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4-6 years
6-10 years
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More than 15 years
Avatar of Tina Chou.
Avatar of Tina Chou.
Past
台灣研發中心-醫材法規人員(Medical Device Regulatory Affair Specialist at Taiwan RD center) @澳門商原妙醫學科技有限公司台灣分公司 (Honest Medical Equipment Macau Co., Ltd. Taiwan Branch)
2021 ~ 2023
Regulatory Affair Specialist
Within one month
sales chief to train the new trading specialists, assign and supervise their work. My second job is as an international trade specialist for importing European, USA, Japan, China & Nepal ophthalmic medical equipment as the authorized distributor. Except for international trade tasks, I was also responsible for product registration affairs. I had to apply for Quality System Documentation (QSD) and register a product importing license for foreign manufacturers for importing legally. This has allowed me to promote more practical experiences regarding registration affairs and I also participated in many regulatory courses in the past four years.
International Trade
ISO 13485:2016
Medical Device Quality Management System Regulations
Unemployed
Ready to interview
Full-time / Interested in working remotely
10-15 years
文藻外語學院
英國語文學系
Avatar of 陳毓茹.
Avatar of 陳毓茹.
Medical translator @Exfluency
2022 ~ Present
法規人員、臨床試驗專員
Within one month
Additionally, I played a pivotal role in the translation of technical documents, including Informed Consent Forms (ICF), Comprehensive Study Protocols (CSP), Clinical Study Reports (CSR), and various guidelines pertinent to clinical study projects. This multifaceted experience has equipped me with a comprehensive understanding of the intricacies of drug development, regulatory compliance, and effective communication within the pharmaceutical industry Working Experience Senior regulatory affairs specialist • CMIC Holdings Co., Ltd. FebPresent 1. Wrote a customized regulatory gap analysis report on oncological drugs for NDA submission 2. Support writing a BSE report (Oncology drug) and constructing the BSE
powerpoint
專案管理
outlook
Employed
Ready to interview
Full-time / Interested in working remotely
4-6 years
National Cheng Kung University
Pharmacology
Avatar of Anatoly Bogdanov.
Avatar of Anatoly Bogdanov.
self-learning @Student QA Engineer
2020 ~ Present
QA engineer
Within two months
User testing QA Engineer Product Business research Language Russian ・ Native English・Beginner Spanish・Beginner Professional Experience MarchPresent Learning JavaScript, TypeScript, Python, GIT, and QA Engineer. Troublehacking, Troubleshooting, QA Engineer, AWS, Cloud Google. CEO • NETFOX Ltd JanuaryMarch 2020 Registrar of domain names RF and RU, Data Center Operations Engineer, Regulatory Affairs Specialist, Data Center Innovation Manager, Web Hosting Customer Support, Affiliate Program Management, QA, Marketing Department, Troublehacking, Troubleshooting, The first use of a remote reset button in Russia for hosted servers in ATX cases. CEO • Internet agency RE: Play JanuaryDecember 2006 Web Hosting Customer Support, Affiliate Program Management
Studying
Full-time / Remote Only
More than 15 years
Avatar of Muhammad Iqbal.
Avatar of Muhammad Iqbal.
Pharmacist @PT. Kimia Farma Trading & Distribution Cabang Malang
2018 ~ 2023
Pharmacist
Within one year
PT. KIMIA FARMA APOTEK NovemberDesember 2017 I am in charge of helping give communication, information, and education to patients. Education Gadjah Mada University Master of Pharmacy ManagementAirlangga University Bachelor of Pharmacy and Pharmacist ProfessionHard Skills SAP Microsoft Excel Microsoft PowerPoint Google Things Soft Skills Management Skills Communication Skills Regulatory Affairs Teamwork Languages English — Intermediate Bahasa Indonesia - Fluent Projects Audit Good Drug Distribution Method (CDOB) This audit has been carried out in 2022 for three categories, namely Other Drugs, Cold Chain Products, and Narcotics from the Drug Supervisory Agency of the Republic of Indonesia (BPOM RI) Master of Management
Pharmaceutical Management
Managing Inventory
Regulatory Affairs
Full-time / Interested in working remotely
4-6 years
Universitas Gadjah Mada
Master Pharmacy Management
Avatar of A S M Sultan Mahmud Reza Khandaker.
Avatar of A S M Sultan Mahmud Reza Khandaker.
Sales Manager @Agro Link BD
2018 ~ 2023
Sales Manager
More than one year
kinds of 'on the job situation both mentally and physically. Proven track record in agricultural farm management Work Experience Sales Manager • Agro Link BD OctoberMarchMaking sales plan, sales budget preparation, monitoring sales officers' activities, provide training program, market channel linkage, achieve sales and collection target. 2. Oversee regulatory affairs, merchandising, product pricing and distinctive new product development to lead the market 3. Develop innovative marketing campaigns to increase engagement with target demographic and drive brand exposure. 4. Create effective strategies to target new markets after researching and analyzing competitor behavior. 5. Job
Potential
Ability To Work Independently
Develop Strategies
Full-time / Interested in working remotely
More than 15 years
University of Rajshahi
Marketing
Avatar of the user.
Avatar of the user.
Sell-Side Equity Research Analyst, TMT @Oscar Gruss Inc
2006 ~ 2010
Strategic Alliance Manager
More than one year
5G
Telecommunications Industry
Strategic Partnerships
Employed
Full-time / Interested in working remotely
10-15 years
Harvard Division of Continuing Education
Advanced Executive Communications Program
Avatar of Ruby Fang.
法規經理
Within six months
方韻茹 Ruby Fang 關於我 - 於化妝品/食品相關產業有9年以上經歷 - 專精於產品管理/產品法規/產品行銷 - 擅長公開授課演講 - 具良好組織性及專業邏輯思考能力,及良好跨部門合作及溝通能力 eMail: [email protected] 聯絡電話:居住地: 台北市 學歷 Kansas State University
Word
PowerPoint
Google Drive
Full-time / Interested in working remotely
6-10 years
Kansas State University
化妝品及食品產品管理與產品法規
Avatar of the user.
Associate Medical Officer
Within one year
Medical Devices
Regulatory Affairs
Full-time / Interested in working remotely
More than 15 years
Cochlear Foundational Curriculum
Mapping
Avatar of Katarzyna Reiss.
Avatar of Katarzyna Reiss.
Specialist within INTERNATIONAL DESK @UniCredit Group
2008 ~ 2008
Head of Overseas Marketing Office/Head of Regional Sales CIS/CEE
More than one year
overall oversees execution, adapt strategy and tactics to ensure successes in the market; deploy marketing support and train partner; proactively collaborating with the team of the different affiliates to drive product knowledge and grow the sales; participation at local events and conferences Management: Coordinate with other departments of Moleac: Logistics, Regulatory, Global Marketing, Medical Affairs, Moleac Singapore - Head of Global Marketing JanJan 2014, location SINGAPORE, BIOPOLIS Development and implementation of long term PR/marketing strategies Working closely with the CEO, Medical Directors, taking sole responsibility for the planning and delivery of all marketing and communications, monitoring press releases, delivering
Employed
Full-time / Interested in working remotely
10-15 years
Jagiellonian University
Postgraduate studies „Business in biotechnologii”,
Avatar of the user.
Avatar of the user.
Head of Legal @Center for Breakthrough Medicines
2020 ~ Present
More than one year
general corporate counsel
Life Science Industry
Biotechnology
Part-time / Interested in working remotely
More than 15 years
The University of Texas School of Law
Doctor of Law

