職位描述
職位描述：
Organizational Relationship(s) including to whom the position reports
? Reports to Regulatory Manager
? Works with WSR colleagues and relevant project team members (i.e. R&D, Medical, Safety, Project management, Risk management, Manufacturing, PGS, Commercial, Legal, and Quality), to develop & align on regulatory strategy
? Works directly or indirectly with external contacts in Regulatory agencies and Trade Associations
? Collaborates with WSR colleagues to align on regulatory strategy development and execution
Primary Responsibilities
Regulatory Assessment, Strategy & Implementation:
? Develops regulatory strategies, in a risk based approach, to optimize regulatory approval, timing, competitive positioning and global opportunities for new and existing products.
? Ensures regulatory contributions achieve the objectives of the strategy in line with agreed standards, maximizing overall project delivery time and probability of success. Facilitates filing activities for new applications and lifecycle management.
? Provides strategic expertise in cross functional project teams.
? Implements regulatory plans are monitored, progress/variance communicated to key internal/external stakeholders and any risks mitigation plans are prepared.
? Develops regulatory assessment, strategy and implementation activities and overall communication of risk mitigation plan and measures to business partners.
Regulatory Submissions:
? Coordinates, prepares and files new applications and lifecycle changes in line with business objectives and timing.
? Builds regulatory content by authoring or redacting core information for submission of components not delivered by other functional areas.
Artwork/Labeling/Promotional Activities:
? Ensures timely review/approval of labeling, artwork and promotional materials and adherence to commercial and regulatory standards.
? Interacts with appropriate cross-functional teams to shape label for assigned projects/products to ensure commercial needs and quality standards are met.
Business Partner Relationships and Collaboration:
? Supports key account activities by building effective partnerships within and outside of the company.
? Partners with project teams and other groups (BU, Global Regulatory, GCMC, R&D, Submission&Operation, Publishing, etc.) to ensure required regulatory contributions (label, submission content, license renewals, etc.) meet business needs, timing and qualified standards.
? Ensures an aligned regulatory position supporting the business is reached and communicated to all key stakeholders. Ensures that issues for assigned projects are communicated and escalated as applicable.
Regulatory Interaction & Influence:
? Develops and maintains constructive working relationships with the BOH.
? Proactively monitors, collects, builds and communicates regulatory and competitive intelligence for professional development purposes, business planning needs and alignment with global regulatory activities.
Regulatory Compliance:
? Provides impact assessment and mitigation measures of BOH regulatory and policy changes to new and existing products and ensures timely communication to WRS and all other impacted stakeholders.
? Conducts due diligence regulatory assessments for business development / acquisition products.
? Ensures business compliance (e.g., SOPs and company managed systems) and implementation of and adherence to BOH regulatory standards.
? Execute and monitors progress of CAPA as related to regulatory issues and ensuring objectives for registrations are aligned to Commercial priorities.
? Accountable for training compliance (P2L) of self and/or team.
People & Capability (People Managers):
? Ensures ongoing professional development through appropriate training.
? Participates in directing personnel growth, developing regulatory and technical knowledge through Performance demonstration, appropriate trainings in order to build sustainable regulatory competence.
Budget:
? Accountable for budget input and expense monitoring.
Technical Skill Requirements
Technical Competencies
Competency Detail/Comments (specific skills, etc.)
Scientific knowledge application and strategic mindset Capability to assess, analyze and summarize technical, chemistry and clinical data and synthesize this with external regulatory environment rends into workable regulatory strategies and issue mitigation options.
Understands pharmaceutical and consumer healthcare industry Understands and develops mitigation strategies for issues and drivers impacting the industry.
Knowledge of product development practice rules, regulations, guidelines and policies Familiarity with multiple factors likely to influence the regulatory environment, including new and emerging guidelines relevant to regulatory strategies and compliance.
Proven ability in development and implementing regulatory strategy Understanding of regulatory agency philosophy and guidelines. Experience preparing and filing a range of pre and post regulatory submissions. Working with and influencing regulators and opinion leaders, facilitating approval of submissions and labeling meeting corporate expectations.
Communication skills Ability to communicate complex information and analyses to a variety of scientific and non-scientific audiences in both verbal and written format.
