Merck Gruppe
Field Regulatory Specialist
Merck Gruppe - Madison, Wisconsin, us, 53774
Work at Merck Gruppe
Overview
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Overview
Work Location: Madison, Wisconsin
If the following job requirements and experience match your skills, please ensure you apply promptly. Shift: No Department: LS-PS-JC Field Application & Support Recruiter:Paul Therrien
This information is for internals only. Please do not share outside of the organization.
Your role: Regulatory Guidance: Provide expert advice to customers on the regulatory considerations for the use of transfection reagents and/or enhancer products as ancillary materials in cell and gene therapy applications. Customer Engagement: Act as the primary regulatory point of contact for customers, helping them navigate regulatory questions and challenges related to FDA IND filings and commercial manufacturing. Risk Mitigation: Develop supporting collateral and communicate strategies to mitigate regulatory risks for customers using our products in their manufacturing processes. Collaboration: Partner with field application scientists and account managers to ensure alignment in customer interactions and provide integrated technical-regulatory support. Regulatory Compliance: Stay updated on global regulatory requirements and guidelines (e.g., FDA, EMA, ICH) for ancillary materials and ensure our recommendations are in line with current standards. Documentation Support: Present Mirus regulatory documentation to customers (e.g. Regulatory Support Package and/or Product Safety Risk Assessment- Supplemental Information). Assist customers in preparing documentation to support regulatory submissions, including technical dossiers, risk assessments, and compliance statements. Training & Education: Conduct training sessions for internal teams and customers on regulatory expectations and best practices for ancillary materials in the field of viral vector therapy. Stakeholder Liaison: Represent the company during interactions with regulatory bodies as needed, supporting customers in regulatory audits or inquiries. Fully remote opportunity Who you are Mimimum Qualifications: Bachelor’s degree in a relevant scientific field (e.g., Biology, Biochemistry, Biotechnology, etc) Specialized regulatory training or certifications (e.g., RAC - Regulatory Affairs Certification) 3+ years of experience in regulatory affairs, preferably in the biopharmaceutical or cell and gene therapy industries In-depth knowledge of FDA, EMA, and other global regulatory requirements for ancillary materials and viral vector production Strong understanding of GMP, IND filing processes, and commercial manufacturing considerations Experiece with regulatory agencies andauthorities like the FDA or EMA Preferred Qualifications: Advanced degree preferred CMC experience preferred Exceptional communication and interpersonal skills, with the ability to explain complex regulatory concepts clearly and effectively to internal stakeholders, including R&D, quality assurance, and legal teams Ability to identify and manage risks associated with CGT products, particularly long-term safety and monitoring requirements. Understanding of adverse event reporting and pharmacovigilance as it pertains to CGT, including post-market surveillance. Experience working directly with CGT products, such as viral vector-based gene therapies, CAR-T therapies, or stem cell therapies Proven ability to work cross-functionally in a fast-paced, customer-focused environment Experience with risk assessments and regulatory submissions Remote role, can be based anywhere in the US. Ideally MA, CA, MO, NC, PA Our ranges are derived from several sources, and largely reliant on relevant industry market data. Should we decide to make an offer, we will consider several factors, including but not limited to your location, skills, experience, career level, and other job-related factors. This role may offer the following benefits: medical, vision, and dental insurance; life insurance; disability insurance; a 401(k) matching program; paid time off; and paid holidays; among other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including, but not limited to, cash bonuses Pay range for this position: $101,500-$152,300
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
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If the following job requirements and experience match your skills, please ensure you apply promptly. Shift: No Department: LS-PS-JC Field Application & Support Recruiter:Paul Therrien
This information is for internals only. Please do not share outside of the organization.
Your role: Regulatory Guidance: Provide expert advice to customers on the regulatory considerations for the use of transfection reagents and/or enhancer products as ancillary materials in cell and gene therapy applications. Customer Engagement: Act as the primary regulatory point of contact for customers, helping them navigate regulatory questions and challenges related to FDA IND filings and commercial manufacturing. Risk Mitigation: Develop supporting collateral and communicate strategies to mitigate regulatory risks for customers using our products in their manufacturing processes. Collaboration: Partner with field application scientists and account managers to ensure alignment in customer interactions and provide integrated technical-regulatory support. Regulatory Compliance: Stay updated on global regulatory requirements and guidelines (e.g., FDA, EMA, ICH) for ancillary materials and ensure our recommendations are in line with current standards. Documentation Support: Present Mirus regulatory documentation to customers (e.g. Regulatory Support Package and/or Product Safety Risk Assessment- Supplemental Information). Assist customers in preparing documentation to support regulatory submissions, including technical dossiers, risk assessments, and compliance statements. Training & Education: Conduct training sessions for internal teams and customers on regulatory expectations and best practices for ancillary materials in the field of viral vector therapy. Stakeholder Liaison: Represent the company during interactions with regulatory bodies as needed, supporting customers in regulatory audits or inquiries. Fully remote opportunity Who you are Mimimum Qualifications: Bachelor’s degree in a relevant scientific field (e.g., Biology, Biochemistry, Biotechnology, etc) Specialized regulatory training or certifications (e.g., RAC - Regulatory Affairs Certification) 3+ years of experience in regulatory affairs, preferably in the biopharmaceutical or cell and gene therapy industries In-depth knowledge of FDA, EMA, and other global regulatory requirements for ancillary materials and viral vector production Strong understanding of GMP, IND filing processes, and commercial manufacturing considerations Experiece with regulatory agencies andauthorities like the FDA or EMA Preferred Qualifications: Advanced degree preferred CMC experience preferred Exceptional communication and interpersonal skills, with the ability to explain complex regulatory concepts clearly and effectively to internal stakeholders, including R&D, quality assurance, and legal teams Ability to identify and manage risks associated with CGT products, particularly long-term safety and monitoring requirements. Understanding of adverse event reporting and pharmacovigilance as it pertains to CGT, including post-market surveillance. Experience working directly with CGT products, such as viral vector-based gene therapies, CAR-T therapies, or stem cell therapies Proven ability to work cross-functionally in a fast-paced, customer-focused environment Experience with risk assessments and regulatory submissions Remote role, can be based anywhere in the US. Ideally MA, CA, MO, NC, PA Our ranges are derived from several sources, and largely reliant on relevant industry market data. Should we decide to make an offer, we will consider several factors, including but not limited to your location, skills, experience, career level, and other job-related factors. This role may offer the following benefits: medical, vision, and dental insurance; life insurance; disability insurance; a 401(k) matching program; paid time off; and paid holidays; among other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including, but not limited to, cash bonuses Pay range for this position: $101,500-$152,300
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
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