...
-
Senior Manager, Product Management
3 days ago
Hawthorne, United States Sun Pharmaceutical Industries, Inc. Full timePress Tab to Move to Skip to Content Link Select how often (in days) to receive an alert: Create Alert Title: Senior Manager, Product Management Company: Sun Pharmaceutical Industries, Inc (USA) Lead the marketing, product launch and forecasting efforts for the generics commercial team. This position will generate sales analytics, product management and...
-
Senior Project Manager
3 weeks ago
Hawthorne, United States Pfister Energy Full timePfister Energy, Inc. is a renewable energy company providing innovative power solutions and energy efficiency measures for commercial, industrial, and institutional facilities. We are a national developer and EPC of turnkey renewable energy, energy efficiency, and on-site distributed power generation systems, with over 500 megawatts (MW) of solar electric...