Tony Calandra

Tony Calandra Email and Phone Number

Senior Consultant, Regulatory Strategy at PHARMALEX US @
Tony Calandra's Location
Burlingame, California, United States, United States
Tony Calandra's Contact Details

Tony Calandra work email

Tony Calandra personal email

Tony Calandra phone numbers

About Tony Calandra

21+ years experience in regulatory affairs in multiple therapeutic areasSpecialties: Recombinant protein products (biotechnology)CMCInternational regulatory FDA negotiations

Tony Calandra's Current Company Details
PHARMALEX US

Pharmalex Us

Senior Consultant, Regulatory Strategy at PHARMALEX US
Tony Calandra Work Experience Details
  • Pharmalex Us
    Senior Consultant, Regulatory Strategy
    Pharmalex Us 2015 - Present
    Experienced regulatory professional who can provide in-depth advice to clients to develop sound regulatory strategies for small molecule and biologic candidates across a variety of therapeutic areas.
  • Genentech
    Regulatory Principal
    Genentech Aug 2011 - Oct 2014
    South San Francisco, California, Us
    View
  • Biogen Idec Pharmaceuticals
    Director Regulatory Intelligence
    Biogen Idec Pharmaceuticals Nov 2009 - Jul 2011
    Cambridge, Ma, Us
    Leading the department's global efforts to find changes in the regulatory environment, interpret these changes, and implement necessary changes in the organization's processes and work practices
    View
  • Biogen Idec Pharmaceuticals
    Director Development Regulatory Affairs
    Biogen Idec Pharmaceuticals Mar 2008 - Nov 2009
    Cambridge, Ma, Us
    Provide regulatory strategy on preclinical clinical development issues. Serve as liason between the company and FDA
    View
  • Biogen Idec Pharmaceuticals
    Director Cmc Regulatory Affairs
    Biogen Idec Pharmaceuticals Jun 2007 - Mar 2008
    Cambridge, Ma, Us
    View
  • Bristol-Myers Squibb
    Director, Global Regulatory Strategy
    Bristol-Myers Squibb Jan 2004 - Jun 2007
    Lawrence Township, Nj, Us
    Responsible for development and successful execution of regulatory strategy for BMS' initial entry into the world of biologic therapeutics.Filed and gained approval for Orencia (a novel, recombinant protein therapeutic for the treatment of rheumatoid arthritis) in US and EU. Also filed and gained approval for subsequent efficacy and comparability supplements.
    View
  • Amgen Inc.
    Associate Director Reg Affairs
    Amgen Inc. 1992 - 2004

Tony Calandra Skills

Biotechnology Clinical Development Cro Cmc Immunology Fda Regulatory Affairs Biopharmaceuticals Pharmaceutical Industry Drug Development Ind Regulations Biologics Regulatory Submissions Gcp Oncology Protein Chemistry Medical Affairs Clinical Trials Technology Transfer Drug Discovery Therapeutic Areas U.s. Food And Drug Administration

Tony Calandra Education Details

  • University Of Tennessee, Knoxville
    University Of Tennessee, Knoxville
    Emphasis On Biochemistry
  • University Of Tennessee, Knoxville
    University Of Tennessee, Knoxville
    Emphasis In Genetics
  • Union College
    Union College
    Biology

Frequently Asked Questions about Tony Calandra

What company does Tony Calandra work for?

Tony Calandra works for Pharmalex Us

What is Tony Calandra's role at the current company?

Tony Calandra's current role is Senior Consultant, Regulatory Strategy at PHARMALEX US.

What is Tony Calandra's email address?

Tony Calandra's email address is to****@****ail.com

What is Tony Calandra's direct phone number?

Tony Calandra's direct phone number is (617)-679*****

What schools did Tony Calandra attend?

Tony Calandra attended University Of Tennessee, Knoxville, University Of Tennessee, Knoxville, Union College.

What skills is Tony Calandra known for?

Tony Calandra has skills like Biotechnology, Clinical Development, Cro, Cmc, Immunology, Fda, Regulatory Affairs, Biopharmaceuticals, Pharmaceutical Industry, Drug Development, Ind, Regulations.

Free Chrome Extension

Find emails, phones & company data instantly

Find verified emails from LinkedIn profiles
Get direct phone numbers & mobile contacts
Access company data & employee information
Works directly on LinkedIn - no copy/paste needed
Get Chrome Extension - Free

Aero Online

Your AI prospecting assistant

Download 750 million emails and 100 million phone numbers

Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.