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More than one year
Head of Legal
Center for Breakthrough Medicines
2020 ~ Present
Philadelphia, PA, USA
Professional Background
Current status
Job Search Progress
Professions
Legal Representative
Fields of Employment
Legal Department
Work experience
More than 15 years
Management
I've had experience in managing 15+ people
Skills
general corporate counsel
Life Science Industry
Biotechnology
Industry Knowledge
Pharmaceutical Law
biopharmaceuticals
Corporate Law
Licensing
Regulatory Compliance
Languages
English
Native or Bilingual
Job search preferences
Positions
Job types
Part-time
Locations
Remote
Interested in working remotely
Freelance
No
Educations
School
The University of Texas School of Law
Major
Doctor of Law
Print

Amiel Gross

Amiel Gross currently serves as Head of Legal at the Center for Breakthrough Medicines in Philadelphia, focusing on building and managing their legal functions. He is responsible for ensuring the business strategies and policies are aligned with all risks taken into consideration. Counselling executives and senior management, negotiating complex commercial transactions, facilitating strategic alliances, supporting a range of legal issues arising during highly-regulated biotechnology business operations - these topics highlight his work as an attorney who specialises in cell & gene therapy manufacturing.

This professional oversight responsibility and hands-on experience across an array of subjects. These subjects include licensing deals, master services agreements, procurement contracts, intellectual property, corporate affairs, sponsored R&D collaborations, FDA regulatory and compliance, litigation, labour and employment, cyber-security and privacy.

Amiel Gross studied International Law at the Queen Mary University of London. He holds a Bachelor of Arts Degree from Southwestern University and a Doctor of Law Degree from The University of Texas School of Law.

