Regulatory Country Strategist at Pfizer

Job ID: 1050528
Full-Time: Regular

Position Purpose

• To manage projects and product-related registration strategies in the assigned countries.
• Single point of contact for WSR-EM and PCO team on regional issues
• To ensure that regulatory documentation meet relevant regulatory requirements.
• To apply knowledge and interpretation of regulatory requirements in the assigned countries to the drug development process, including promulgation of health authority marketing authorization dossiers to enable efficient and effective registration of medicinal products consistent with the supported regions commercial objectives.
• To ensure business continuity between headquarter Product Strategists and Regulatory PCO staff.
• To build local relationships and ensure communication/clarity of regulatory timelines and strategy

Primary Responsibilities
Resources Managed:

• Supervise Contractors /FTE for assigned Projects.

Regulatory:

• Apply regulatory expertise for assigned therapeutic categories/countries to enable preparation of high quality documentation and assure compliance with departmental procedures.
• Provide input to the WSR-EM regulatory strategy for the development of products in-line with business objectives, ensuring strategies are adequately reflected in relevant country plans (e.g., business development or manufacturing supply) and alignment is achieved between regulatory activities and relevant country business/commercial plans.
• Liaise with GCMC, WSR, PGS, Submissions Management, PCOs, ILG, ALIM, Cluster/Market, and any other key stakeholders to ensure the filing strategies are defined and executed and BoH requirements are met, ensuring a submission ready dossier.
• Ensure that the appropriate regulatory requirements systems and database are updated in a timely manner when changes occur in market regulations. Ensure a submission planning and forecasting tool is utilized to update timelines.
• Support all product lifecycle regulatory work, and liaise with GCMC, Submissions Management, Cluster/Market, and any other key stakeholders.
• Manage regulatory strategies and plans for assigned countries, including review of existing regulatory guidelines and relevant literature.
• Provide input to the local/regional Pfizer commercial strategic planning process as appropriate.
• Co-ordinate with Product Strategist the receipt, distribution and response to regulatory queries from target countries, in line with product role in ISR, consistent with departmental procedures and including liaison with RRT members to ensure that response targets are met.
• Manage customization and dispatch dossiers to PCOs.
• Develop detailed understanding of regulatory guidelines and technical requirements in assigned countries and ensure that WSR-EM is aware of regulatory requirements (e.g., department presentations and Regulatory Requirements database) and assist WSR EM Policy with assessing the regulatory environment and identifying relevant trends.
• Regularly follow up with PCOs on progress of registration submission and approval activities, and ensure line management are advised of progress in regulatory filings.

Project Management:

• Oversee and/or facilitate training of Hub activity, including improvements to WSR EM departmental processes and procedures, RRS curriculum, WSR systems and databases, and applicable Pfizer policies and procedures.
• Ensure product strategies, submission and approval time lines, and country registration requirements/guidelines are accurately captured and current in applicable systems/regulatory databases.
• Ensure notifications of proposed regulatory changes and approvals are communicated to relevant stakeholders in a timely manner.
• Participate and/or lead cross-functional project teams, to address business needs in line with WSR EM business units, Medical Departments, and County business objectives.
• Represent their countries at relevant regulatory and project teams, or interdivisional meetings, as appropriate
• Ensure that comprehensive records of communications, country requirements and regulatory status, are maintained.
• To regularly follow up progress on regulatory submissions with PCO countries.
• Contributes to the development of filing and approval goals for the region.
• Ensure systems are in place and adhered to, to optimize process efficiency with out-sourced and in-house contractors, where applicable.

Technical Skill Requirements
Competency 1.1.2. Detail / Comments (specific skills, etc.):

• 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.
• Technical skill Technically competent to understand CMC submissions, interpret and communicate BoH requirements, and identify potential regulatory risks.
• 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.
• 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 team 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.

Qualifications
Preferred education, experience, attributes:

• Scientific Degree. A higher Degree (Pharmacy, B.Sc) may be an advantage but is not essential.
• Appropriate Regulatory Experience - minimum 3-5 years experience
• Proven ability to manage complex regulatory or drug development issues.
• Proven ability to consistently deliver to time, cost and quality standards.
• Fluent in English - written and spoken communication skills
• Attitude: Right mindset, Outward looking, Strategically minded, Project management skills preferred
• History of delivery - country and/or regional
• Country/regional knowledge (specifically, MER, NEAR, South Africa, Maghreb).