Sr. Director, Regulatory Affairs - CMC & Reg. Sciences, Biopharma
Meitheal Pharmaceuticals, Inc., Chicago, IL, United States
Job Type
Full-time
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 match
Competitive PTO and company‑paid holidays
Paid parental leave (maternity & paternity)
Onsite gym
Hybrid work schedule
The pay range for this position is $230,000.00 to $290,000.00. Payrate is determined by considering a person's prior experience, skills and knowledge.
Summary The Senior Director of Regulatory Affairs‑CMC & Regulatory Sciences, Biopharma, will be responsible for managing regulatory CMC work for biopharmaceuticals (biologics and biosimilars). The incumbent will work closely with cross‑functional teams within the company and across business partners, as well as with senior leadership, to develop regulatory strategies for projects and portfolios in BioPharma, contributing to the transformation and growth of the regulatory team to meet the needs of the company's business growth toward biopharmaceuticals.
Job Responsibilities
Manage RA deliverables for biosimilar projects.
Pursue regulatory excellence and optimize cross‑functional / across‑site work process in submissions for both quality and efficiency.
Track and interpret new guidance and requirements for biosimilars and assess their impact on new product submissions and approvals, including expertise, timeline and budgeting.
Represent the regulatory function on cross‑functional teams for biosimilars.
Prepare, review meeting packages and submissions to U.S. FDA, including BIA, BPD, INDs, BLAs, etc.
Lead preparation and manage meetings with health authorities, such as U.S. FDA.
Serve as an interface with other partners and consulting services.
Contribute to launch readiness and marketing by guiding the project team on the most appropriate regulatory approach toward approvals and provide post‑market support.
Provide due diligence and review documents from global business partners.
Contribute to portfolio and pipeline selection and prioritization.
Work closely with management team of regulatory affairs department to identify gaps and build competence and capacity for biosimilar and biologics.
Provide training on CMC and regulatory sciences for biologics and biosimilar within RA department and cross‑functions.
Supervisory responsibilities: 2–5 direct reports.
Competencies
Planning and Organizing
Teamwork
Problem Solving
Quality
Judgement
Dependability
Strong Interpersonal Skills
Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Education and/or Experience:
Master or Ph.D. degree in life sciences; over 10 years related experience in pharmaceutical or biotech industry, in areas of development, regulatory strategy, and/or regulatory CMC, with minimum of 5 years in management/supervisory roles, or equivalent combination of education and experience. Expertise in and experience with biologics/biosimilars and/or combination products, human factor or clinical studies are highly preferred. Experience with multiple cultural, global working teams would be a plus.
Language Skills:
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. 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 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.
Travel Occasional travel expected - less than 10%
Computer Skills Microsoft Office, Adobe Systems (Pro, Acrobat DC), etc.
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.
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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 match
Competitive PTO and company‑paid holidays
Paid parental leave (maternity & paternity)
Onsite gym
Hybrid work schedule
The pay range for this position is $230,000.00 to $290,000.00. Payrate is determined by considering a person's prior experience, skills and knowledge.
Summary The Senior Director of Regulatory Affairs‑CMC & Regulatory Sciences, Biopharma, will be responsible for managing regulatory CMC work for biopharmaceuticals (biologics and biosimilars). The incumbent will work closely with cross‑functional teams within the company and across business partners, as well as with senior leadership, to develop regulatory strategies for projects and portfolios in BioPharma, contributing to the transformation and growth of the regulatory team to meet the needs of the company's business growth toward biopharmaceuticals.
Job Responsibilities
Manage RA deliverables for biosimilar projects.
Pursue regulatory excellence and optimize cross‑functional / across‑site work process in submissions for both quality and efficiency.
Track and interpret new guidance and requirements for biosimilars and assess their impact on new product submissions and approvals, including expertise, timeline and budgeting.
Represent the regulatory function on cross‑functional teams for biosimilars.
Prepare, review meeting packages and submissions to U.S. FDA, including BIA, BPD, INDs, BLAs, etc.
Lead preparation and manage meetings with health authorities, such as U.S. FDA.
Serve as an interface with other partners and consulting services.
Contribute to launch readiness and marketing by guiding the project team on the most appropriate regulatory approach toward approvals and provide post‑market support.
Provide due diligence and review documents from global business partners.
Contribute to portfolio and pipeline selection and prioritization.
Work closely with management team of regulatory affairs department to identify gaps and build competence and capacity for biosimilar and biologics.
Provide training on CMC and regulatory sciences for biologics and biosimilar within RA department and cross‑functions.
Supervisory responsibilities: 2–5 direct reports.
Competencies
Planning and Organizing
Teamwork
Problem Solving
Quality
Judgement
Dependability
Strong Interpersonal Skills
Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Education and/or Experience:
Master or Ph.D. degree in life sciences; over 10 years related experience in pharmaceutical or biotech industry, in areas of development, regulatory strategy, and/or regulatory CMC, with minimum of 5 years in management/supervisory roles, or equivalent combination of education and experience. Expertise in and experience with biologics/biosimilars and/or combination products, human factor or clinical studies are highly preferred. Experience with multiple cultural, global working teams would be a plus.
Language Skills:
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. 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 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.
Travel Occasional travel expected - less than 10%
Computer Skills Microsoft Office, Adobe Systems (Pro, Acrobat DC), etc.
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.
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