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Community affairs • cary nc

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Sr. Manager, Regulatory Affairs

Sr. Manager, Regulatory Affairs

ChiesiCary, NC, United States
[job_card.full_time]
Based in Parma, Italy, Chiesi is an international research-focused biopharmaceutical group with 90 years' experience, operating in 31 countries. More than 7,000 employees across the group are united...[show_more][last_updated.last_updated_30]
Assoc Director, Medical Affairs

Assoc Director, Medical Affairs

Gilead Sciences, Inc.Raleigh, NC, United States
[job_card.full_time]
Assoc Director, Medical Affairs.United States - North Carolina - Raleigh Medical Affairs Regular.Lead the implementation of a portfolio of technologies and platforms that enable business process an...[show_more][last_updated.last_updated_variable_days]
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Community Manager

Community Manager

Continental RealtyRaleigh, NC, US
[job_card.full_time]
Position : Community Manager for.Mary’s Square North – Raleigh, NC.Mary’s Street - 134 units.Mary’s Street - 65 units.Competitive base salary + bonuses + $750 / month managemen...[show_more][last_updated.last_updated_30]
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Community Director

Community Director

Gallery ResidentialCary, NC, US
[job_card.full_time]
The Community Director is responsible for maintaining the physical asset and maximizing the financial returns in accordance with the owner’s objectives. The Community Director complies with co...[show_more][last_updated.last_updated_30]
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Sr. Regulatory Affairs Associate

Sr. Regulatory Affairs Associate

GeneDxRaleigh, NC, US
[job_card.full_time]
GeneDx delivers personalized and actionable health insights to inform diagnosis, direct treatment, and improve drug discovery. The company is uniquely positioned to accelerate the use of genomic and...[show_more][last_updated.last_updated_variable_days]
Medical Affairs Program Manager

Medical Affairs Program Manager

ZOLL RespicardiaRaleigh, NC, United States
[job_card.full_time]
At ZOLL, we're passionate about improving patient outcomes and helping save lives.We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, softwar...[show_more][last_updated.last_updated_variable_days]
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Community Coordinator

Community Coordinator

Scale AIRaleigh, NC, United States
[job_card.full_time]
Join a global community of talented professionals to shape the future of AI.Earn up to $15 USD / hr and additional rewards based on quality of submission. Outlier is committed to improving the intelli...[show_more][last_updated.last_updated_variable_hours]
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Community Manager

Community Manager

Brookside PropertiesRaleigh, NC, US
[job_card.full_time]
Community Manager – The Lively Drayton Mills | Spartanburg, SC.This vibrant community blends classic elegance, bold style, and historic character for a one-of-a-kind living experience in &ldq...[show_more][last_updated.last_updated_variable_days]
Business Affairs Consultant

Business Affairs Consultant

VirtualVocationsRaleigh, North Carolina, United States
[job_card.full_time]
A company is looking for a Consultant, Business Affairs.Key Responsibilities Review, redline, and negotiate creator agreements on behalf of brand clients Advise, plan, and coordinate all aspects...[show_more][last_updated.last_updated_variable_days]
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Manager Public Affairs

Manager Public Affairs

Novant HealthRaleigh, NC, US
[job_card.full_time]
The Manager, Public Affairs plays a critical role in advancing Novant Health's mission to improve the health of communities, one person at a time. This role will help position Novant Health as a tru...[show_more][last_updated.last_updated_30]
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Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

TeleflexRaleigh, NC, US
[job_card.full_time]
Senior Regulatory Affairs Specialist.Regulatory Affairs Specialist (SRA) will develop US, EU, and Canada strategies, assessments, and submissions for complex projects across multiple business units...[show_more][last_updated.last_updated_30]
Government Affairs Intern

Government Affairs Intern

North Carolina Electric MembershipRaleigh, NC, United States
[job_card.full_time]
The Government Relations Department of the Raleigh-based North Carolina Association of Electric Cooperatives (NCAEC) has an opening for a Government Relations intern to assist in communications, le...[show_more][last_updated.last_updated_variable_days]
Director, Regulatory Affairs FSP

Director, Regulatory Affairs FSP

Thermo Fisher ScientificMorrisville, North Carolina, USA
[job_card.full_time]
We welcome applicants from all locations within the US.Must be legally authorized to work in the United States withoutsponsorship. Must be able to pass a comprehensive background check whichincludes...[show_more][last_updated.last_updated_variable_days]
Community Radiologist

Community Radiologist

Duke HealthRaleigh, NC, US
[job_card.full_time] +1
The Community Division of Duke University Department of Radiology.Duke Radiologys Community Division includes sixteen faculty and provides service throughout Wake County, North Carolina.The Communi...[show_more][last_updated.last_updated_30]
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Associate Regulatory Affairs Manager

