- Bachelor’s Degree is required, preferably in a scientific discipline.
- Higher level degree (e.g., Master’s, PhD or PharmD) is preferred.
- Regulatory Affairs Certification (RAC) is preferred.
- Minimum of 8-10 years of regulatory affairs experience. Experience in biotechnology or pharmaceutical industry is acceptable.
- Significant hands-on experience in early-stage development programs is highly preferred.
- Experience with designing and executing creative development strategies for New Chemical Entity (NCE) or biologics development programs.
- Experience preparing and overseeing regulatory submissions, including INDs/Clinical Trial Applications and Marketing Applications in electronic Common Technical Document format.
- Experience with international clinical trials and regulatory documentation
- Experience interacting with FDA representatives and organizing FDA meetings.
- Meaningful experience in submission of IND and NDA is a plus. ?
- Comprehensive understanding of FDA regulations and ICH guidance, as well as comprehensive experience in the drug development process.
- Detail-oriented with the ability to detect and correct errors and/or inconsistencies in a variety of documents.
- Excellent communication (written and verbal) and collaboration skills.
- Expertise in translating regulatory requirements into practical, workable plans.
- Experience in preparation of critical submission documentation, and communications with FDA and other regulatory agencies.
- Ability to build effective relationships within a team/collaborative environment, with a high level of professionalism.
- Proven track records working with regulatory agencies.
- Required to travel up to 10% as needed within a global work environment.
Our Value Proposition:
Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits.
MTP provides a competitive benefits package inclusive of Medical and Dental health benefits, short-term and long-term disability plans, Company Paid and Supplemental Life insurance and additional voluntary benefits such as Critical Illness Insurance, Accident Insurance, Legal Plan, and ID Theft Protection. In addition, we provide a generous PTO policy based on tenure, commencing with 24 PTO days, pro-rated based on hire date.
The salary range for this position is $155,000 - $264,000. Factors such as scope and responsibilities of the position, candidate's work experience, education/training, job-related skills, internal peer equity, as well as market and business considerations may influence base pay offered. This salary may be subject to a geographic adjustment (according to a specific city and state and depending on the role), if an authorization is granted to work outside of the location listed in this posting.
This position is eligible to participate in our annual Short-Term Incentive (STI) program. Specific information about the plan including eligibility rules and target, will be furnished upon hire.
This position is eligible to participate in our Long-Term Incentive (LTI) program. Specific information about the plan including eligibility rules and target, will be furnished upon hire.