Featured

Career Opportunities 

Our client is a privately held biopharmaceutical company focused on building a robust pipeline by advancing its proprietary late stage photodynamic therapy product. The Head of Regulatory Affairs will be responsible for managing regulatory submissions and conducting internal and external regulatory/clinical compliance audits in relation to FDA regulations. This role will be immersed in the development and implementation initiatives aimed at enhancing the commercial success of the company. He/She will represent the company at meetings with FDA or other government agencies and provide regulatory input into the selection of strategic product development targets for the Corporation.

  • Responsible and accountable for the strategic direction, leadership, growth, tactical and operational success of the company’s regulatory program and will act as Head of Worldwide Regulatory Affairs for the Company.
  • Develop and implement Global (primary focus on US and EU) regulatory strategies for the company and serve as the lead contact to the FDA and other health authorities.
  • Lead the preparation and submission of worldwide regulatory applications to the FDA / other health authorities (ex-US) supporting clinical development programs and marketing application filings.
  • Create, organize, review and lead the preparation of all pre-filing and pre-approval submissions in accordance with FDA regulations.
  • Filings/Reports include, but are not limited to, IND, CTA, BLA, MAA, annual reports, meeting packages, and other submissions/regulatory communications as required.
  • Review and develop a plan for existing and new draft regulatory guidelines, impact of regulatory trends, risk, as well as compliance requirements. Provide regulatory intelligence and advice on relevant new and existing regulatory strategies.
  • Lead and manage both internal and external Regulatory Affairs teams / vendors. Review current Regulatory Affairs structure and resources, determine and remedy any existing gaps, and develop regulatory SOPs for the company.

SUBSCRIBE UP TO RECEIVE INDUSTRY NEWS

Featured Careers

These Are Only Our Featured Careers

Contact Ashton Tweed For More Open Career Opportunities

Phone: (610) 725-0290
Fax: (610) 975-0291
Email: info@ashtontweed.com

Ashton Tweed, Ltd.
565 E. Swedesford Rd.
Suite 214
Wayne, PA 19087

Share
The FDA has approved the first MRI device specifically for use in neonatal intensive care units. https://t.co/46tSVpbNGt
Vertex reported positive clinical results for three of its cystic fibrosis triple combination treatments! https://t.co/E6uzdznI0s
Mitsubishi Tanabe to acquire NeuroDerm, a drug company focused on treatments for Parkinson's disease, for $1.1B! https://t.co/7hZ5tLbhMq
This biotech needed a CMO to lead all aspects of US & international clinical trial development of pipeline products: https://t.co/zsZBJ9MKNe
Ashton's Tip of the Week: Making introductions is a form of networking. Know two people who might be helpful to one… https://t.co/AxQpT054D5
Quest acquired 2 lab businesses in TX, establishing a national center of excellence for cancer precision diagnostics.https://t.co/YwEA7erRvR
Ex Google exec teams up w/ Mayo Clinic to develop tools to screen for a heart rhythm that kills thousands each year. https://t.co/FRnrbexS0j
#ThrowbackThursday to Gregor Johann Mendel, born this day in 1822, the founder of the modern science of genetics. https://t.co/9tXMewy9O5
A pair of Zika vaccines, given to mice before pregnancy, protected their offspring from Zika infection. https://t.co/ipcDTKUmYg
Sanofi and GSK are beginning shipments for flu season, expecting to dispatch up to 70M and 40M doses respectively. https://t.co/mJMftbGT5q
http://ashtontweed.com/resume-submission-process/