BioSpace · 6 hours ago
Associate Director, Global Regulatory Affairs Labeling Compliance
United States
Full-time
Remote
Director/Executive
8+ years exp
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Responsibilities
The Associate Director, GRA Labeling Compliance, is responsible for the strategic and operational activities pertaining to global and local labeling compliance and quality within Global Regulatory Affairs.
Partners with internal stakeholders and external CRO partners such as Global Regulatory Compliance, Global Labeling, IT, Global Regulatory Operations, GPSE (safety), Regulatory Therapeutic Areas, Local Operating Companies and Supply Chain on all matters related to global labeling compliance and quality.
With the Director of Global Labeling Compliance, is responsible for successful labeling compliance and quality management, end-to-end tracking of global labeling updates, and implementation of Global Labeling processes.
As a member of a growing Global Labeling Compliance organization, is involved in setting the direction for the team within Takeda, identifying and attracting the best talent to the organization, and strategizing the future of the organization with the Director of Labeling Compliance and others.
Collaborates with Global Labeling leadership to ensure clear and timely communication about labeling compliance activities and metrics.
Responsible for alignment with global strategic initiatives related to labeling events and the processes and systems used to manage labeling compliance.
Development and leadership of the following activities at a global level in collaboration with Head of GRA Labeling Compliance:
Responsible for labeling compliance-relevant strategic initiative activities which may impact labeling compliance and labeling processes (labeling event management systems, RIM systems, and quality documents).
With Global Labeling Operations, develop new and updated processes for labeling and labeling compliance, as required.
Ensure Takeda is aligned and responsive to external guidelines and regulations as they pertain to applicable regulatory requirements, i.e., oversight of creation of PSMF Annex F tables 1 and 2.
Provide Global Labeling Compliance support for internal and external audits:
Ensures inspection readiness
Coordinates Global labeling documentation requests prior to, during and in follow up to inspections/audits
Provide support to Global Labeling SMEs on presentations related to global labeling processes for inspections and audits
Presents on global and regional labeling processes and quality to inspectors and auditors
Supports the development of responses and CAPAs related to global labeling for audits/inspections
Provides regulatory and technical expertise to manage the regulatory inspection preparation and execution processes, including development of related tools and best practices
Guide activities to provide a state of readiness for Health Authority inspections within Global Labeling and supporting local country (LOC) activities, including the development of strategic internal audit plans, and the execution of internal audits
Ensures Labeling Commitments to partners and third parties are documented and tracked in the appropriate repository
Escalate issues/problems to senior management as needed
Provides input on budgets for the group as appropriate.
Maintains strong knowledge of current regulations, legislation, best practices, and guidelines relating to Regulatory Affairs and labeling
Represents Takeda at relevant Industry Forums e.g., LabelNet
Qualification
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Required
Bachelor’s degree (or equivalent) required. Masters preferred.
8 plus years in pharmaceutical industry, with good exposure to Regulatory Affairs, labeling, quality assurance, and/or compliance.
Familiarity with inspections and audit procedures
Strong knowledge of business area and interactions with strong regulatory environment and ability to identify and proactively manage the interactions necessary for achieving business goals and objectives
Ability to identify proactively and anticipate risk of non-compliance in a complex environment
Demonstrated knowledge of global health authorities, regulations, product approval, labeling, and lifecycle processes for major markets and of pharmaceutical and regulatory affairs requirements and practices
Practical operational experience of working across disciplines and across multiple regions. Experience working within a global team framework and a multi-cultural environment.
Able to manage both time and priority constraints and to manage multiple priorities simultaneously
Capability to critically analyze complex and/or ambiguous information and the impact on products and process and to effectively communicate complex issues both verbally and in writing.
Excellent analytical, technical, and problem-solving skills
Efficiently/actively manages conflict in a tactful, diplomatic way, seeking effective solutions for all parties.
Personnel management experience.
Project Management abilities
Preferred
Masters preferred.
TQM or Six Sigma experience preferred.
Systems Knowledge – extensive knowledge of Quality Management Systems, including eDMS, and Deviation (Trackwise) systems
Regulatory Familiarity – extensive knowledge of European, US and international regulations relative to labeling
Industry Knowledge – strong understanding of the pharmaceutical industry and pharmaceutical companies’ operations processes and strategies including Regulatory Affairs processes.
Analytical Skills – ability to identify the critical issues of problems or opportunities using appropriate information; determines the causes and possible solutions to the problem.
Communication – ability to express oneself clearly and concisely to a variety of audiences. Ability to understand/analyze/synthesize and communicate to internal/external stakeholders.
Teamwork - Ability to work with team members in a friendly, professional manner. Motivate and empower others. Manage teams to work productively in a high-pressure environment
Knowledge Sharing – ability to capture knowledge within (and from outside) the organization; offer solutions, improve processes and deliverables through use of information; improves information capital by contributing experience, deliverables, and models for others to use.
Interpersonal Flexibility – ability to adapt to other personalities in a respectful manner that is conducive to goal achievement.
Must be able to lead cross-functional and cross-regional teams and deliver results in a matrix organization. Excellent organizational skills and ability to prioritize.
Company
BioSpace
BioSpace is the leading online community for industry news and careers for life science professionals.
11-50 employees
H1B Sponsorship
BioSpace has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (2)
Funding
Current Stage
Growth StageTotal Funding
$10M2000-08-24Series B· $10M
Leadership Team
J
Joshua Goodwin
CEO and President
K
Kristin Jones
Chief Revenue Officer
Recent News
Crunchbase News
2024-11-20
2024-05-31
Company data provided by crunchbase