His skills include general corporate counsel, life science industry, biotechnology, industry knowledge, pharmaceutical law, bio pharmaceuticals, corporate law, licensing, regulatory compliance. He is also highly experienced at business transactions, commercial contracts, CDMO, CGT, cell and gene therapy.

  Philadelphia, PA, USA  https://www.crunchbase.com/person/amiel-gross      

Work Experience

Head of Legal  •  Center for Breakthrough Medicines

June 2020 - Present

Amiel Gross serves as Head of Legal at the Center for Breakthrough Medicines at Philadelphia since 2020. He focuses on building and managing the legal function of a rapidly growing biotechnology company in cell and gene therapy manufacturing.

General Counsel  •  Discovery Labs

January 2020 - May 2020

Managed internal legal matters for Discovery Labs, a life science real estate holding company, in connection with the spinoff of its core operating business, Center for Breakthrough Medicines, a biotech startup focused on outsourced end-to-end manufacturing of Cell & Gene Therapy drug products.

Senior Associate  •  Dentons

August 2009 - October 2014

Senior Associate at Dentons, a global law firm driven to provide you with the competitive edge in an increasingly complex and interconnected marketplace.

Associate  •  Orrick, Herrington & Sutcliffe LLP

January 2001 - November 2006

Associate at Orrick, Herrington & Sutcliffe LLP, a global law firm focused on serving the technology & innovation, energy & infrastructure and finance sectors.

Education

2004 - 2006

The University of Texas School of Law

Doctor of Law

2002 - 2005

Southwestern University School of Law

Law

1999 - 2002

Queen Mary University of London

International Law

Skills


  • general corporate counsel
  • Life Science Industry
  • Biotechnology
  • Industry Knowledge
  • Pharmaceutical Law
  • biopharmaceuticals
  • Corporate Law
  • Licensing
  • Regulatory Compliance

Languages


  • English — Native or Bilingual
Resume
Profile

Amiel Gross

Amiel Gross currently serves as Head of Legal at the Center for Breakthrough Medicines in Philadelphia, focusing on building and managing their legal functions. He is responsible for ensuring the business strategies and policies are aligned with all risks taken into consideration. Counselling executives and senior management, negotiating complex commercial transactions, facilitating strategic alliances, supporting a range of legal issues arising during highly-regulated biotechnology business operations - these topics highlight his work as an attorney who specialises in cell & gene therapy manufacturing.

This professional oversight responsibility and hands-on experience across an array of subjects. These subjects include licensing deals, master services agreements, procurement contracts, intellectual property, corporate affairs, sponsored R&D collaborations, FDA regulatory and compliance, litigation, labour and employment, cyber-security and privacy.

Amiel Gross studied International Law at the Queen Mary University of London. He holds a Bachelor of Arts Degree from Southwestern University and a Doctor of Law Degree from The University of Texas School of Law.

His skills include general corporate counsel, life science industry, biotechnology, industry knowledge, pharmaceutical law, bio pharmaceuticals, corporate law, licensing, regulatory compliance. He is also highly experienced at business transactions, commercial contracts, CDMO, CGT, cell and gene therapy.

  Philadelphia, PA, USA  https://www.crunchbase.com/person/amiel-gross      

Work Experience

Head of Legal  •  Center for Breakthrough Medicines

June 2020 - Present

Amiel Gross serves as Head of Legal at the Center for Breakthrough Medicines at Philadelphia since 2020. He focuses on building and managing the legal function of a rapidly growing biotechnology company in cell and gene therapy manufacturing.

General Counsel  •  Discovery Labs

January 2020 - May 2020

Managed internal legal matters for Discovery Labs, a life science real estate holding company, in connection with the spinoff of its core operating business, Center for Breakthrough Medicines, a biotech startup focused on outsourced end-to-end manufacturing of Cell & Gene Therapy drug products.

Senior Associate  •  Dentons

August 2009 - October 2014

Senior Associate at Dentons, a global law firm driven to provide you with the competitive edge in an increasingly complex and interconnected marketplace.

Associate  •  Orrick, Herrington & Sutcliffe LLP

January 2001 - November 2006

Associate at Orrick, Herrington & Sutcliffe LLP, a global law firm focused on serving the technology & innovation, energy & infrastructure and finance sectors.

Education

2004 - 2006

The University of Texas School of Law

Doctor of Law

2002 - 2005

Southwestern University School of Law

Law

1999 - 2002

Queen Mary University of London

International Law

Skills


  • general corporate counsel
  • Life Science Industry
  • Biotechnology
  • Industry Knowledge
  • Pharmaceutical Law
  • biopharmaceuticals
  • Corporate Law
  • Licensing
  • Regulatory Compliance

Languages


  • English — Native or Bilingual