Alexander Nikas

Alexander Nikas Email and Phone Number

VP Legal and Gov Affairs, Chief Regulatory and Commercial Counsel, Head of Regulatory Affairs @ Par Health
Philadelphia, PA, US
Alexander Nikas's Location
Malvern, Pennsylvania, United States, United States
Alexander Nikas's Contact Details
About Alexander Nikas

Pharmaceutical compliance, R&D, regulatory and labeling attorneySpecialties: pharmaceutical regulatory compliance, clinical trials and promotional review

Alexander Nikas's Current Company Details
Par Health

Par Health

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VP Legal and Gov Affairs, Chief Regulatory and Commercial Counsel, Head of Regulatory Affairs
Philadelphia, PA, US
Alexander Nikas Work Experience Details
  • Par Health
    Vp Legal And Gov Affairs, Chief Regulatory And Commercial Counsel, Head Of Regulatory Affairs
    Par Health
    Philadelphia, Pa, Us
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  • Endo
    Vice President & Asst General Counsel Global Commercial Ops And R&D
    Endo Jun 2022 - Present
    Malvern, Pa, Us
    Leads a team of legal professionals to provide commercial, regulatory, R&D, Government Affairs, compliance counsel and support
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  • Teva Pharmaceuticals
    Associate General Counsel - Clinical And Labeling
    Teva Pharmaceuticals Apr 2019 - Jun 2022
    Tel-Aviv, Il
    Principal legal support for all product labeling activities including review and approval of prescribing information, packaging and promotional labeling and advertising. Leads a team of attorneys and paralegals to provide legal support to Research & Development, by (i) counseling on issues such as informed consent, study design, and FDA interactions, (ii) negotiating, drafting, and counseling on agreements and other documents relating to the research and development of pharmaceutical products, including clinical trial agreements, and (iii) collaborating and interfacing with other internal groups (such as Compliance, Regulatory Affairs, etc.) to ensure compliance with applicable laws, regulations, and policies.
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  • Teva Pharmaceuticals
    Sr. Director - Executive Counsel
    Teva Pharmaceuticals Nov 2007 - Apr 2019
    Tel-Aviv, Il
    In-house pharmaceutical regulatory compliance attorney responsible for counseling Migraine, Respiratory, Biologics (including proposed biosimilars), Oncology and Pain (including opioids) therapeutic areas, including marketing and sales, healthcare regulatory compliance, promotional review, labeling, contracting, product liability, and counseling on all aspects of products from clinical development through marketing. Prior experience with addiction, womens health and psychiatry therapeutic areas. Experience includes counseling clinical research including negotiating international clinical trial agreements, counseling on privacy and reimbursement issues, pharmacovigilance, environmental health and REMS.
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  • Cephalon
    Regulatory Counsel
    Cephalon Nov 2007 - Oct 2011
    Us
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  • Pepper Hamilton Llp
    Associate Attorney
    Pepper Hamilton Llp Aug 2005 - Nov 2007
    United States, Us
    Defense attorney for pharmaceutical and medical device manufacturers: product liability litigation experience includes: evaluating medical and scientific experts, reports and testimony; corporate witness preparation; drafting motions and briefs; negotiations with FDA and Department of Justice. Focus on regulatory aspects of mass tort litigation. Consulting attorney for life sciences corporate group: performed due diligence review of biotechnology company clinical development program of cancer therapies.
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  • Merck
    Epidemiologist
    Merck Oct 1997 - Sep 2005
    Rahway, New Jersey, Us
    Responsible for writing epidemiologic reports, questionnaires and outcome measures, and designing, coordinating, monitoring and analyzing epidemiologic studies to support Merck vaccine and infectious disease products. Job experience includes drafting, negotiating and implementing contracts and legal documents for research studies, consulting on product labeling, and evaluating and avoiding both scientific and legal research liabilities.
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  • Fda
    Intern
    Fda Feb 1997 - Sep 1997
    Silver Spring, Md, Us
    Masters thesis project; Designed and implemented surveillance study of adverse events associated with implantable devices. Researched post-marketing surveillance techniques and medical device AE reporting.
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Alexander Nikas Skills

Pharmaceutical Industry Clinical Trials Biotechnology Clinical Development Lifesciences Regulatory Affairs Clinical Research Regulatory Requirements Healthcare Vaccines Regulatory Submissions Licensing Managed Care Pharmaceutical Law Corporate Law Patent Prosecution Litigation

Alexander Nikas Education Details

  • Dartmouth College
    Dartmouth College
    Biology
  • Temple University - James E. Beasley School Of Law
    Temple University - James E. Beasley School Of Law
    Law
  • The George Washington University- Milken Institute School Of Public Health
    The George Washington University- Milken Institute School Of Public Health
    Public Health

Frequently Asked Questions about Alexander Nikas

What company does Alexander Nikas work for?

Alexander Nikas works for Par Health

What is Alexander Nikas's role at the current company?

Alexander Nikas's current role is VP Legal and Gov Affairs, Chief Regulatory and Commercial Counsel, Head of Regulatory Affairs.

What is Alexander Nikas's email address?

Alexander Nikas's email address is ni****@****law.com

What schools did Alexander Nikas attend?

Alexander Nikas attended Dartmouth College, Temple University - James E. Beasley School Of Law, The George Washington University- Milken Institute School Of Public Health.

What skills is Alexander Nikas known for?

Alexander Nikas has skills like Pharmaceutical Industry, Clinical Trials, Biotechnology, Clinical Development, Lifesciences, Regulatory Affairs, Clinical Research, Regulatory Requirements, Healthcare, Vaccines, Regulatory Submissions, Licensing.

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