Director, Regulatory Sciences

JOB SUMMARY

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.

JOB 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 with regulatory and the public.

• 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 Hospira 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.

QUALIFICATIONS / SKILLS

Problem Solving:

• 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 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 to find solutions that comply with regulations but are also sound from business and technical perspectives as well.

• Makes recommendations to internal management and at partner companies that accurately reflect the benefits and risks and provides contingencies and alternate approaches.

Accountability:

• 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. Regulatory and compliance problems are openly publicized and can negatively impact the companys image customer confidence and company performance in terms ofearnings and stock price.

• Establishes and optimizes regulatory strategies to positively impact revenue. A successful regulatory strategy can have a critical impact on eventual revenue by early approval with the best possible label.

• Negotiates data requirements with regulatory agencies which can expedite approvals and minimize costs.

Analytical Ability:

• 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.

• Data analysis and critical thinking skills are essential to critique summarized engineering clinical and statistical data and make recommendations on data presentation and utility.

Authority to Act:

• Is the recognized authority on regulatory matters and requires little if any supervision dealing with internal management or with external agencies. Appropriate upper management consultation may be sought when policy decisions are involved having a major impact to the corporation.

• Strategy and diplomacy are required because of regulatory involvement in delicate relationships where careful negotiations and managerial persuasion are critical.

• 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 these external agencies.

REQUIRED SKILLS AND EXPERIENCE

• Bachelors Degree

• Masters Degree Preferred

• Ph. D - Preferred

• Other (R. Ph.) - Preferred

• Degree in pharmacy biology chemistry pharmacology engineering or related subject.

• Scientific training is required to evaluate scientific data in registration documentation and effectively negotiate with internal and regulatory agency scientists.

Experience:

• Management position(s) in the pharmaceutical and/or medical device industry greater than ten years.

• Significant management experience in Regulatory Affairs including proven global experience.

• Understands the key elements in the development and manufacturing process to facilitate regulatory report generation and issuance.

• Understands global strategy and legislation with expertise in EU labelling and CMC requirements.

• Highly proficient in communicating strategic and tactical issues to management.

• Proven understanding of business needs

• Demonstrated leader.

• Leverages personal networks.

• Celebrates and rewards team success.

Purpose

Breakthroughs that change patients lives... At Pfizer we are apatient centric company guided by our four values: courage joy equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.

Digital Transformation Strategy

One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

Flexibility

We aim to create a trusting flexible workplace culture which encourages employees to achieve work life harmony attracts talent and enables everyone to be their best working start the conversation!

Equal Employment Opportunity

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer Pfizer iscommitted to celebratingthisin all itsforms allowing for us to be as diverse as the patients and communities we serve. Together we continue to build a culture that encourages supports and empowers our employees.

DisAbility Confident

We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people especially those with unique superpowers. Your journey with Pfizer starts here!