Associate Regulatory Affairs Manager

Katalyst Healthcares & Life SciencesRaleigh, NC, US
[job_card.full_time]
Associate Regulatory Affairs Manager.Responsibilities : The Associate Regulatory Affairs Manager will support the development, review, and submission of regulatory documents for medical device and I...[show_more][last_updated.last_updated_30]
Political Affairs Internship

Political Affairs Internship

The Borgen ProjectRaleigh, NC, United States
[job_card.part_time] +1
Are you passionate about making a difference in the world? Look no further!.The Borgen Project is an international organization that works at the political level to improve living conditions for pe...[show_more][last_updated.last_updated_variable_days]
Environmental Affairs Manager

Environmental Affairs Manager

InsideHigherEdRaleigh, North Carolina, United States
[job_card.full_time] +1
Monday - Friday, 8 : 00 am - 5 : 00 pm; this position will be eligible for 1 day a week remote work environment after a training period and at the discretion of the supervisor and is subject to change ...[show_more][last_updated.last_updated_30]
Government Affairs Manager

Government Affairs Manager

JTIRaleigh, North Carolina, US,
[job_card.full_time]
We’re JTI, Japan Tobacco International and.We think that the possibilities are limitless when you’re free to choose.In fact, we’ve spent the last 20 years innovating, creating new and better produc...[show_more][last_updated.last_updated_30]
Environmental Affairs Manager

Environmental Affairs Manager

North Carolina State UniversityRaleigh, NC
[job_card.full_time] +1
Posting Information Posting Number PG194237EP Internal Recruitment No Working Title Environmental Affairs Manager Anticipated Hiring Range $100,000 - $110,000 Work Schedule Monday - Friday, 8 : 00 am...[show_more][last_updated.last_updated_30]
Sr. Manager, Regulatory Affairs

Sr. Manager, Regulatory Affairs

ChiesiCary, NC, United States
[job_card.30_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.job_description]

Chiesi USA

Based in Parma, Italy, Chiesi is an international research-focused biopharmaceutical group with 90 years' experience, operating in 31 countries. More than 7,000 employees across the group are united by a singular purpose : promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. Discover more here.

At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact.

Diversity, inclusion, and equal opportunity are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better.

Who we are looking for

Purpose

Develop regulatory strategies for North America region to meet Chiesi GRD Regulatory Affairsrelevant objectives, with full responsibility and no need of supervision by the line manager.

#LI-Remote

Main Responsibilities

  • In collaboration with consultants, partners and affiliates, plans, coordinate, and manage regulatory submissions to regional agencies throughout the life cycle of GRD products
  • Provide advice and guidance regarding regional regulatory requirements on assigned multidisciplinary project teams driving the development and

geographical expansion of GRDproducts

  • Contribute to the preparation and / or review of submissions to relevant markets to ensure high quality of the documentation
  • Communicate directly with regional regulatory authorities on behalf of Chiesi GRD unit to negotiate strategies and actions associated with regulatory
  • submissions

  • Critically review regulatory submission documents, periodic updates, overviews, summaries, etc., makes recommendations for improvement and
  • ensures adequacy for submission

  • To be delegated to the development ofprocesses and to the preparation of Standard Operating Documents for GRD Regulatory Affairs, where needed
  • Provide regulatory guidance to colleagues from other functional areas
  • Provide regulatory expertise in supportof due diligence assessments
  • Represent the Regulatory Departmentat the Core Team as global Regulatory Affairs member, where needed
  • With supervision of the line manager,coordinate the preparation of the needed documents for the scientific advice and lead discussions with
  • regional regulatory agencies

    Experience Required

  • 5-7 years of experience in corporate regulatory affairs roles with an in-depth knowledge of the drug development
  • Experience and knowledge in new MAAs and in the life cycle management of registered MAs
  • Ability to work independently in the preparation of high-quality submissions and submission documents
  • Strong attention to details and quality of the documentation and processes
  • Well-developed written and oral communication and listening skills
  • Well-developed time management skills and demonstrated ability to manage complex assignments
  • Experience in leadership and coaching is an asset
  • Well-developed analytical and problem-solving skills
  • Ability to work independently and as part of a team
  • Education

    Life Science Degree

    Compensation

    The annual base pay for this position ranges from $121,000 to $182,000. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. If hired, the employee will be in an "at-will position" and the Company reserves the right to modify base pay (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.

    What we offer

    No matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way.

    We provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support. Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive.

    Chiesi USA is an equal opportunity employer committed to hiring a diverse work force at all levels of our business. All qualified applicants receive consideration for employment without regard to race, national origin, age, sex, religion, disability, marital status, veteran status, or any other basis protected by local, state or federal law. This policy applies with regard to all aspects of one's employment, including hiring, transfer, promotion, compensation, eligibility for benefits and termination.