Associate Director, Global Regulatory Labeling

POSITION SUMMARY: 

Global leader (assigned to a Therapeutic Area, product or portfolio) with responsibility for:

• The creation and maintenance of primary and derived labeling documents, and text for artwork for packaging components through the LWG and LC processes, as required

• Ensuring quality of primary and derived labeling documents, and text for artwork for packaging components (e.g., alignment of labeling text with data, regulatory requirements, consistency (where appropriate) between labeling documents)

• Contribution to and implementation of the global labeling strategy including the development of target labeling

• Continuous improvement of the end to end labeling process

Principle Responsibilities, include:

Principal responsibilities may vary depending on level of employee.

Principal responsibilities may include but are not restricted to the following and may vary depending on labeling experience and Therapeutic Area, product or portfolio assignments as determined by the Global Labeling Therapeutic Area Head:

• Responsible for the creation and maintenance of primary (Core Company Data Sheet (CCDS), United States Package Insert (USPI) and associated patient labeling, EU Product Information (EUPI)) and derived (International Package Insert, labeling text for EU, US and international package components, and translations) labeling documents. Takes into account competitor labels when drafting labeling text.

• Coordinates the development, revision, review and approval of primary and derived labeling documents including the Labeling working Group (LWG) and Labeling Committee (LC) activities related to these documents

• Ensures dissemination of LC-approved CCDS, USPI, EUPI and derived labeling documents and supporting documentation

• Ensures quality of labeling deliverables (e.g., alignment of labeling text with data, regulatory requirements, consistency (where appropriate) between labeling documents)

• Contributes to the continuous improvement of the end to end labeling process

• Contributes to and implements the global labeling strategy including the development of target labeling

Director level: may lead the development of target labeling to inform late stage drug development and to facilitate discussions with EU and US Health Authorities

Required Leadership Competencies:

• Integrity And Credo-Based Actions required (lives Credo values; builds trust; tells the truth; initiates transparency into problems; demonstrates genuine caring for p

• Collaboration and Teaming required (puts interests of enterprise above own; works well across functions and groups; builds teams effectively; inspires followership; instills a global mindset; champions best practices)

• Results and Performance Driven required (assumes personal ownership and accountability for business results and solutions; consistently delivers results that meet or exceed expectations; makes the customer central to all thinking; keeps the focus on driving customer value)

• Self-Awareness And Adaptability required (resilient; has personal modesty and humility; willing to learn from others; patient, optimistic, flexible and adaptable)

• Sense of Urgency required (proactively senses and responds to problems and opportunities; works to reduce “cycle” time; takes action when needed)

• Big Picture Orientation With Attention To Detail highly desired (able to operate in two “worlds” simultaneously e.g., growth and cost control, enterprise and operating company success; sees the why as well as the what; can zoom in or out as needed)

• Director level: Strategic Thinking required (driven to envision a better future; takes any role or job and makes it better; has relentless dissatisfaction with status quo; motivated to leave things better than they were; a change agent)

Technical Competencies & Knowledge: 

• Labeling expertise with in-depth knowledge of labeling regulations globally (EU, US and International (e.g., Council for International Organizations of Medical Sciences (CIOMS)) highly desired

• Therapeutic area and product knowledge and expertise, and understanding of drug development process highly desired

• Strategic understanding of labeling including implications of data on primary labeling documents and derived labeling documents through to the artwork and packaging components; in depth understanding of what data would be required to support a labeling statement and the most appropriate placement of specific text within the labeling; understanding of relationship between labeling and product commercialization highly desired

• Ability to use labeling business systems (including labeling document management system and other tools used in support of labeling compliance) required

• Demonstrated ability to lead in a matrix environment required

• Director level: ability to drive the creation of target labeling for a compound, in line with the Global Labeling Strategy and Global Regulatory Strategy

DECISION-MAKING AND PROBLEM-SOLVING: Describe the types of decisions which are made, reviewed or referred. Describe the types of problems solved or referred. Indicate the degree to which decisions made and problems solved are circumscribed by procedure, policies, standards, or regulations. (TYPE BELOW THIS LINE)

Has oversight and responsibility for the development, revision, review, approval and maintenance of primary and derived labeling documents for the assigned compounds.

