Director, Regulatory Sciences

Pfizer Inc.; Marlow; On-site; GBP 90,000 - 120,000; Full time

Job summary

A global pharmaceutical leader is seeking a Regulatory Operations Director in Marlow, UK to oversee regulatory strategy and ensure compliance with regulations. The ideal candidate should possess a Bachelor's Degree, preferably a Master's or Ph.D., and have 10+ years of management experience in the pharmaceutical industry. Responsibilities include directing regulatory policy, managing product registrations, and collaborating with scientists. The company values diversity and offers reasonable adjustments for applicants.

Qualifications

• Minimum of 10+ years of management experience in the pharmaceutical and/or medical device industry.
• Significant management experience in Regulatory Affairs with proven global experience.
• Knowledge of EU regulations and global strategy related to pharmaceuticals.

Responsibilities

• Direct regulatory operations and strategy for efficient registration of marketed products.
• Ensure compliance with regulatory requirements and minimize business interruptions.
• Develop and implement strategies to influence regulations and guidelines.

Skills

Regulatory strategy

Negotiation skills

Leadership

Scientific evaluation

Communication

Education

Bachelor’s Degree

Master’s Degree

Ph.D.

Job description

Overview

Directs regulatory operations and strategy to assure efficient registration of changes to marketed products; sets regulatory policy to ensure ongoing compliance of marketed products; designs and implements processes in support of marketed product lifecycle management. Maintains products and procedures in regulatory compliance to minimize the probability of business interruptions. Provides leadership for regulatory professionals by collaboratively establishing development goals and plans for staff. Recruits and retains scientific managers (B.S., M.S., Ph.D., M.D.). Develops succession plans and competencies for the group.

Responsibilities

• Incorporates knowledge of current regulations, guidances and the legislative and competitive environment into regulatory decisions and strategy.
• Ensures that agreed regulatory strategies are efficiently implemented, and that strategies are maintained in-line with changing regulatory needs and business needs.
• Maintains a constructive regulatory risk (compliance) position that minimizes the probability of business interruptions and regulatory actions that have the potential to negatively impact relationships.
• Guides the assessment of scientific data required for registration purposes against global regulatory requirements and develops strategies for effective data presentation; negotiates with development teams to obtain the required data.
• Establishes with Business and Scientific Management a timetable for the registration of all product changes in line with business priorities, tracks and reports on progress through the agencies to assure success.
• Develops and implements internal and external strategies to proactively influence legislation/guidelines and to address changes in the regulatory environment.
• Sets hospital policy and assures standard interpretation of regulations in support of post‑approval change to marketed products.
• Leverages knowledge of current regulations, guidances and the legislative and competitive environment to provide regulatory support during Agency inspections.
• Responsible for a broad product range, each with its unique regulatory development needs and legislation.
• Develops effective regulatory strategies across a large number of international markets.
• Manages regulatory involvement throughout the life of product including regulatory compliance support during manufacturing and product improvements, site transfers and product/process remediation.
• Required to be innovative and creative in seeking solutions that comply with regulations but are also sound from business and technical perspectives.
• Makes recommendations to internal management and partner companies that accurately reflect the benefits and risks and provides contingencies and alternate approaches.
• Directly influences the development of product line extensions and improvements to existing products, which can increase sales and/or reduce compliance risk.
• Approves regulatory data packages prior to filing and during the approval process; identification of issues often impacts time to approval.
• Establishes and optimizes regulatory strategies to positively impact revenue.
• Negotiates data requirements with regulatory agencies, which can expedite approvals and minimize costs.
• Analyzes and interprets complex scientific data as well as global regulations.
• Assesses scientific data provided for registration purposes against regulatory requirements.
• Influences scientists to effectively present complex scientific data to meet the needs of individual regulatory agencies.
• Summarizes complex technical data and presents strategies and data to management and regulatory agencies.
• Critiques summarized engineering, clinical and statistical data and makes recommendations on data presentation and utility.
• Is the recognized authority on regulatory matters and requires little, if any, supervision dealing with internal management or with external agencies.
• Strategy and diplomacy skills required due to regulatory involvement in delicate relationships.
• Leads and leverages the division/corporate understanding of compliance and regulatory risk and provides direction and strategy.
• Manages external contacts, including global regulatory agencies, partnership companies, standards‑setting groups, and industry groups; works across boundaries to negotiate solutions with external agencies.

Qualifications

• Education: Bachelor’s Degree (required), Master’s Degree preferred, Ph.D. preferred, Other (R. Ph.) preferred.
• Degree in pharmacy, biology, chemistry, pharmacology, engineering, or related subject.
• Scientific training required to evaluate scientific data in registration documentation and effectively negotiate with internal and regulatory agency scientists.
• Minimum of 10+ years of management experience in the pharmaceutical and/or medical device industry.
• Significant management experience in Regulatory Affairs with proven global experience.
• Knowledge of key elements in the development and manufacturing process to facilitate regulatory report generation and issuance.
• Expertise in EU, labeling and CMC requirements and global strategy and legislation.
• Proficient in communicating strategic and tactical issues to management.
• Demonstrated understanding of business needs and proven leadership.
• Leverages personal networks; celebrates and rewards team success.

Equal Employment Opportunity

We believe that a diverse and inclusive workforce is crucial to building a successful business. Pfizer is an Equal Employment Opportunity employer and is committed to celebrating diversity in all its forms. We are a Disability Confident Employer and encourage you to put your best self forward. We will provide reasonable adjustments as necessary.