Director Regulatory Affairs

2 months ago

Philadelphia, United States EPM Scientific Full time
Job DescriptionJob Description

Director of Regulatory Affairs Strategy

This position is with a rapidly growing pharmaceutical company known for its commitment to advancing transformative therapies. In this role you will have a unique opportunity to lead regulatory strategies for innovative pharmaceutical products, making a meaningful impact on patient health. You'll collaborate with cross-functional teams and engage directly with regulatory agencies, influencing critical decisions in drug development.

Key Responsibilities:

  • Oversee daily regulatory activities for projects involving compounds in development or on the market, including submission strategies and regulatory intelligence.
  • Collaborate with Project Teams to develop regulatory and product strategies, including drafting labeling and NDA package inserts.
  • Work with various departments to formulate and execute effective Regulatory Strategies, assessing and communicating regulatory risks and opportunities.
  • Manage submissions and maintenance of INDs, NDAs, MAAs, and related documents.
  • Support due diligence activities for potential product acquisitions or partnerships.
  • Serve as the primary regulatory contact with agencies, including the FDA, and represent the regulatory function in key meetings.
  • Monitor the regulatory landscape and communicate updates to stakeholders.
  • Advise on regulatory requirements to support business strategies, providing expert guidance on scientific and medical issues.

Qualifications:

  • Bachelor's degree in life sciences or related field; advanced degree preferred.
  • Minimum 10 years of experience in pharmaceutical regulatory drug development.
  • Proven track record in new chemical entity and line extension filings.
  • Experience interacting with global health authorities and conducting due diligence.
  • Strong knowledge of global pharmaceutical regulations and excellent communication skills.

Company DescriptionA top 10 pharmaceutical company with an immense amount of growth after releasing their at home COVID diagnostic tests is looking to bring on 200+ Quality Individuals through a massive hiring campaign. In their search for Quality Specialists, the organization is looking for individuals who will be responsible for reviewing and actioning customer complaints, as well as investigation into said complaints.
Job Responsibilities:
•\tConducting Post Market Activities and Post Market Surveillance
•\tManaging Customer and Product Complaint Investigation programs
Education and Experience:
•\t1 YR. of experience in a technical role in the medical device/pharma/biotech industry
•\tBachelor's degree
•\tComputer proficiencyCompany DescriptionA top 10 pharmaceutical company with an immense amount of growth after releasing their at home COVID diagnostic tests is looking to bring on 200+ Quality Individuals through a massive hiring campaign. In their search for Quality Specialists, the organization is looking for individuals who will be responsible for reviewing and actioning customer complaints, as well as investigation into said complaints.\r
Job Responsibilities:\r
•\tConducting Post Market Activities and Post Market Surveillance\r
•\tManaging Customer and Product Complaint Investigation programs\r
Education and Experience:\r
•\t1 YR. of experience in a technical role in the medical device/pharma/biotech industry\r
•\tBachelor's degree\r
•\tComputer proficiency

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