Ipsen Pharma
Director, Regulatory Operations
Ipsen Pharma, Cambridge, Massachusetts, us, 02140
Title:Director, Regulatory Operations
Company:Ipsen Biopharmaceuticals Inc.
Job Description:
Director, US Regulatory Operations
Summary / purpose of the position
The Director of US Regulatory Operations (RegOps) is responsible for formulating and implementing operational management creating a best- in -class US regulatory operations team and technology leadership/ownership (Veeva PromoDocs) of Ipsen's Advertising/Promotion and Labeling submissions along with associated tools. In addition, this role will influence and drive US regulatory standards through enterprise-wide partnerships. The role has two major components, the responsibilities of which can be defined as follows.
A) Regulatory Informatics and Analytics: In this capacity, the individual serves as the regulatory point of contact and is accountable in partnership with Global IT and Global business system owner for the development, implementation, and governance of US regulatory system (Veeva PromoDocs), tools, and processes (subpart H, 2253, and US labeling) meeting FDA requirements. Working enterprise wide to establish and maintain long range plans for new pieces coming to PRC to enable better resource planning, identify/influence, and drive process improvements.
B) Regulatory Project Management, AdPromo/US labeling Submission and Publishing: In this capacity, the person is accountable for project management, applicable regulatory submissions; working with internal and external Subject Matter Experts (SMEs) on defined deliverables; electronic submission standards utilizing applicable FDA eSub guidances, interfacing with Ipsen's internal publisher(s) on submission documents; establishing US facing Standard Operating Procedures (SOPs) and Work Instructions (WIS), and training cross-functionally on regulatory processes and systems as needed.
Main responsibilities / job expectations
Responsibilities will include, but are not limited to the following:Be a strategic thought partner to the VP US Regulatory and Quality about complex problems, current and future initiatives, organization, strategies, and budgets.Serves as member of the US Regulatory and Quality leadership team providing guidance and influencing the departmental operation/future vision.Look across teams to identify synergies and interdependencies to ensure optimal working model.Monitor PRC KPIs, providing support and partnering with Coordinators as necessary to ensure that remain on track. Providing insight for future planning. Informatics: establishing meaningful KPI's, MRC calendars to enable better resource planning,Expert in current and new technologies and their application(s) within the US Ad/Promo/Labeling function that can lead to greater efficiencies within our processes.Define functional needs and partner with global IT and global business system owner on needed VEEVA PromoDocs upgrades, lead associated validation requirements.Evaluate in collaboration with global IT new tools and potential AI applications leading to greater efficiencies.Provide expertise in efficiencies and in process mapping to guide scaling decisions.Works with VP US RA and QA on budget management.Collaborates cross departmentally and within US organization on Design Space vs. PRC (regulated space) with our franchises and internal stakeholders.Prepares monthly dashboard updates.Maintains PRC SharePoint site.Strong partner with PRC teams to own copy editing, QC, submission prep for SubPart H and 2253, materials for FDA maintaining high quality submission standards. Owns US SPL submissions and maintenance.Attends PRC meetings to gain insight into products and materials for future submissions.Strong partner within US RA and QA, Global RA, and our cross functional US stakeholders.Owns the submission process to FDA for SPLs (labeling) and ad promo ensuring eSub standards are met.Partners with coordinators and Reviewers on establishing /editing local SOPs, work instructions, and guides. Leads efforts to update/maintain current and new documents as needed based on ongoing process efficiency assessment(s).Coach and mentor associates, provide work oversight, prioritize work, and manage timelines.Knowledge, abilities & experience
Education / Certifications:
B.A./B.S. degree in life sciences or technical writing.Experience:
