- Lead development and implementation of Clinical Trial Application (CTA) strategies in line with defined goals
- Lead day-to-day execution of clinical trials, following applicable Standard Operating Procedures (SOPs) and regulatory requirements
- Prepare CTA and coordinate development of response to Health Authorities questions, working in close collaboration with cross-functional colleagues
- Act as primary regulatory contact point with internal and external stakeholders for assigned clinical trials and represent regulatory function in the respective study teams
- Provide input on documents submitted to the Health Authorities, in accordance with relevant CTA guidelines and applicable commitments
- Manage other CTA activities, including, but not limited to, Trial Master File (TMF) maintenance and Quality Control
- Accountable for maintenance of compliant regulatory information and applicable tracker for their respective product(s)
- Participate in the development of processes and procedures relevant to the regulatory submissions
- Share information to project team colleagues on regulatory requirements
- May lead more complex clinical trial regulatory submissions, impacting different studies and therapeutic areas
- Contribute to development of global regulatory strategies through interaction with regulatory colleagues
- Preparing regulatory submissions and acting as contact with regulatory agencies
- Participating in the development of processes and procedures relevant to the submissions
- Working collaboratively with the product team to ensure that quality and regulatory standards are considered throughout the product development life cycle
- Sharing information on regulatory requirements
- Continually monitoring the regulatory environment to maintain expertise in regulatory principles, new issues, competitive products, and implications
- Performing regulatory intelligence related to clinical trials
- Supporting regulatory leads as regulatory representative within cross-functional teams to provide expert interpretation of relevant laws, regulations, and company policies
- Proposing improvement of the submissions process
- Pharmacist or equivalent education in a life science (biology, chemistry, etc.)
- 5+ year experience in Regulatory Affairs within the pharmaceutical industry
- Good English oral and written communication skills
- Working knowledge of Agency regulations and industry standards pertaining to regulatory
- Experience on clinical trial application submissions, including with EU Clinical Trial Regulation
- Understanding of context and content of regulatory submissions and drug development process
- The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
- Experience liaising with regulatory agencies
- Good communication skills and collaborative mindset
- Ability to support projects to completion/ experience working in project teams
- Ability to work independently in a flexible environment to meet all regulatory requirements and business requirements
- Good project management and organizational skills
- Some travels might be required
- Experience with gene therapy programs and orphan developments is a plus
- Experience with regulatory inspections is a plus
-
Regulatory Affairs
5 dni temu
People Sp. z o.o. Warsaw, PolskaDla Naszego Klienta – międzynarodowej firmy z branży farmaceutycznej poszukujemy osoby na stanowisko: · Regulatory Affairs / Pharmacovigilance Specialist · Lokalizacja: Warszawa Śródmieście (praca hybrydowa) · Zakres obowiązków: · Działania związane z utrzymaniem pozwoleń na dopu ...
-
Regulatory Affairs Manager
3 godziny temu
Michael Page Warsaw, PolskaManaging all regulatory processes for our brand: Rx, OTC, food supplements, incl. management of product registration documents (procedures NP, MRP, DCP) · coordination of all regulatory submissions and commitments, to obtain the approval decisions · Close cooperation with medical ...
-
Regulatory Affairs Associate
6 dni temu
Zoetis Warsaw, Polska W pełnym wymiarze godzinRegulatory Affairs Associate - Contract for 1 year · Position purpose: · The Regulatory Affairs Associate will be part of a small team in Poland acting as a bridge between our Research and Development (R&D) and International Operations (Commercial) divisions, ensuring that re ...
-
Senior Regulatory Specialist, EMEA Regulatory Affairs
7 godzin temu
Boston Scientific Warsaw, PolskaAdditional Locations: · Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance · At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some ...
-
Regulatory Affairs Manager CEE
3 dni temu
Coty Warszawa, PolskaTHE ROLE · In this role you will be responsible for: · Monitoring EU and national Regulatory environment related to consumer goods, sustainability, and chemical regulations. · Connecting with key Trade associations and establish local consultants' network that, together with the ...
-
Regulatory Affairs Project Director
6 dni temu
AstraZeneca Warsaw, Polska W pełnym wymiarze godzinThe Regulatory Affairs Project Director (RAPD) is an experienced regulatory specialist with strong project management capabilities who takes on critical leadership roles for particularly complex and high priority global regulatory projects and / or major submissions. Typical capa ...
-
Ergomed Warsaw, Polska W pełnym wymiarze godzinJob Description · We are looking for someone who can speak German · Provides Study Start-Up Specialist activities in support of assigned projects including regulatory submissions, informed consent review, site contract/budget negotiation, essential document collection and review ...
