Job: Director / Senior Director, Regulatory Policy and Intelligence

Jobing Description

Job DescriptionThis position is located in Rockville, MD.

Primary Functions
Manage and lead regional regulatory intelligence function
Prepare and present complex written and oral reports to Senior Management and external audiences
Propose sound regulatory policies influencing the regulatory environment in one or more geographic regions
Direct staff to identify and influence policies that impact Abbott.
Effectively use negotiation skills to resolve policy issues when unable to agree internally.
Anticipate consequences
Serve as primary regulatory liaison to trade association for management
Actively represent Abbott at trade associations
Advocate Abbott position by leading effort
Support Global Product Teams (GPTs) in specified therapeutic areas
Conduct external outreach with regulators, peers, and trades

Major Responsibilities

Define and implement regulatory policy initiatives
Distribute proposed policies to subject matter experts (SMEs)
Evaluate impact for Abbott
Lead formation of corporate position and share with trade associations
Consult with SMEs and coordinate internal review
Support supervisor and Senior Management discussion of policies at trade association meetings
Attend external meetings for specified policy topics and summarize for internal distribution.
Serve as strategic partner to Regulatory Affairs-Pharmaceutical Products Group (RA-PPG)
Contribute to regulatory/GPT strategy by responding to information requests and offering alternative views based on regulatory requirements and prior regulatory experience
Prepare for, attend, and debrief from FDA meetings
Create and respond to opportunities to enhance Abbott s relationship by organizing, speaking at, and participating in policy related meetings
Utilize local network of pharmaceutical companies to obtain policy-related information
Mentor junior staff

Position will be Director or Senior Director based on level of experience. Skills/Experience Requirements Basic Requirements:
Minimum 7 years experience in a regulated industry (e.g. pharmaceutical, medical products, nutritionals) required. Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.

Preferred Requirements:
10 15 years regulatory affairs experience and regulatory policy and intelligence experience preferred.
Education Requirements Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.
Significant Work Activities & Conditions Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Keyboard use (greater or equal to 50% of the workday)
Percent of Travel 0 - 20 %
Country USA
State/Province District of Columbia
Site Location Washington, DC
Employer of Choice

Through numerous local, national and international accolades, Abbott is regarded as an employer of choice for our commitment to workplace excellence. Our employees are given the tools to succeed, lead and grow, with challenging opportunities and work that makes a difference. Through our diverse healthcare businesses, we connect people and potential in ways that no other company can.

Discover a world of opportunities at Abbott.

EEO Statement:

At Abbott, we believe that diversity drives innovation. Innovative thinkers who are passionate about the work they do, Abbott employees are representative of the diversity of the patients we strive to serve every single day across the globe.