Amneal Pharmaceuticals LLC (J0P)

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Regulatory Affairs Specialist (Biotech)



Description:

The Regulatory Affairs Specialist assists in the preparation, review and submission of high quality, regulatory submissions such to the Food and Drug Administration (FDA) and other Health Authorities, as required, within company timelines and in accordance with regulatory guidelines and applicable federal laws.

Essential Functions:

  • The Regulatory Affairs Specialist, assists in the management of regulatory submissions to (FDA) and other Health Authorities, as required, within company timelines and in accordance with regulatory guidelines and applicable federal laws. This may include but it is not limited to New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Investigational New Drug Application (IND), Biologics License Applications (BLA), Marketing Authorizations (MA), Post-Approval Supplements, Annual Reports (AR), Periodic Adverse Drug Experience Report (PADER), Controlled Correspondences (CC) and End-User Letters (EUL).
  • Assists in tracking and managing the status of submissions under review with FDA as per the Generic Drug User Fee Amendments (GDUFA) requirements. Ensures that internal tracking systems are always up to date. This includes relevant databases in the Amneal Application Suite and well as internal trackers and PowerPoint presentations for management meetings.
  • Assists in tracking the committed timeliness and follows up with the internal departments for required documents. Coordinates with external vendors, contractors and consultants for project support activities. This may include but is not limited to: US Agent Letters, and other certifications/statements required by FDA and other Health Authorities.
  • Assists in organizing meetings with FDA or other Health Authorities, including submitting the meeting requests, setting up internal preparation meetings, assist meeting leads in preparing presentations and talking points, and type-up meeting minutes.
  • Organizes and maintains submission components associated with electronic submissions. This may include scanning, converting to PDF, bookmarking, hyper linking, electronic processing and uploading in e-CTD Xpress in coordination with Regulatory Operations Department.


Additional Responsibilities:

  • Gains knowledge in the use of e-CTD structures for submissions.
  • Works with colleagues in resolving regulatory issues and/or problems.
  • Archives and maintains all submissions in a systematic way.
  • Performs administrative functions as directed by management to support projects and to ensure the smooth operation of the department.
  • Maintains current knowledge of regulations and other issues that affect products and industry.
  • Ensures that information from FDA and other Health Authorities is disseminated internally as required.
 

Education:

  • Bachelors Degree (BA/BS) Scientific or technical discipline - Required
  • Master Degree (MS/MA) - Preferred

Experience:

  • 2 years or more in Regulatory affairs or a related function within the pharmaceutical, biotechnology, or life sciences industry

Skills:

  • Time management, organization and planning skills, multi-tasking and prioritization skills in a fast-paced environment are required. - Proficient
  • Ability to maintain a high level of accuracy and attention to detail, while meeting deadlines for assigned projects. - Advanced
  • Excellent written and verbal communication skills and interpersonal skills. - Advanced
  • Ability to communicate effectively and collaboratively as part of a team in a respectful manner. - Proficient
  • Ability to interface with professionals domestically and abroad. - Intermediate
  • Ability to work independently, self-starter. - Proficient
  • Good problem-solving skills and analytical ability. - Proficient
  • Strong computer skills in order to learn new programs as quickly as possible. Experience in MS Word, Excel, Outlook and Adobe Acrobat is a must. - Advanced

Specialized Knowledge:

  • Proofreading abilities.
  • Working knowledge and experience with 21 CFR, US FDA guidance, ICH guidelines

The base salary for this position ranges from $80,000 to $95,000 annually. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, with this position within the first 12 months. Amneal ranges reflect the Company's good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life's many other commitments and opportunities.

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