We are a regulatory consulting company located at Rockville, Maryland USA. We help the pharmaceutical and biotech companies with their regulatory filing of US IND/ BLA/NDA during drug development. We specialize in both small molecule and biologic product regulatory affairs. We are looking for an organic chemist to join our small molecule working group for writing the IND dossiers and marketing application dossiers. The job will start as a contractor and have the potential to convert to a full time W-2 position based on the performance.
The job duties include:
- Write the small molecule process development sections
- Write the synthetic pathway, and process descriptions
- Write the regulatory submission dossiers for small molecule controls and stability studies.
- Work as a regulatory CMC consultant in the group.
- Present the work in the group and to the clients
- Attend FDA meetings
- Master degree or above in organic chemistry
- 0-5 years of working experience
- Excellent communication skills
- Detailed orientated and motivated with self learning capability
- Willing to work with a team
- Capable of presenting the work to the team and clients
- Very proficient in the Microsoft word, ppt and excel
- Can teach the junior members in the team
- Multitask and can work overtime when needed.
- Can physically be on site at Rockville from Monday to Friday.