Position: Director - Regulatory Affairs
Role Summary:
Lead regulatory strategy and submissions.
Collaborate with R&D, Technical Ops, Clin Dev, etc. to advance the company’s drug portfolio in order to ensure commercial success.
Responsibilities:
- Guide development programs to meet both US and global regulatory standards.
- Provide strategic regulatory direction from product concept through market launch.
- Shape new regulatory pathways in order to benefit stakeholders.
Requirements:
- 7–12 years of regulatory experience in the pharmaceutical/biopharmaceutical industry.
- Proven track record in regulatory leadership, including 505(b)(1), 505(b)(2), 505(j), etc.
- Experience in filing and obtaining FDA and international approvals.
- Strong regulatory knowledge of drug development including CMC, preclinical, clinical, and post-marketing phases.
- Experience working with FDA and other regulatory bodies.
1.Coach clients in positive boxing ethics and training concepts & methods.2.Develop professional and customized boxing, fighting, and other fitness training plans for clients.3.Demonstrate a strong sense of responsibility and adhere to standardized boxing coaching....
...records to obtain facts to resolve all material issues in a case or to establish the background, reputation, character, suitability, or qualifications of the subject under investigation. Independent Contractors are not employees and have the ability to accept and...
...The Inbound Marketing Team Lead is responsible for management of all assigned online marketing campaigns with clients and employees. This... ...could make OneIMS even better Requirements ~ Support SEO and inbound marketing team in research, setup and implementation...
+ View details
Benefits:~401(k) matching~Flexible schedule~Opportunity for advancement~Paid time off~Training & developmentCandidates who take pride in helping others and who enjoy making every room in a home sparkle are encouraged to apply. Bilingual is a plus!If you ...