Senior Associate, Regulatory Affairs

2 months ago

Greenville, United States Sun Pharmaceutical Industries, Inc. Full time

Responsible for preparing, reviewing and submitting to the Agency new ANDAs, NDAs, DMFs INDs, Supplements (PAS, CBE-30, CBE) and responses to FDA’s deficiencies pertaining to submissions. In addition, Senior Regulatory Affairs Associate is responsible for supporting a variety of activities in the department related to regulatory submissions and R&D requests, and supporting other departments within the organization. Make consistent, sound regulatory assessments of proposed changes requested by operations or R&D. Duties and responsibilities Responsible for preparation, compilation, review and submission of new NDAs, ANDAs, DMFs and INDs in eCTD format for FDA submission. Write related module (Mod 1) in CTD format for NDA, ANDA, DMF and IND. The submission content, style and architecture should adhere to electronic common technical document (eCTD) format. Follow current FDA and ICH guidelines and current cGMP and GLPs, pharmaceutical product testing requirements. Refer to USP requirements for chemical, physical and microbiological testing. Prepare, and submit INDs, NDAs, ANDAs, DMFs and ANADA annual reports, amendments and supplements in eCTD compliant format. Submissions should be prepared and reviewed for accuracy, consistency, and conformance to FDA and 21CFR regulations, ICH guidelines and in-house SOPs. Regulatory support of post-marketing commercial activities. Prepare and review supplements (PASs, CBE-30 and CBEs) for FDA submission. Review and approve change control forms for post approval activities of the product. Utilize regulatory and scientific skills to evaluate changes (such as changes to an approved product). For example: container closure system, manufacturing process, specifications, components and composition, and provide regulatory assessment based on current FDA and ICH guidelines, 21CFR regulations, USP requirements (for USP products and APIs). Evaluate prototype formulations for future filings based on IID database, RLD labeling, RLD patent(s) and exclusivities. Prepare Controlled Correspondences for FDA submission based on information provided by R&D department. The document should be prepared by utilizing scientific rational and supporting data provided by R&D department. Write SOPs. Maintain database. Other duties as assigned. Qualifications Three to five years of regulatory experience in pharmaceutical industry is required. Bachelor’s or Master’s Degree in a scientific discipline or equivalent. Strong written and verbal communication skills necessary. Ability to review regulatory and scientific submission documents for accuracy and adherence to regulatory requirements, noting deficiencies and inconsistencies. Ability to work effectively in a highly charged, fluid environment. Knowledge of Windows based software programs such as Word, Excel. Familiarity with FDA website is important in order to accomplish daily tasks. The presently-anticipated base compensation pay range for this position is $98,000 to $119,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time. The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.

  • Primary Care Physician

    4 weeks ago

    Greenville, North Carolina, United States Department Of Veterans Affairs Full time

    About the JobWe are seeking a highly skilled Primary Care Physician to join our team at the Department of Veterans Affairs. As a member of our healthcare team, you will be responsible for providing high-quality, patient-centered care to our nation's veterans.Key ResponsibilitiesClinical Care: Provide comprehensive primary care services to male and female...

  • Regulatory Compliance Testing Specialist

    1 month ago

    Greenville, United States TD Bank, N.A. Full time

    Description : Department Overview: U.S. Compliance Testing (USCT) is a centralized compliance testing team within the Compliance Department that conducts independent, risk-based compliance testing to assess the effectiveness of operational procedures and key controls over regulatory compliance.  The Regulatory Compliance Testing Specialist plays a...

  • Activities Associate

    2 months ago

    Greenville, United States Five Star Senior Living Full time

    Key Responsibilities The Opportunity The Life Enrichment (Activities) Associate Position assists the Life Enrichment Director in the delivery of recreational, evidence based programming to meet the needs of the residents in the community. What You'll Do Helps in the analysis of the community's resident population Helps with the writing of recreation program...

  • Tax Senior Associate

    4 weeks ago

    Greenville, United States Forvis Mazars, LLP Full time

    General informationNameTax - Senior AssociatePosting TitleTax Senior AssociateRef #2232274Date PublishedTuesday, April 9, 2024CityAshevilleStateNorth CarolinaCountryUnited StatesJob CategoryTaxOfficeAsheville NC (Forvis)Advertised LocationUS-NC-Asheville, US-SC-GreenvilleWorking timeFull TimeDescription & RequirementsAs a Tax Senior Associate at Forvis...

  • Senior Associate, Electrical Engineering

    3 weeks ago

    Greenville, United States L3Harris Technologies Full time

    Design and develop electrical systems for the integration of electronic equipment on military/commercial aircraft and ground stations. The design includes creating system wiring diagrams using the Capital Harness System tool as well as circuit breake Electrical Engineer, Electrical, Associate, Engineer, Systems Engineer, Senior, Technology

  • Audit Senior Associate

    4 weeks ago

    Greenville, United States Forvis Mazars, LLP Full time

    General informationNameAudit - Senior AssociatePosting TitleAudit Senior AssociateRef #2233673Date PublishedWednesday, September 11, 2024CityAshevilleStateNorth CarolinaCountryUnited StatesJob CategoryAudit/AssuranceOfficeAsheville NC (Forvis)Advertised LocationUS-NC-Asheville, US-SC-GreenvilleWorking timeFull TimeDescription & RequirementsOur firm provides...

  • Senior Audit Associate

    2 weeks ago

    Greenville, United States Rödl & Partner Full time

    Description Do you have audit experience in public accounting and are looking to grow in your career with an international firm dedicated to your success? Our growing Greenville, SC office is seeking a Senior Audit Associate to add to our firm. We are looking for the right individual who is dynamic, entrepreneurial, and career-oriented to join our team! Why...

