Senior Associate Regulatory Affairs

1 week ago

Redwood City, CA, United States Planet Pharma Full time
Job Description

Senior Associate Regulatory Affairs

The Senior Associate Regulatory Affairs will support Senior Regulatory Affairs management in day-to-day operational aspects of the department and will support interactions with global regulatory authorities.

Specifically, you will be responsible for:
  • Represent Regulatory Affairs on study teams and closely collaborate with multidisciplinary teams and Clinical Research Organizations (CROs) to identify submission requirements, coordinate the content and development process (planning, creation, review, and approval) of selected regulatory documentation for inclusion in submissions to global health authorities.
  • Compile regulatory submissions that meet ICH or FDA requirements, other local or regional regulatory requirements, as applicable, and company policies and procedures.
  • Prepare and manage routine submissions and related activities. Define timelines to ensure timely delivery of high-quality, compliant, accurate and complete regulatory submissions.
  • Assist in the development and implementation of SOPs and systems to track and manage product-associated events.
  • Investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context to assist in assessment of regulatory implications for development and approval. Assist in the development of regulatory strategy and update strategy based upon regulatory changes.
  • Stay abreast of changes in the regulatory environment and guidelines (e.g., FDA, ICH) in areas relevant to company projects.
  • Work with manager on obtaining and developing required regulatory skills and knowledge.
Required Skills, Experience and Education:
  • Bachelor's degree in a relevant field.
  • Two or more years prior experience in a Regulatory Affairs department at a drug or biologics company.
  • Familiarity with regulatory requirements for development of drug or biological products, including FDA regulations and guidance, and ICH guidelines.
  • Technical expertise with Windows, MS Office (Outlook, Word, Excel), Adobe Acrobat software systems, and experience working in electronic document management systems.
Additional Skills:
  • Experience in global Clinical trials.
  • Experience in oncology drug development.
  • Experience with supporting the preparation and submission of large complex regulatory submissions.


Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.

Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.

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