With work experience over 16 years, this person is currently working at Pharmalucence, Inc as a Director Regulatory Affairs. Anila received his education from 1995 to 1997 at the Mediterranean Agronomic Institute of Chania, Greece. This professional has gained certifications in Rac This professional is located in Malden, Massachusetts. To contact with Anila, you can look for their phone number or e-mail address or receive exhaustive info by requesting access to this professional's additional details on this website.
Name variants:
Anila Mico
Last updated Jun 25, 2024
Contact Information
Last Update
Jul 13, 2022
Email
an**@yahoo.com, am**@raps.org
Location
Malden, MA
Company
Workplace
Director Regulatory Affairs
Billerica, MA
Industry
Pharmaceuticals, Whol Medical/Hospital Equipment Mfg Pharmaceutical Preparations, Mfg Pharmaceutical Preparations, Commercial Physical Research, Commercial Physical Research, Nsk, Nonclassifiable Establishments, Druggists' Goods Merchant Whols
Colleagues
Work History
Director Regulatory Affairs
NDA/ANDA submissions for radiopharmaceutical products, cGMP compliance and FDA inspections, post-marketing drug adverse event reporting, establishment and drug listing, RA department lead.
from Feb 2011
Associate Director, Global Regulatory Fertility & Endocrinology
Define the GRA strategy and prepare regulatory submissions for drug and drug device combination products.
Jul 2010 — Feb 2011
Senior Regulatory Affairs Specialist
• Prepare NDA, IND and ANDA in CTD and non- CTD format.
• Prepare CBE, CMC, DMF, ADE, DDMAC, NDA & ANDA AR, IND Amendments, facility registrations, drug listing, product labels, FDA Me...
Feb 2006 — Jul 2010
Regulatory Affairs Specialist
• Prepare ANDA, ANADA, CMC, DMF, CBE, ADE and annual product review and trending reports.
• Review of all CMC and clinical submission documents.
• Prepare product labels and site master file...
May 2004 — Dec 2005
Chemist
• Performed drug chemical analysis on finished products and raw materials using wet chemistry, HPLC, UV-VIS, AA, TLC, IR, dissolution apparatus, KF titrino, viscosimeters, etc.
• Performed ...
Mar 2003 — May 2004
Regulatory Affairs Specialist
• Prepared Drug Applications for Marketing Licenses. The company produced a range of about 400 generic Rx drug products, and exported in Eastern Europe, North Africa, Asia.
• Prepared chemi...
Jul 2000 — Jul 2001
Chemist
• Performed drug chemical analyses and review of the CMC section of Drug Applications for Marketing Licenses submitted by Albanian or international pharmaceutical companies.
• Performed dru...
Jan 1992 — Jul 2000
Education
1986 — 1991
Occupations
Executive
Vice President
Director
Deputy Director
Chief Executive
Operations Manager
Deputy Manager
Skills
Fda
Gmp
Regulatory Submissions
Regulatory Affairs
Validation
Sop
Pharmaceutical Industry
Quality System
Ind
Analytical Chemistry
Capa
21 Cfr Part 11
Clinical Trials
Hplc
Gxp
Drug Development
Biopharmaceuticals
Glp
Anda
V&V
Cmc
Regulatory Requirements
Standard Operating Procedure
U.s. Food and Drug Administration
Uv/Vis
Change Control
Ectd
Technology Transfer
Dissolution
Lims
Nda
Corrective and Preventive Action
Good Laboratory Practice
High Performance Liquid Chromatography
Uv/Vis Spectroscopy
Abbreviated New Drug Application
Verification and Validation
New Drug Application
Laboratory Information Management System
FAQs about Anila Mico
What's the main profession of Anila Mico?
The expert is a Vice President, Regulatory Affairs North America.
What are the main profession of Anila?
These person's professions are Executive and Vice President
Where does Anila Mico live?
Malden, Massachusetts is the place where Anila Mico lives
What is Anila Mico's email?
Anila Mico's email is an**@yahoo.com and am**@raps.org.
How many companies did Anila Mico work at?
The professional worked at seven jobs.
Where has Anila Mico studied?
Anila studied at the Mediterranean Agronomic Institute of Chania, Greece from 1995 to 1997.
Are there any professional certifications, that Anila Mico has?
The professional received the following certifications: Rac.
What is the industry that Anila Mico is connected to?
Anila Mico works in Pharmaceuticals industry.