Senior Staff Regulatory Specialist, Pharmaceutical R&D

Found in: Talent US C2 - 2 weeks ago

Cary, United States Mattson Resources Full time

Hybrid - Monday, Tuesday and Wednesday will be onsite at the R&D NPD facility
Focus will be on Pharmaceutical IND, NDA and CMC Module 3 - regulatory and submission work
FDA and International

MUST HAVE Pharma R&D Regulatory submission experience

 

What you will do

As a Senior Staff Regulatory Specialist, you will be exposed to a diverse product portfolio that includes pharmaceutical, cosmetic and medical device products. The ideal candidate will have strong project management skills including the ability to communicate effectively to a diverse set of stakeholders. In this role, you will:

 

• Prepare and author FDA INDs and NDAs, as well as annual reports.

• Assess the appropriate regulatory reporting mechanism using FDA regulations, guidance documents, and in-house policies upon review of Change Control Documentation.

• Assess and author amendments and supplements to product marketing applications.

• Provide regulatory guidance to other departments for planned changes.

• Provide a critical detailed review of technical documentation prior to FDA submission.

• Compile information and data pertaining to regulatory and project requirements including assessing needs; identifying the project’s critical factors; presenting decision-makers with options; and applying strategies.

• Communicate with regulatory agencies regarding pre-submission strategies/regulatory pathway development, submissions, and follow-up on submissions in review.

• Serve as partner to marketing, engineering, clinical and quality on project and product development teams.

• Improve awareness, visibility, and communication on regulatory requirements to support company goals and priorities.

 

What you need

• A minimum of a Bachelor’s Degree (B.S. or B.A.) in Science, Engineering or equivalent focus required.

• A minimum of 7 years of experience in an FDA or highly regulated industry required.

• A minimum of 5 years in a Regulatory Affairs role required.

• Must have pharmaceutical experience. Experience with medical device products would be a plus.

• Experience as primary liaison to regulatory authorities as well as experience authoring, reviewing and managing components of regulatory submissions.

Our benefits:

  • 12 paid holidays annually

  • Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program.

  • Financial benefits include Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.

  • Regulatory Affairs Manager

    Found in: Talent US C2 - 2 weeks ago

    Cary, United States Compass Consulting Full time

    Our client is a pharmaceutical company focused on developing and promoting products in the rare disease markets.Main Responsibilities:Regulatory Affairs Strategy and Management: Participate in R&D Core Teams (CTs) and Global Regulatory Teams (GRTs). Oversee annual budgeting for regulatory activities and manage activities against approved budget. Organize and...

  • Mobile C-Arm Clinical Applications Specialist

    2 weeks ago

    Cary, United States PSG Global Solutions Full time

    Description We're looking for a Mobile C-Arm Clinical Applications Specialist , working in Healthcare Systems and Services industry in Cary, North Carolina, United States . This is a role well suited to an ambitious professional, looking for the next step in their career. As a Clinical Application Specialist, you will be responsible for: Demonstrate products...

  • Chemist Job

    Found in: Talent US C2 - 2 weeks ago

    Cary, United States Arkema Full time

    We are seeking a Chemist to join Arkema as part of our Coating Resins business, based in Cary, NC. This position is responsible for providing analytical support to R&D, technical service, quality, and manufacturing of the Arkema Coating Resins business unit. The role requires hands on laboratory work to generate analytical data using a variety of analytical...

  • SENIOR ELECTRICAL ENGINEER

    Found in: Careerbuilder One Red US C2 - 3 days ago

    Cary, NC 27518, USA, United States NV5 Global, Inc. Full time

    OverviewNV5 is a provider of engineering and consulting services to public and private sector clients, delivering solutions through six business verticals: Testing, Inspection & Consulting; Infrastructure; Utility Services; Environmental Health Sciences; Buildings & Program Management; and Geospatial Technology. With offices nationwide and abroad, NV5 helps...

  • Senior Clinical Study Manager

    2 days ago

    Cary, United States Stryker Corporation Full time

    As a Senior Clinical Study Manager, you will assume overall responsibility for executing on the clinical evidence strategy for medical devices, pharmaceutical products, and cosmetics, and support development of this strategy. Create and execute clini Clinical, Manager, Clinical Research, Product Development, Clinic, Healthcare, Manufacturing

  • Hospital Sales Specialist

    Found in: Talent US C2 - 2 weeks ago

    Cary, United States CHIESI USA Full time

    Do you have a passion for sales and are results driven?? If the answer is yes, then this may be the job for you! Chiesi USA is looking for a highly motivated, performance driven sales specialist. We are a specialty pharmaceutical company focused on developing and promoting products for the hospital, adjacent specialty and rare disease markets. We are a B...

  • Senior I&C Engineer

    2 weeks ago

    Cary, United States DPS Group LLC Full time

    Summary DPS is looking for a driven, team-oriented, Senior Instrumentation & Controls Engineer that specializes in the design, development, and specifying of Instrumentation & Controls equipment, components, or systems for life-science, biopharmaceutical, and/or microelectronics/semiconductor facilities. The ideal candidate will have previous experience...

