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Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.
JOB SUMMARY
The PCO based Regulatory Senior Associate will support the development of the strategic direction and work closely with Country based PCO teams and above country regulatory teams to develop and execute regulatory strategies and plans for the country.
The PCO based Regulatory Senior associate supports and reports to the Senior Regulatory Manager.
JOB RESPONSIBILITIES
• Support the local PCO team in the development of regulatory strategies to support the registration of clinical trial applications, new products, line extensions, major variations and lifecycle management. Provide strategic regulatory input into WRS global regulatory strategies, thus providing optimal support for meeting local business objectives under Country Regulatory Head lead.
• Develop strong partnerships with in-country (e.g. BU leads, Market Access, Marketing, Supply Chain) and with above country (e.g. Country Strategists, GCMC Hub, Submission and labeling/artwork Hubs, WRS-EM Therapeutic Area and Regional Teams) to facilitate the development and implementation of registration strategies to expedite the registration of new products, line extensions and life-cycle optimization.
• Responsible for their own personal development, leadership and performance to achieve company objectives and agree training and development needs with Country Regulatory Heads to develop and enhance individual capabilities and capacities
• Responsible for developing and enhancing relationships with key external agencies (HA’s/BoH, RKOL’s, etc.). Manage the HA/BoH interface throughout the development and lifecycle of a product.
• Active participation in local trade organization and effective communication to key stakeholders of key issues that could impact regulatory strategies or the business. Understand local regulations and
• developing trends in the local regulatory environment and provide assessment of the impact to key stakeholders. Leverage regulatory intelligence / landscape knowledge to support the development and implementation of regulatory and business strategies.
• Maintain licenses (e.g. Marketing Authorizations) in compliance with local regulations by ensuring that corporate regulatory processes, SOP’s and systems are followed ensuring training in P2L are completed 100% (systems and procedures).
• Maintain compliance (GDMS, GRS, AT, RRBD, RRS, CMC change control, product labelling, etc.) at 100%.
• Where needed, oversee and manage the completion of CTA, NDA and Lifecycle (LC) submissions and approvals as per established WRS-EM performance metrics.
QUALIFICATIONS / SKILLS
• Knowledge of the Regional and Global regulatory environment and how this impacts regulatory strategy and implementation
• Understanding of regulatory agency philosophies, culture, and developing trends in the regulatory environment. Experience in preparing and submitting CTA’s, NDA’s, variations and LC submissions. Working with and influencing, opinion leaders, external organizations and PCO’s facilitating approval of submissions. Is driven to continually enhance regulatory expertise, both locally and globally.
• 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. Maintains internal and external networks to learn in advance about new regulatory trends or changes impacting the Regulatory, Medical and overall Business strategy.
• Strategic Thinker
• Provides strategic contribution and anticipates what RA needs to contribute to develop and achieve business objectives. Effectively explores alternative regulatory strategies and positions to reach outcomes that gain the support and acceptance of all parties.
• Communication skills
• Clearly conveys information and ideas through a variety of media to individuals or groups in a manner that engages the audience and helps them understand the message.
• Negotiation skills
Can negotiate skillfully in tough situations with both internal and external groups. Can be direct and forceful as well as diplomatic. Gains trust quickly of other parties to the negotiations. Has built a strong relationship with the local health agency and other relevant stakeholders (rKOL’s) and pro-actively manages issues with the HA’s and other key external stakeholders.
• Problem Solving
Effectively identifies issues and challenges and works with partner groups to identify options and implement agreed upon solutions.
• Detailed Orientated
Can be thorough and complete with high quality.
• Project Management
Can manage complex and multiple projects
Education:
• Scientific Degree. A higher degree (Pharmacy, BSc) may be an advantage but is not essential.
• Appropriate Regulatory Experience minimum 2-3 years +Industry experience
Experience:
• Demonstrable experience across the Drug, Discovery, Development and commercialization lifecycle, with proven examples of contribution.
• Proven ability to manage complex regulatory issues.
• Proven ability to consistently deliver to time, cost and quality standards.
Regional/Country regulatory experience including submission processes and product life cycle management activities.
Attributes:
Understanding stakeholder needs
Understanding internal and external stakeholder needs to gain trust, settling differences and winning concessions without damaging relationships
Network and alliance building/ peer relationships
Uses an informal system of external and internal contacts to facilitate and share ideas and learning. Establishes and maintains a wide range of relationships to support, guide and enable improved personal and organizational performance. Can quickly find common ground and solve problems for the good of all. Is seen as a team player and is cooperative.
Influencing
Uses a range of communication styles and choosing appropriate strategies to deliver goals against a backdrop of diverse agendas, priorities and cultures.
Team working
Comfortable acting in a wide range of team roles in the wider project interest
Interpersonal acumen
Relates well to all levels of people inside and outside the organization. Build constructive and effective relationships, uses diplomacy and tact and can diffuse high-tension situations comfortably.
Perspective
Looks toward the broadest possible view of issues/challenges and is able to project impacts to the future
Strong quality and compliance orientation
Has an understanding of regulatory compliance issues and the potential impact of compliance related issues on meeting business objectives.
Analytical Thinking
Can analyze large quantities of complex scientific data and synthesize this with external regulatory environmental trends into workable regulatory strategies and issue mitigation.
Adaptability
Able to build effective working relationships and deliver results in wide range of environments and cultures.
ORGANIZATIONAL RELATIONSHIPS
• Distributors
• Labelling team
• ALIM
• GCMC
• Supply
• Commercial team
• Direct Report to Regulatory Head of Cluster
• Works closely with local CRL BU teams in country and other stakeholders
• Builds relationships with local Health Authorities.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Regulatory Affairs