15+ years of direct regulatory experience in biotechnology environment.3+ years management experience.Excellent working knowledge of FDA regulations and ICH guidelines.Excellent written and interpersonal communication skills. Outstanding communicator, able to persuasively convey both ideas and data, verbally and in writing.Ability to lead and work with others in a positive and collaborative manner.Proficient experience with electronic submissions and electronic Common Technical Document (eCTD) structure with submission publishing software.Experience with Electronic Data Management Systems (EDMS) and regulatory documentation archival required. Must have experience with evaluating and implementing new systems in addition to system upgrades.Proven record of implementing regulatory process transformation and organizational culture change.Role models respect and inclusion, creating a culture that fosters innovation. Cultivates relationships throughout Ipsen.Proficient experience with submission publishing software and tools. Veeva PromoDocs.Proficient use of MS Office and Adobe suites.Languages:
Fluent in EnglishKey Technical Competencies Required
Excellent written and oral communication skills and delivers all communication with clarity and impact. Commands attention through a range of communication styles.Strong organizational and project management skills. Able to develop and implement short to long-term plans or delivery of small to large scale projects.Shows a constant focus on improving performance and excellence in all tasks. Challenges and questions ways of working to seek improved process.Ability to influence and interact effectively across relevant functions internally and externally.Consistent ability to foster strong matrix working. Proven track record of facilitating groups of individuals to work together on innovative solutions.Be an innovator of new ideas and best practices.Must anticipate and solve problems.Recognized as a leader, team player, and possess a cross-functional collaborative skill set.Ability to manage multiple activities or projects.Excellent interpersonal and negotiation skills with an ability to build networks within Ipsen and use them to secure appropriate support and outcome for a project.Highly proficient in FDA electronic submission standards.Highly proficient in regulatory technologies.
The annual base salary range for this position is $177,000-$259,600.
This job is eligible to participate in our short-term incentives program as well as our long-term incentives program.
At Ipsen we are proud to offer a comprehensive employee benefits package, including 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, short- and long-term disability insurance, as well as flexible spending accounts. Ipsen also provides parental leave, paid time off, a discretionary winter shutdown, well-being allowance, commuter benefits, and much more.
The pay range displayed above is the range of base pay compensation within which Ipsen expects to pay for this role at the time of this posting. Individual compensation within this range depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and demonstrated skills.
IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
Company:Ipsen Biopharmaceuticals Inc.
Job Description:
Director, US Regulatory Operations
Summary / purpose of the position
The Director of US Regulatory Operations (RegOps) is responsible for formulating and implementing operational management creating a best- in -class US regulatory operations team and technology leadership/ownership (Veeva PromoDocs) of Ipsen's Advertising/Promotion and Labeling submissions along with associated tools. In addition, this role will influence and drive US regulatory standards through enterprise-wide partnerships. The role has two major components, the responsibilities of which can be defined as follows.
A) Regulatory Informatics and Analytics: In this capacity, the individual serves as the regulatory point of contact and is accountable in partnership with Global IT and Global business system owner for the development, implementation, and governance of US regulatory system (Veeva PromoDocs), tools, and processes (subpart H, 2253, and US labeling) meeting FDA requirements. Working enterprise wide to establish and maintain long range plans for new pieces coming to PRC to enable better resource planning, identify/influence, and drive process improvements.
B) Regulatory Project Management, AdPromo/US labeling Submission and Publishing: In this capacity, the person is accountable for project management, applicable regulatory submissions; working with internal and external Subject Matter Experts (SMEs) on defined deliverables; electronic submission standards utilizing applicable FDA eSub guidances, interfacing with Ipsen's internal publisher(s) on submission documents; establishing US facing Standard Operating Procedures (SOPs) and Work Instructions (WIS), and training cross-functionally on regulatory processes and systems as needed.
