Job summary
Job post source
This job is from a recruiting firm hiring for a separate company.
Job overview
The Associate Director of Regulatory Affairs role involves leading regulatory strategy and submissions for a biotech company, focusing on oncology and autoimmune diseases to ensure regulatory success and compliance.
Responsibilities and impact
The candidate will provide strategic regulatory leadership, oversee global regulatory submissions, drive regulatory strategy for clinical trials and approvals, liaise with regulatory authorities, and manage regulatory documentation and compliance.
Experience and skills
The position requires 8-10 years in pharma/biotech with 4-6 years in regulatory affairs, expertise in global regulatory submissions, knowledge of US and international regulations, and strong leadership and communication skills; large molecule experience is highly preferred.
Job location and travel
The job is located in the San Francisco Bay Area and requires candidates to reside there.
Company overview
Precision Point Staffing ™ is a staffing and recruiting company based in California, specifically serving areas such as San Francisco, Santa Ana, Irvine, Long Beach, Emeryville, North Hollywood, and Los Angeles. The company operates with a small team of 2-10 employees and specializes in managing full-cycle recruiting processes. They cater to various industries, including biotech and technology, offering both temporary and contract-to-permanent staffing solutions. Precision Point Staffing ™ is known for its tailored approach to talent acquisition, helping businesses find the right candidates for their specific needs.
How to land this job
Position your resume to highlight your expertise in Oncology and Autoimmune Diseases, emphasizing any large molecule experience to align with Precision Point Staffing's preferences.
Focus on showcasing your leadership in regulatory strategy, global submissions, and interactions with health authorities like FDA and EMA, as these are key responsibilities for the Associate Director role.
Apply through multiple channels including Precision Point Staffing's corporate website, LinkedIn job postings, and biotech industry job boards to maximize your application visibility.
Connect with professionals in Precision Point Staffing's regulatory affairs or biotech divisions on LinkedIn; start conversations by referencing recent regulatory trends or asking about their experience with global submissions to break the ice.
Optimize your resume for ATS by incorporating keywords such as ‘regulatory strategy,’ ‘global submissions,’ ‘FDA,’ ‘EMA,’ ‘clinical trial execution,’ and ‘large molecule’ to ensure your resume passes automated screenings.
Use Jennie Johnson's Power Apply feature to automate tailored applications across multiple platforms and identify relevant LinkedIn connections, allowing you to focus your time on networking and interview preparation.
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