Sr. Associate, Regulatory Affairs - CMC & Reg. Sciences
MEITHEAL PHARMACEUTICALS, INC, Chicago, IL, United States
Position Summary
The Sr. Associate, Regulatory Affairs – CMC & Regulatory Sciences is responsible for supporting, preparing and reviewing submissions, deficiency reports and FDA meeting packages, aiming for high-quality regulatory submissions and fast approvals. S/he will work closely with other teams in the Regulatory department and cross-functionally, as well as with product development, manufacturing and regulatory partners, contributing to the transformation and growth of the regulatory team to meet the needs of company's business growth of biopharmaceuticals.
Essential Duties and Responsibilities
Support, prepare, and review communication documents & submissions to the agencies, including controlled correspondences, FDA meeting packages (Pre-ANDA, Pre-IND, BIA, BPD2/3/4, etc.), and submissions (IND, NDAs, ANDAs, BLA).
Address complex and technical issues with solid scientific rationalization, with or without supervision.
Identify and act on issues and risks from regulatory perspective, especially for complex generics and biosimilars.
Provide regulatory assessments to the company (internal and partners), including change controls and/or document changes based on ICH and FDA guidelines.
Track deficiency trends and develop proactive and/or mitigation measures accordingly.
Planning and Organizing
Problem Solving
Dependability
Strong Interpersonal Skills
Qualifications Education and/or Experience Bachelor’s or master’s degree in life sciences. 2+ years relevant industry experience in the areas of research and development, or regulatory. Background and experience in biologics or biochemical engineering/biotechnology, pharmaceutical engineering are highly preferred.
Communication Skills Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Mathematical Skills Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Reasoning Ability Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Computer Skills Microsoft Office, Adobe Systems (Pro, Acrobat DC), and Regulatory publishing systems (DocuBridge)
What We Offer
Competitive pay and medical, dental, and vision insurance
Flexible spending accounts
Long- and short-term disability insurance, as well as life insurance
401(k) plan with employer contribution
Competitive PTO and company-paid holidays
Paid parental leave (maternity & paternity)
Hybrid work schedule
The estimated salary range reflects an anticipated range for this position of $75,000 to $105,000.
The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
AAP/EEO Statement Meitheal Pharmaceuticals is an Equal Opportunity Employer. We welcome and encourage applications from all qualified individuals, including minorities, women, veterans, and individuals with disabilities.
#J-18808-Ljbffr
Essential Duties and Responsibilities
Support, prepare, and review communication documents & submissions to the agencies, including controlled correspondences, FDA meeting packages (Pre-ANDA, Pre-IND, BIA, BPD2/3/4, etc.), and submissions (IND, NDAs, ANDAs, BLA).
Address complex and technical issues with solid scientific rationalization, with or without supervision.
Identify and act on issues and risks from regulatory perspective, especially for complex generics and biosimilars.
Provide regulatory assessments to the company (internal and partners), including change controls and/or document changes based on ICH and FDA guidelines.
Track deficiency trends and develop proactive and/or mitigation measures accordingly.
Planning and Organizing
Problem Solving
Dependability
Strong Interpersonal Skills
Qualifications Education and/or Experience Bachelor’s or master’s degree in life sciences. 2+ years relevant industry experience in the areas of research and development, or regulatory. Background and experience in biologics or biochemical engineering/biotechnology, pharmaceutical engineering are highly preferred.
Communication Skills Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Mathematical Skills Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Reasoning Ability Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Computer Skills Microsoft Office, Adobe Systems (Pro, Acrobat DC), and Regulatory publishing systems (DocuBridge)
What We Offer
Competitive pay and medical, dental, and vision insurance
Flexible spending accounts
Long- and short-term disability insurance, as well as life insurance
401(k) plan with employer contribution
Competitive PTO and company-paid holidays
Paid parental leave (maternity & paternity)
Hybrid work schedule
The estimated salary range reflects an anticipated range for this position of $75,000 to $105,000.
The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
AAP/EEO Statement Meitheal Pharmaceuticals is an Equal Opportunity Employer. We welcome and encourage applications from all qualified individuals, including minorities, women, veterans, and individuals with disabilities.
#J-18808-Ljbffr