J&J Family of Companies
Associate Director, CMC Regulatory Affairs
J&J Family of Companies, Lincoln, Nebraska, United States, 68511
J&J Family of Companies - Associate Director, CMC Regulatory Affairs
Johnson & Johnson is recruiting for an Associate Director, CMC Regulatory Affairs. This position can be located in Spring House, PA; Horsham, PA; Titusville, NJ; Raritan, NJ; Beerse, Belgium or Leiden, Netherlands. Remote work options may be considered on a case-by-case basis and if approved by the Company.DescriptionJohnson & Johnson is looking for an individual with expertise in parenteral and general pharmaceutical development to guide the CMC and regulatory aspects of development and commercialization. This person is responsible for developing global CMC regulatory strategies. The primary responsibility is to work on CMC regulatory activities related to but not limited to parenterals. The role involves working in product development and post marketing applications in global markets. The individual will support CMC teams and provide input on the interpretation and application of global CMC regulations and strategic guidance. The ideal candidate will have knowledge about the country specific requirements needed to support IND/IMPD during clinical development as well as during marketing applications globally.Key Responsibilities:Provides guidance and expertise to the Global Regulatory Team to develop global submission plans that comply with local regulatory requirements and commitments.Develops and executes CMC regulatory strategies that support the development of the products in which the candidate is responsible for.Provides regulatory and technical expertise and input to the CMC team to facilitate successful product development globally.Leads the preparation of regulatory dossiers for submission to Health Authorities.Provides technical expertise and technical input in the preparation and writing (as applicable) of regulatory dossiers for submission to Health Authorities globally.Has experience with writing/reviewing briefing books & responding to questions from the Health Authorities.Has participated in Health Authority meetings and has experience in drafting questions and company position for the Health Authorities.Assesses manufacturing changes and evaluates the impact on marketing applications.Works closely with supply chain to ensure continuity of product.May lead selected initiatives within the department.Participates in and conducts due diligence/licensing evaluations as needed.Drives a culture of continuous improvement to ensure compliance with Johnson and Johnson standards, regulatory requirements and expectations. Communicates critical issues to Management.QualificationsEducation:Minimum of Bachelor's degree in biological, pharmaceutical, chemical or engineering sciences with generally a minimum of 10 years of experience inclusive of post graduate education and/or pharmaceutical or health care industry experience or equivalent is required. An MS, Ph.D., or Pharm. D. degree preferred.Experience and Skills:Demonstrated ability to communicate regulatory requirements.Solid understanding of biology, chemistry and/or engineering relevant to pharmaceutical industry, parenteral experience preferred.Experience developing regulatory strategies and an understanding of product development, seen as an expert on product development and how it is applied in global regulatory strategy.Strong attention to detail with high-level verbal and written communication skills.Communicates cross-functionally and cross-company. Presents and defends CMC management-approved regulatory strategy and opinion to project teams.Demonstrates model behavior that understands what the priorities are and encourages others to drive for results.Experience leading interactions with Health Authorities under supervision of a senior member of the CMC RA staff.Strong knowledge of global HA laws, regulations, guidance and regulation submission routes available for assigned products.Good understanding of competitors in the area and what they are doing in early/late development.Compensation and Benefits:The anticipated base pay range for this position is $135,000 to $232,300. Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year.Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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Johnson & Johnson is recruiting for an Associate Director, CMC Regulatory Affairs. This position can be located in Spring House, PA; Horsham, PA; Titusville, NJ; Raritan, NJ; Beerse, Belgium or Leiden, Netherlands. Remote work options may be considered on a case-by-case basis and if approved by the Company.DescriptionJohnson & Johnson is looking for an individual with expertise in parenteral and general pharmaceutical development to guide the CMC and regulatory aspects of development and commercialization. This person is responsible for developing global CMC regulatory strategies. The primary responsibility is to work on CMC regulatory activities related to but not limited to parenterals. The role involves working in product development and post marketing applications in global markets. The individual will support CMC teams and provide input on the interpretation and application of global CMC regulations and strategic guidance. The ideal candidate will have knowledge about the country specific requirements needed to support IND/IMPD during clinical development as well as during marketing applications globally.Key Responsibilities:Provides guidance and expertise to the Global Regulatory Team to develop global submission plans that comply with local regulatory requirements and commitments.Develops and executes CMC regulatory strategies that support the development of the products in which the candidate is responsible for.Provides regulatory and technical expertise and input to the CMC team to facilitate successful product development globally.Leads the preparation of regulatory dossiers for submission to Health Authorities.Provides technical expertise and technical input in the preparation and writing (as applicable) of regulatory dossiers for submission to Health Authorities globally.Has experience with writing/reviewing briefing books & responding to questions from the Health Authorities.Has participated in Health Authority meetings and has experience in drafting questions and company position for the Health Authorities.Assesses manufacturing changes and evaluates the impact on marketing applications.Works closely with supply chain to ensure continuity of product.May lead selected initiatives within the department.Participates in and conducts due diligence/licensing evaluations as needed.Drives a culture of continuous improvement to ensure compliance with Johnson and Johnson standards, regulatory requirements and expectations. Communicates critical issues to Management.QualificationsEducation:Minimum of Bachelor's degree in biological, pharmaceutical, chemical or engineering sciences with generally a minimum of 10 years of experience inclusive of post graduate education and/or pharmaceutical or health care industry experience or equivalent is required. An MS, Ph.D., or Pharm. D. degree preferred.Experience and Skills:Demonstrated ability to communicate regulatory requirements.Solid understanding of biology, chemistry and/or engineering relevant to pharmaceutical industry, parenteral experience preferred.Experience developing regulatory strategies and an understanding of product development, seen as an expert on product development and how it is applied in global regulatory strategy.Strong attention to detail with high-level verbal and written communication skills.Communicates cross-functionally and cross-company. Presents and defends CMC management-approved regulatory strategy and opinion to project teams.Demonstrates model behavior that understands what the priorities are and encourages others to drive for results.Experience leading interactions with Health Authorities under supervision of a senior member of the CMC RA staff.Strong knowledge of global HA laws, regulations, guidance and regulation submission routes available for assigned products.Good understanding of competitors in the area and what they are doing in early/late development.Compensation and Benefits:The anticipated base pay range for this position is $135,000 to $232,300. Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year.Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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