-
Ergomed Warsaw, Polska W pełnym wymiarze godzinJob Description · We are looking for someone who can speak German · Provides Study Start-Up Specialist activities in support of assigned projects including regulatory submissions, informed consent review, site contract/budget negotiation, essential document collection and revi ...
-
Colgate-Palmolive Company Błonie, PolskaNo Relocation Assistance Offered · # Warsaw, Mazovia, Poland · Who We Are · Colgate-Palmolive Company is a caring, innovative growth company that is reimagining a healthier future for all people, their pets and our planet. Focused on Oral Care, Personal Care, Home Care and Pet Nu ...
-
Haleon Warsaw, Polska W pełnym wymiarze godzinHello. · We're Haleon. · A new world-leading consumer health company. · Shaped by all who join us. · Together, we're improving everyday health for billions of people. · By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil ...
-
Medical Affairs Manager Poland
3 dni temu
Galderma Warsaw, Polska W pełnym wymiarze godzinWith a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans th ...
-
Medical Affairs Manager Poland
3 dni temu
Galderma Warsaw, Polska W pełnym wymiarze godzinDescription · Key Responsibilities · Provide expert medical advice and education to internal and external stakeholders on Galderma's products, clinical trials, and new developments. · Develop and implement local medical affairs plans aligned with global strategy. · Lead the tr ...
-
Regulatory Specialist, Product Variations
11 godzin temu
GSK Warsaw, Polska W pełnym wymiarze godzinGlobal Regulatory Centres in GSK are regulatory affairs functions which bring together the operation and execution aspects for key regulatory deliverables such as new chemical entity and product expansion dossiers, labelling outputs, licence maintenance and lifecycle management d ...
-
Haleon Warsaw, Polska W pełnym wymiarze godzinHello. We're Haleon.A new world-leading consumer health company. Shaped by all who join us. Together, we're improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil, Voltaren, ...
-
Regulatory Submission Specialist
6 dni temu
Publicis Le Pont Warsaw, Polska W pełnym wymiarze godzinJob Description · As a Regulatory Submission Specialist, you will be responsible for researching medical documents, finding the correct references for pharmaceutical marketing assets, submitting this content into Veeva Vault platform and maintaining internal processes and projec ...
-
Cee Regulatory Innovation Manager
4 godziny temu
Haleon Warsaw, Polska W pełnym wymiarze godzinHello. · We're Haleon. · A new world-leading consumer health company. · Shaped by all who join us. · Together, we're improving everyday health for billions of people. · By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil ...
-
Real World Evidence Manager
2 dni temu
AstraZeneca Warsaw, Polska W pełnym wymiarze godzinAt AstraZeneca, we are united by a common purpose: to push the boundaries of science to deliver life-changing medicines. Every day, we make a difference by delivering potentially life-changing medicines to millions of people worldwide. Our purpose is results-oriented and so is ou ...
-
Finance Senior Manager
3 godziny temu
Citi Warsaw, Polska W pełnym wymiarze godzinPost location : Warsaw, Prosta 36 · About the Role: · The will be responsible for supporting key aspects of Prudential Capital Regulatory Policy, with particular emphasis on Recovery & Resolution and associated regulations. The Incumbent will be reporting to International Regula ...
-
Senior Global Development Scientist Director
6 dni temu
AstraZeneca Warsaw, Polska W pełnym wymiarze godzinJob Title: Senior Global Development Scientist Director · Locations: In Office in one of these locations - Boston Seaport, Warsaw PO, Barcelona SP or Mississauga CA · As a Senior Global Development Scientist Director (SGDSD) you will independently provide scientific and clini ...
-
Finance Senior Manager
11 godzin temu
11101 Citibank Europe plc Poland Warsaw, Polska W pełnym wymiarze godzinPost location : Warsaw, Prosta 36 · About the Role: · The will be responsible for supporting key aspects of Prudential Capital Regulatory Policy, with particular emphasis on Recovery & Resolution and associated regulations. The Incumbent will be reporting to International Regula ...
Manager, Clinical Trial, Global Regulatory Affairs - Warsaw, Polska - AstraZeneca
Opis
Alexion has over 3,000 talented colleagues dedicated to serving people living with rare diseases in more than 50 countries around the world. Our global headquarters are based in Boston, Massachusetts and our EMEA headquarters are in Zürich, Switzerland and Barcelona, Spain. We also have a Research Center of Excellence in New Haven, Connecticut, global supply chain and operations headquarters in Ireland, as well as local and regional operations in countries around the world, including Poland.
Alexion, AstraZeneca Rare Disease , is the group within AstraZeneca focused on rare diseases, created following the 2021 acquisition of Alexion Pharmaceuticals, Inc
This is what you will do:
You will be responsible for:
You will need to have:
We would prefer for you to have:
Date Posted
25-mar-2024Closing Date
30-kwi-2024Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact . Alexion participates in E-Verify.