Main responsibilities / job expectations
Responsibilities will include, but are not limited to the following:Be a strategic thought partner to the VP US Regulatory and Quality about complex problems, current and future initiatives, organization, strategies, and budgets.Serves as member of the US Regulatory and Quality leadership team providing guidance and influencing the departmental operation/future vision.Look across teams to identify synergies and interdependencies to ensure optimal working model.Monitor PRC KPIs, providing support and partnering with Coordinators as necessary to ensure that remain on track. Providing insight for future planning. Informatics: establishing meaningful KPI's, MRC calendars to enable better resource planning,Expert in current and new technologies and their application(s) within the US Ad/Promo/Labeling function that can lead to greater efficiencies within our processes.Define functional needs and partner with global IT and global business system owner on needed VEEVA PromoDocs upgrades, lead associated validation requirements.Evaluate in collaboration with global IT new tools and potential AI applications leading to greater efficiencies.Provide expertise in efficiencies and in process mapping to guide scaling decisions.Works with VP US RA and QA on budget management.Collaborates cross departmentally and within US organization on Design Space vs. PRC (regulated space) with our franchises and internal stakeholders.Prepares monthly dashboard updates.Maintains PRC SharePoint site.Strong partner with PRC teams to own copy editing, QC, submission prep for SubPart H and 2253, materials for FDA maintaining high quality submission standards. Owns US SPL submissions and maintenance.Attends PRC meetings to gain insight into products and materials for future submissions.Strong partner within US RA and QA, Global RA, and our cross functional US stakeholders.Owns the submission process to FDA for SPLs (labeling) and ad promo ensuring eSub standards are met.Partners with coordinators and Reviewers on establishing /editing local SOPs, work instructions, and guides. Leads efforts to update/maintain current and new documents as needed based on ongoing process efficiency assessment(s).Coach and mentor associates, provide work oversight, prioritize work, and manage timelines.Knowledge, abilities & experience
Education / Certifications:
B.A./B.S. degree in life sciences or technical writing.Experience:
15+ years of direct regulatory experience in biotechnology environment.3+ years management experience.Excellent working knowledge of FDA regulations and ICH guidelines.Excellent written and interpersonal communication skills. Outstanding communicator, able to persuasively convey both ideas and data, verbally and in writing.Ability to lead and work with others in a positive and collaborative manner.Proficient experience with electronic submissions and electronic Common Technical Document (eCTD) structure with submission publishing software.Experience with Electronic Data Management Systems (EDMS) and regulatory documentation archival required. Must have experience with evaluating and implementing new systems in addition to system upgrades.Proven record of implementing regulatory process transformation and organizational culture change.Role models respect and inclusion, creating a culture that fosters innovation. Cultivates relationships throughout Ipsen.Proficient experience with submission publishing software and tools. Veeva PromoDocs.Proficient use of MS Office and Adobe suites.Languages:
Fluent in EnglishKey Technical Competencies Required
Excellent written and oral communication skills and delivers all communication with clarity and impact. Commands attention through a range of communication styles.Strong organizational and project management skills. Able to develop and implement short to long-term plans or delivery of small to large scale projects.Shows a constant focus on improving performance and excellence in all tasks. Challenges and questions ways of working to seek improved process.Ability to influence and interact effectively across relevant functions internally and externally.Consistent ability to foster strong matrix working. Proven track record of facilitating groups of individuals to work together on innovative solutions.Be an innovator of new ideas and best practices.Must anticipate and solve problems.Recognized as a leader, team player, and possess a cross-functional collaborative skill set.Ability to manage multiple activities or projects.Excellent interpersonal and negotiation skills with an ability to build networks within Ipsen and use them to secure appropriate support and outcome for a project.Highly proficient in FDA electronic submission standards.Highly proficient in regulatory technologies.
The annual base salary range for this position is $177,000-$259,600.
This job is eligible to participate in our short-term incentives program as well as our long-term incentives program.
At Ipsen we are proud to offer a comprehensive employee benefits package, including 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, short- and long-term disability insurance, as well as flexible spending accounts. Ipsen also provides parental leave, paid time off, a discretionary winter shutdown, well-being allowance, commuter benefits, and much more.
The pay range displayed above is the range of base pay compensation within which Ipsen expects to pay for this role at the time of this posting. Individual compensation within this range depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and demonstrated skills.
IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.