Polaris Pharmaceuticals Inc.

Associate Director/ Director Regulatory Affairs CMC

VACAVILLE, CAPosted 30+ days ago

Job summary

  • Job post source

    This job is directly from Polaris Pharmaceuticals Inc.

  • Job overview

    The Associate Director/Director of Regulatory Affairs CMC will provide strategic input and oversight for CMC-related regulatory compliance, collaborating with teams to drive regulatory strategies and submissions.

  • Responsibilities and impact

    Daily responsibilities include developing global CMC regulatory strategies, authoring regulatory documents, leading interactions with health authorities, and ensuring compliance with regulatory requirements.

  • Experience and skills

    Candidates should have a Bachelor's degree in a scientific field, 6-10 years in biotechnology, with 4-5 years in Regulatory Affairs CMC, and knowledge of global regulatory submissions and cGMP.

  • Work environment and culture

    The company values respect, passion, teamwork, integrity, honesty, commitment, and collaboration.

  • Company information

    Polaris Pharmaceuticals Inc. is focused on regulatory compliance in biotechnology, emphasizing product development and registration.

  • Job location and travel

    The position is located in Vacaville.

Company overview

Polaris Pharmaceuticals Inc. is a biopharmaceutical company focused on developing and commercializing innovative cancer therapies. They generate revenue through the research, development, and sale of proprietary drugs designed to target and treat various forms of cancer. Founded in 2006, the company has made significant strides in oncology, with several products in different stages of clinical trials. Polaris is known for its commitment to advancing cancer treatment and improving patient outcomes through cutting-edge science and technology.

How to land this job

  • Tailor your resume to highlight your experience in CMC regulatory affairs, focusing on your ability to develop and execute global regulatory strategies, as this is a key responsibility for the role at Polaris Pharmaceuticals Inc.

  • Emphasize your skills in authoring and reviewing regulatory documents, particularly for INDs, BLAs, and other CMC-related submissions, as these are crucial for compliance and oversight.

  • Apply through multiple channels, including the Polaris Pharmaceuticals corporate site and LinkedIn, to enhance your visibility for the Associate Director/Director position.

  • Connect with professionals in the Regulatory Affairs division at Polaris Pharmaceuticals on LinkedIn to inquire about the position; consider ice breakers like asking about their recent projects or expressing your admiration for their compliance initiatives.

  • Optimize your resume for ATS systems by incorporating relevant keywords from the job description, such as 'CMC regulatory strategies,' 'IND submissions,' and 'cGMP,' to ensure your application passes initial screenings.

  • Utilizing Jennie Johnson's Power Apply feature can streamline your application process by tailoring your resume, identifying the best channels to apply through, and helping you connect with the right people, allowing you to focus on other important aspects of your job search.

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