Coordinates the resolution of any labeling issues with potential impact on the primary or derived labeling, or the supporting documentation.

Director level: independently leads the escalation of labeling documents and decisions to the Labeling Committee; independently guides teams to resolve complex issues or issues that require higher level management involvement.

Director level: has responsibility for the most complex compounds within the therapeutic area, i.e. new chemical entities, first-in-class compounds and/or acceleration compounds/programs, which are either developed globally or for which there is a collaboration with an external partner.

INDEPENDENCE/AUTONOMY: Describe level of supervisory/managerial oversight.

This role works under the supervision of the Global Labeling Therapeutic Area Head (GLTAH). Managers and Associate Directors will manage/lead with limited supervision. Directors work independently and can independently lead the Labeling Working Group, implement the labeling strategy for their teams and resolve complex issues for their compounds.

REPORTING RELATIONSHIPS: Describe where this position fits in relation to the rest of the department it resides.

Reports into the Global Labeling Therapeutic Area Head.

RESPONSIBILITY FOR OTHERS (If applicable): Describe the nature of supervision exercised over others by this position.

Not applicable.

WORKING RELATIONSHIPS/INTERFACES: Describe the primary working relationships (internal & external) and primary interfaces along with the frequency and purpose/nature.

 Interacts with the GRA Global Regulatory Leaders, North America Liaisons, Regional Regulatory Representatives and Local Regulatory Representatives to implement the global labeling strategy within the scope of the global regulatory strategy, including the development, review and revision of labels globally, and to address comments from health authorities. Works also with the GRT in this respect.

 Interacts with other GRA, R&D and commercial functions in the scope of the Labeling Working Group to ensure optimal labeling content.

 Director level: Interacts at higher levels of the organization in support of their compounds, in particular with regard to issue escalation and resolution at the level of the Labeling Working Group and the Labeling Committee.

 Director level: Mentors and coaches junior members of the department.

KNOWLEDGE, EDUCATION, EXPERIENCE, COMMUNICATION SKILL REQUIREMENTS: Describe the minimum knowledge, education, prior work experience, communication skill requirements for the position. Include any degrees, certifications, language, or computer skills which are required and/or desirable.

• Minimum of Bachelors degree in a scientific discipline or equivalent required 

• Advanced degree (MS, PhD, MD or PharmD) highly desired with equivalent experience

• Manager: 8+ years of experience required (5+ years of pharmaceutical industry or health authority experience); at least 4 year of Regulatory Affairs with experience associated with product labeling/labeling regulations highly desired

Associate Director: 8+ years of experience required (7+ years of pharmaceutical industry or health authority experience); at least 4 years of Regulatory Affairs with experience associated with product labeling/labeling regulations highly desired

Director: 10+ years of experience required (7+ years of pharmaceutical industry or health authority experience); at least 6 years of Regulatory Affairs with experience associated with product labeling/labeling regulations highly desired

• Manager: minimum 1 year of experience within a supervisory capacity or leading teams within a matrix environment desired

Associate Director: Minimum 2 years of experience within a supervisory capacity or leading teams within a matrix environment desired

• Understanding of competitors in the therapeutic area and what they are doing in early/late development and knowledge of labeling aspects highly desired

• Solid understanding of biology and pharmacology relevant to therapeutic area highly desired

• An understanding of product development required

• Demonstrated proactive approach and focus on continuous improvement highly desired

• Exceptional verbal and written communication, negotiation and partnering skills highly desired

• Demonstrated ability to drive collaborative, customer focused, learning culture highly desired

Warm Regards,

Sneha Shrivastava

Clinical Recruiter

Integrated Resources, Inc

IT REHAB CLINICAL NURSING

Tel: (732) 549 5307

Fax: (732) 549 5549

Inc. 5000 - 2007, 2008, 2009, 2010, 2011, 2012,2013 & 2014 (8th Year)

Certified MBE I GSA - Schedule 66 I GSA - Schedule 621I I GSA - Schedule 70