  • Senior Patient Access Specialist

    4 weeks ago

    Greenville, South Carolina, United States Ensemble Health Partners Full time

    Senior Patient Access Specialist - Revenue Cycle ProfessionalCompany Overview:Ensemble Health Partners is a leading provider of technology-enabled revenue cycle management solutions for health systems, including hospitals and affiliated physician groups. They offer end-to-end revenue cycle solutions as well as a comprehensive suite of point solutions to...

  • SVP & Deputy General Counsel

    6 months ago

    Greenville, United States Prisma Health Full time

    Inspire health. Serve with compassion. Be the difference. Job Summary In coordination with the General Counsel for Prisma Health, the Deputy General Counsel is responsible for legal services across Prisma Health and its affiliates and serves as the legal advisor to the organization's senior management team throughout the Prisma Health system. This...

  • Physician- Greenville Primary Care

    2 months ago

    Greenville, NC, United States Department Of Veterans Affairs Full time

    Duties VA offers a comprehensive total rewards package. VHA Physician Total Rewards.Recruitment Incentive (Sign-on Bonus): Maybe authorized for highly qualified applicants.Education Debt Reduction Program (Student Loan Repayment): Learn more.EDRP Authorized:Former EDRP participants ineligible to apply for incentive. Contact Contact Caronda Slocum,...

  • Physician - Primary Care (GAP)

    1 month ago

    Greenville, NC, United States Department Of Veterans Affairs Full time

    Duties VA offers a comprehensive total rewards package. VHA Physician Total Rewards.Education Debt Reduction Program (Student Loan Repayment): Learn more.EDRP may be authorized:Former EDRP participants ineligible to apply for incentive. Contact Contact Caronda Slocum, caronda.slocum@va.gov, the EDRP Coordinator for questions/assistancePay: Competitive...

  • Associate Dean, Clinical Simulation

    1 month ago

    Greenville, United States Brody School of Medicine at East Carolina University Full time

    Primary Purpose of Organization Unit: The Interprofessional Clinical Simulation Program (ICSP) at the Brody School of Medicine (BSOM) provides access to simulation-based education for learners across the Health Sciences Campus and ECU Health Medical Center. The program collaborates closely with ECU Health Medical Center in offering educational activities to...

  • Senior Patient Access Specialist

    1 month ago

    Greenville, United States Ensemble Health Partners Full time

    Thank you for considering a career at Ensemble Health Partners! Ensemble Health Partners is a leading provider of technology-enabled revenue cycle management solutions for health systems, including hospitals and affiliated physician groups. They offer end-to-end revenue cycle solutions as well as a comprehensive suite of point solutions to clients across the...

  • Tax Senior Associate

    4 weeks ago

    Greenville, United States FORVIS Full time

    Description & Requirements As a Tax Senior Associate at Forvis Mazars, you value working closely with others to plan for the future and to help successful companies and their owners avoid surprises, coordinate tax strategies, and grow. You will provide authentic support to your teammates and clients and communicate regularly with them to understand their...

  • Activities Director/Director of Celebrations

    2 weeks ago

    Greenville, United States TerraBella Senior Living Full time

    TerraBella Senior Living is the proud operator of more than 30 plus, amenity-, care- and lifestyle-focused communities located throughout the Carolinas, Virginia, Kentucky, Georgia, and Tennessee. TerraBella communities together account for more than 2200 units and span a full spectrum of senior living and care options, including Active Independent Living,...

  • Associate Attorney

    3 months ago

    greenville, United States Gallivan, White & Boyd, P.A. Full time

    About the jobGallivan, White & Boyd, P.A. has an opportunity for an Associate Attorney to join our Insurance Coverage practice. Candidates must have excellent academic credentials and should possess strong writing, analytical, and oral advocacy skills. Three to five years of prior insurance coverage experience and current membership with the South Carolina...

  • Associate Attorney

    3 months ago

    Greenville, United States Gallivan, White & Boyd, P.A. Full time

    About the jobGallivan, White & Boyd, P.A. has an opportunity for an Associate Attorney to join our Insurance Coverage practice. Candidates must have excellent academic credentials and should possess strong writing, analytical, and oral advocacy skills. Three to five years of prior insurance coverage experience and current membership with the South Carolina...

  • Associate Attorney

    3 months ago

    greenville, United States Gallivan, White & Boyd, P.A. Full time

    About the jobGallivan, White & Boyd, P.A. has an opportunity for an Associate Attorney to join our Insurance Coverage practice. Candidates must have excellent academic credentials and should possess strong writing, analytical, and oral advocacy skills. Three to five years of prior insurance coverage experience and current membership with the South Carolina...

  • ADON - Assistant Director of Nursing (RN)

    2 months ago

    Greenville, United States Senior Living Communities Full time

    Find your new career with a team of HEROES, who are extraordinary people doing ordinary things for seniors. We are dedicated to giving back and supporting our team members, local community, and others worldwide. Come see why Cascades Verdae is certified as a Great Place to Work! Now accepting applications for an Assistant Director of Nursing (ADON) - RN....

  • ADON - Assistant Director of Nursing (RN)

    4 weeks ago

    Greenville, United States Senior Living Communities Full time

    Find your new career with a team of HEROES, who are extraordinary people doing ordinary things for seniors. We are dedicated to giving back and supporting our team members, local community, and others worldwide. Come see why Cascades Verdae is certified as a Great Place to Work! Now accepting applications for an Assistant Director of Nursing (ADON) - RN....