ProPharma Group
Director, Regulatory Labeling & Development Strategy
ProPharma Group, Western Springs, Illinois, United States, 60558
For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world's largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs.
The
Director,
R
egulatory Labeling and Development Strategist
is responsible for:
Providing Regulatory Labeling expertise and guidance for assigned brands or therapeutic categories in collaboration with cross-functional client stakeholders.Developing and crafting the strategic direction of the labeling component of the regulatory strategy for assigned marketed or pipeline products.Coordinating and overseeing the label development review process.Advising client stakeholders to ensure appropriate project and resource planning.Essential Functions
Ensure the labeling process is followed through the lifecycle of the product.Ensure all work is performed in accordance with established procedures, regulatory requirements and GxPs.
Lead the development of the labeling strategy, in line with the overall regulatory strategy for the product and/or the disease area, by interpretation of regulations, guidance and competitor analyses, anticipating and communicating the wider impacts of the strategy and the long-term consequences for the product.
Lead the Product Labeling Team (PLT) in the preparation and maintenance of high-quality Core Prescribing Information, EU Quality Review of Documents, US Prescribing Information, and Instructions For Use through to client stakeholders approval with the aim of achieving advantageous labeling.
Lead the development of labeling negotiation strategies, anticipating health authority perspectives.
Provide clarity regarding applicable labeling requirements and expectations in complex situations to relevant stakeholders, including risk insight and propose mitigations.
Develop labeling documents, policies, procedures and SOPs
Necessary Skills and Abilities
Strong ability to work independently, with flexibility and a strong ability to connect and collaborate with client stakeholders while working remotely.
Ability to justify and communicate the labeling rationale to client stakeholders to enable effective decision-making.
Ability to provide labeling expertise to the Regulatory teams and PLT for assigned products regarding language, placement and regulatory content detail for CPI and MPI in line with client procedures, regional labeling regulations and guidance.
Evaluate, interpret and communicate global regulations and trends on labeling and any business impact these might have on product labeling.
Proven ability to provide strategic direction and innovative, forward thinking.
Working knowledge of FDA and Pharmaceutical regulatory and compliance labeling guidelines.
Deep understanding of strategic regulatory labeling process.
Proficiency in computer applications and configuration, including Microsoft Office, Adobe Acrobat. - Proficiency in Veeva Vault Promo Mats or other electronic review platforms.
Educational Requirements
A Bachelor's degree is required, focus in Business, Medical, Science, Marketing, Business or Communications; a PharmD is preferred.
Experience Requirements
10+ years of related experience in the pharmaceutical/ biotech industry is required.
Strong project and process management experience is required, in pharmaceutical industry is preferred.
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
The
Director,
R
egulatory Labeling and Development Strategist
is responsible for:
Providing Regulatory Labeling expertise and guidance for assigned brands or therapeutic categories in collaboration with cross-functional client stakeholders.Developing and crafting the strategic direction of the labeling component of the regulatory strategy for assigned marketed or pipeline products.Coordinating and overseeing the label development review process.Advising client stakeholders to ensure appropriate project and resource planning.Essential Functions
Ensure the labeling process is followed through the lifecycle of the product.Ensure all work is performed in accordance with established procedures, regulatory requirements and GxPs.
Lead the development of the labeling strategy, in line with the overall regulatory strategy for the product and/or the disease area, by interpretation of regulations, guidance and competitor analyses, anticipating and communicating the wider impacts of the strategy and the long-term consequences for the product.
Lead the Product Labeling Team (PLT) in the preparation and maintenance of high-quality Core Prescribing Information, EU Quality Review of Documents, US Prescribing Information, and Instructions For Use through to client stakeholders approval with the aim of achieving advantageous labeling.
Lead the development of labeling negotiation strategies, anticipating health authority perspectives.
Provide clarity regarding applicable labeling requirements and expectations in complex situations to relevant stakeholders, including risk insight and propose mitigations.
Develop labeling documents, policies, procedures and SOPs
Necessary Skills and Abilities
Strong ability to work independently, with flexibility and a strong ability to connect and collaborate with client stakeholders while working remotely.
Ability to justify and communicate the labeling rationale to client stakeholders to enable effective decision-making.
Ability to provide labeling expertise to the Regulatory teams and PLT for assigned products regarding language, placement and regulatory content detail for CPI and MPI in line with client procedures, regional labeling regulations and guidance.
Evaluate, interpret and communicate global regulations and trends on labeling and any business impact these might have on product labeling.
Proven ability to provide strategic direction and innovative, forward thinking.
Working knowledge of FDA and Pharmaceutical regulatory and compliance labeling guidelines.
Deep understanding of strategic regulatory labeling process.
Proficiency in computer applications and configuration, including Microsoft Office, Adobe Acrobat. - Proficiency in Veeva Vault Promo Mats or other electronic review platforms.
Educational Requirements
A Bachelor's degree is required, focus in Business, Medical, Science, Marketing, Business or Communications; a PharmD is preferred.
Experience Requirements
10+ years of related experience in the pharmaceutical/ biotech industry is required.
Strong project and process management experience is required, in pharmaceutical industry is preferred.
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***