 |
|
AD Regulatory Affairs Oncology(3 openings)
Develop and guide the regulatory strategy for the approval of assigned Oncology products.
Aid and supervise the preparation of regulatory submissions in the US, Canada, and Latin America.
Serve as the Regulatory International Product Team (IPT) member for Oncology and provide regulatory leadership.
Monitor Oncology programs so they comply with the required Health Authority Regulations and Laws.
Interact with Health Authorities to address regulatory issues and to maintain the product development plan on schedule.
Coordinate regulatory project activities with global counterparts.
BS degree required in associated functional discipline (Life Sciences, Chemistry, Toxicology, Pharmacology, Pharmacy or Nursing). PhD, PharmD, or comparable degree in the life sciences highly desired.
Associate Director: Minimum 10-12 years of regulatory experience plus 2-3 years of additional related experience (i.e., clinical development, medical writing, medical affairs).
Must have experience in interacting with the appropriate regulatory bodies and in Oncology Drug Development.
Must possess in-depth knowledge of appropriate Code of Federal Regulations, Regulatory Guidance Documents and ICH Regulations.
Experience with electronic submissions highly desirable and having completed filings (i.e., NDA’s, BLA’s, IND’s) to health authorities.
History of working in complex team environments with numerous/diverse stakeholders.
120k to 150k DOE and 20% bonus with Executive Bonus also
contact
Jamie@Pharmasearchpartners.com
|
| Additional Information |
Salary: $120000 to $150000 Per Year
Position Type:
Employee
Ref Code: jcr001 |
|
|
|
|