  • Senior Mechanical Engineer

    1 week ago

    Cary, United States Precis Engineering + Architecture Full time

    SENIOR MECHANICAL ENGINEER Cary, NC Description: Precis Engineering + Architecture (Precis) (www.precisengineering.com) offers comprehensive design services to our clients in the pharmaceutical, biotechnology, higher education, industrial, commercial, critical utility, and healthcare markets. Together, we design and create important buildings, facilities,...

  • Senior Mechanical Engineer

    Found in: Appcast Linkedin GBL C2 - 3 weeks ago

    Cary, United States Precis Engineering + Architecture Full time

    SENIOR MECHANICAL ENGINEERCary, NCDescription:Precis Engineering + Architecture (Precis) (www.precisengineering.com) offers comprehensive design services to our clients in the pharmaceutical, biotechnology, higher education, industrial, commercial, critical utility, and healthcare markets. Together, we design and create important buildings, facilities, and...

  • Senior Mechanical Engineer

    1 week ago

    Cary, United States Precis Engineering + Architecture Full time

    SENIOR MECHANICAL ENGINEER Cary, NC Description: Precis Engineering + Architecture (Precis) (www.precisengineering.com) offers comprehensive design services to our clients in the pharmaceutical, biotechnology, higher education, industrial, commercial, critical utility, and healthcare markets. Together, we design and create important buildings, facilities,...

  • Senior Director of Laboratory services

    2 days ago

    Cary, United States Azzur Group Full time

    DescriptionAzzur Lab is actively searching for a Senior Director of Lab services to serve as the site lead for our laboratory facility in Raleigh, NC. The ideal candidate will be a cross-functional leader capable of overseeing our Advanced Therapies and Microbiology teams. Core responsibilities of this role include overall site leadership, collaborating with...

  • Staff Medical Writer,

    2 days ago

    Cary, United States Stryker Corporation Full time

    As a Staff Medical Writer, you will work closely with cross-functional teams (Marketing, Research and Development, Regulatory, and Quality) to create literature reviews and reports to support global pharmacovigilance activities. In addition, you will Medical, Staff, Writer, Clinical Research, Healthcare, Remote, Manufacturing

  • Senior Project Manager

    2 weeks ago

    Cary, United States Infra-Rec Full time

    Job DescriptionJob DescriptionT&D Project Manager - Job DescriptionThe Senior Project Manager is responsible for the overall management of a project, from inception to completion. This includes developing project plans, managing budgets, scheduling resources, and coordinating with stakeholders. The Senior Project Manager must have a strong understanding of...

  • Facilities Technician

    Found in: Appcast Linkedin GBL C2 - 2 weeks ago

    Cary, United States Forrest Solutions Full time

    Location: Cary, NCContract Type: Full-timeSalary: $26-28/HRSummaryAre you looking to join an industry-leading entertainment and technology organization? The Facilities Technician will manage a range of needs within the global headquarters, including but not limited to managing preventative maintenance, troubleshooting equipment, and supervising contractors....

  • Facilities Technician

    Found in: Appcast US C2 - 2 weeks ago

    Cary, United States Forrest Solutions Full time

    Location: Cary, NCContract Type: Full-timeSalary: $26-28/HRSummaryAre you looking to join an industry-leading entertainment and technology organization? The Facilities Technician will manage a range of needs within the global headquarters, including but not limited to managing preventative maintenance, troubleshooting equipment, and supervising contractors....

  • Facilities Technician

    4 days ago

    Cary, United States Forrest Solutions Full time

    Location: Cary, NCContract Type: Full-timeSalary: $26-28/HRSummaryAre you looking to join an industry-leading entertainment and technology organization? The Facilities Technician will manage a range of needs within the global headquarters, including but not limited to managing preventative maintenance, troubleshooting equipment, and supervising contractors....

  • Senior Accounts Receivable Analyst

    2 weeks ago

    Cary, United States CAREER FOUNDATIONS, INC. Full time

    Job DescriptionJob DescriptionOur client is seeking a Senior Accounts Receivable Analyst to add to their team. The Accounts Receivable Lead is responsible for maintaining loyalty rebates process, calculation and posting of administrative fees, Credit Management, Collection and Dispute Analysis and reconciliation of general ledger accounts. Main...

  • Senior Structural Engineer

    2 weeks ago

    Cary, United States CareerBuilder Full time

    Summary DPS is looking for a Senior Structural Engineer, with a strong desire to work and learn in a collaborative environment. This role will be working directly with other senior and junior structural engineers and support the DPS internal teams on projects of all scales, from existing structure renovations to new buildings and expansions. This is a...

  • Senior Structural Engineer

    2 weeks ago

    Cary, United States DPS Group LLC Full time

    Summary DPS is looking for a Senior Structural Engineer, with a strong desire to work and learn in a collaborative environment. This role will be working directly with other senior and junior structural engineers and support the DPS internal teams on projects of all scales, from existing structure renovations to new buildings and expansions. This is a...

  • Group Account Director

    2 weeks ago

    Cary, United States CareerBuilder Full time

    In the journey of life, your career should make a difference. At Inizio Evoke, we come together-to do the best work, in the best possible place. We're all in. Because it's everyone's role to make health more human. The Opportunity: We are seeking a Group Account Director to join our dynamic agency. You will help us to reach our goals. You Will: Execution: Is...