Presentation skills Effective in a variety of formal presentation settings with peers and senior managers.
Knowledge of the Country regulatory environment and how this impacts regulatory strategy and implementation. Knowledge of philosophy of sub-regional countries regulatory environment. Understanding of regulatory agency philosophies and guidelines. Experience preparing and submitting NDA’s, variations and renewals. Working with and influencing, opinion leaders, external organizations and PCO’s facilitating approval of submissions.
Knowledge of drug development practice, rules, regulations and guidelines. Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines relevant to Regional regulatory strategies and implementation plans.
Understands Pharmaceutical and Consumer Healthcare Industry Understands and develops mitigation strategies for issues and drivers impacting the industry.
Communication skills at Country/Sub-regional level Communicates effectively using a variety of mediums appropriate to the setting.
Understanding of regulatory agency processes, philosophies approaches and guidelines in key countries
Experience preparing and submitting new applications and life-cycle management (variations, renewals, etc.) in key countries
Understanding of China consumer health environment especially in terms of advertising rules and pricing in key countries
Good relationships with local regulatory: BOH, Food Supplement authority and any other applicable bodies in the key countries
Ability to identify issues and challenges and works with partner groups to identify options and implement agreed solutions
Ability to understand and develop mitigation strategies for issues and drivers impacting the project
Good knowledge and handling of RA IT systems
Proven business management capability
Risk management principles and application
Effectively applies risk management and understanding of the application to regulatory risk and mitigation.
Technical Skill Requirements
Behavioral Competencies (Shaded are core Pfizer)
Competency Detail/Comments (specific skills, etc.)
Sizes Accountability Takes personal responsibility for own work, pushes self and others to exceed goals and deliver results
Grows Others People Managers: Makes developing others a managerial priority by crafting and managing compelling development plans.
Grows Self Takes accountability for own career development, regularly updating and acting on development plan
Change Agile Demonstrates perspective and poise in the face of uncertainty and effectively gets things done amidst organizational change.
Self-awareness Understands own strengths and limitations, and seeks and receives feedback in a non-defensive manner.
Commits to "One Pfizer" Models a personal alignment with Pfizer's mission and vision, and behaves consistent with culture and values
Peer relationships Establishes positive colleague relationships which further collaboration and cooperativeness.
Business Acumen Knows how a global corporation works; knowledgeable in policies, practices, trends and functions affecting Pfizer, the competitive dynamics of our industry, and how the marketplace is transforming.
Influencing Uses an information system of contacts to facilitate and share ideas of learning.
Understanding of Stakeholder needs Understanding internal and external needs to gain trust, settling differences and winning concessions without damaging relationships.
Team work Comfortable acting in a wide range of team roles in the wider project interest.
Adaptability Able to build effective working relationships and deliver results in a wide range of environments and cultures.
Problem solving Effectively identifies issues and challenges and works with partner groups to identify options and implement agreed solutions.
Qualifications (i.e., preferred education, experience, attributes)
? University Bachelor's Science degree. A higher degree may be an advantage but is not essential. Post-secondary Regulatory Affairs Certification an asset.
? Minimum 2-3 years of applied regulatory experience in the pharmaceutical / dietary supplement industry or equivalent workplace experience, with preferred OTC regulatory experience.
? Proven ability to manage multiple projects in a fast paced environment and exercise good judgment prioritizing tasks.
? Experience in communication with key regulatory authority as well as participating interactions is preferred.
? Experience in regulatory strategy development and submission preparation and filing (within at least one therapeutic area throughout the product lifecycle, preferred).
? Computer literate in MS word, PowerPoint, Outlook, Excel, Adobe and familiarity with database navigation and usage.
? Regulatory Experience with Consumer products required; additional experience in Rx Regulatory Affairs may be advantageous.
? Proven ability to quick learn and manage complex regulatory issues.
? Broad R&D experience in medical or technical areas preferred.
? Proven ability to consistently deliver to time, cost and quality standards.
? Country regulatory experience including knowledge of and application submission processes and product life cycle management activities for various consumer product categories.
? General management experience with line management and leadership at senior management level is essential.
? Demonstrable experience of effective delivery of objectives in a complex matrix environment.
