Director, Global Regulatory Affairs

Directs regulatory strategy to assure efficient registration of new products and changes to marketed products to support the Hospital Business Unit's Sterile Injectable development portfolio; sets Hospira regulatory policy to ensure ongoing compliance of products through the initial registration process and marketed products; designs and implements processes in support of efficient regulatory work flow. Directs US submission strategy to ensure efficient and timely health authority approval. 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

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 primarily in the development phase (pre-submission & pre-approval), but may also support regulatory activities 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 company's image, customer confidence and company performance in terms of earnings 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.

Preferred Education:

• Bachelor's Degree - Required plus 14 years experience
• Master's Degree - Preferred plus 12 years experience
• Ph. D - Preferred plus 9 years experience
• 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.
• Management experience in Regulatory Affairs greater than five years, at least two to three years global experience.
• Understands the key elements in the development and manufacturing process to facilitate regulatory report generation and issuance.
• Understands global strategy and legislation.
• 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.

Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

PHYSICAL/MENTAL REQUIREMENTS

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Up to 10% Travel

Other Job Details:

Last Date to Apply for Job:12/08/21
Additional Location Information:United States - Illinois - Lake Forest
NO Relocation Package
Eligible for Employee Referral Bonus

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Regulatory Affairs

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