Pharmaceutical & Medical Device Regulatory Affairs Director
Collidion, Inc. and it’s subsidiaries, Plex Pharmaceuticals & Avenlogics, Inc has an immediate full-time position open for Pharmaceutical & Medical Device Regulatory Affairs Director.
To apply, visit www.collidion.com/careers
Founded in 2015, Collidion, Inc. is a private healthcare company with two subsidiaries, Avenlogics, Inc. and Plex Pharmaceuticals. Collidion strives to improve the future of global healthcare through the acquisition, licensing, development, and commercialization of drugs and medical devices for various markets. Collidion invests industry expertise and capital to develop these technologies into recognizable solutions for patients and medical professionals. Collidion values innovation, scientific rigor, collaboration and a passion for change.
Avenlogics, Inc., Collidion’s subsidiary, is focused on the development and commercialization of several anti-infective based products. The Company’s pipeline of antimicrobial products addresses a growing need for alternative therapies to effectively treat infections caused by antimicrobial resistant pathogens. Collidion’s solutions include several antimicrobial platforms with potential applications in human and animal medicines, wound care, surface disinfection, and improved safety for the food supply chain. The company is located alongside with Collidion, Inc in Petaluma, CA.
Plex Pharmaceuticals is a scientifically-driven company with a vision to improve the lives of patients with complex diseases and conditions. The company is focused on the treatment of diseases generally caused by protein misfolding: ALS, Parkinson’s disease, and cataracts. The company was founded in 2009. Plex has a rich pipeline of drug discovery programs and a dedicated scientific team. Plex’s drug discovery lab and operations are located in San Diego, California.
PHARMACEUTICAL AND MEDICAL DEVICE REGULATORY AFFAIRS DIRECTOR
- Regulatory representation and leadership to cross-functional product development teams, development of regulatory strategies and support for clinical and non-clinical development programs and marketing applications.
- Responsible for project timelines and management of 510K, PMA, IND, NDA and global regulatory submissions.
- Lead regulatory activities including planning and reviewing of CMC, clinical and nonclinical sections of regulatory submissions.
- Plan, direct and prepare regulatory submissions (IND, NDA, IDE, 510(k), PMA) to ensure compliance with FDA and international regulations and guidelines.
- Develop and maintain SOPs with an emphasis on drug and device regulations.
- Perform research regarding regulatory strategic recommendations, and new and revised governmental regulations.
- Conduct successful negotiations and interactions with domestic and foreign regulatory agencies on assigned projects.
- Provide regulatory guidance with regard to preparation, review and approval of labeling and promotional materials.
- Prepare and assist with applicable regulatory audits.
- Statistical techniques.
- Minimum of B.S. in life sciences, engineering, or equivalent required.
- Advanced degree preferred.
- Minimum 5-7 years of experience in regulatory affairs for pharmaceutical and medical device biopharmaceutical companies.
- Veterinary product experience highly desirable.
- Experience with successful FDA and international agency negotiations and audits.
- Experience in developing and submitting successful 510(k), PMA, IND/NDA submissions with a thorough understanding of the drug and device development processes, FDA regulations and ICH guidelines.
- Excellent verbal and written communication skills.
- Detail oriented with well-developed organizational and analytical skills.
- Experience with submitting documents in CTD and eCTD format.
- Suited to working in a fast-paced, small company environment.
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