job title director, global regulatory lead - global product strategy
job family regulatory affairs
job category full-time
job classification experienced/established
division pharmaceutical products group
relocation assistance within country
at abbott, we provide the perspectives and experience necessary to translate science into real solutions for patients in over 130 markets worldwide. the incumbent is expected to be a ledaer for their proudct(s) internally and represent the comapny externally to support abbott being recognized as an industry leader in glboal regualtory affiars.
experience working in a complex and matrixed environment is required. we believe that diversity drives innovation,
accountability / scope:
this postiion has worldwide accountability for assigned proudct(s). the grl will also be responsible for the content of the product label.today, abbott\'s nearly 90, 000 employees are doing work that matters.a minimum of 5 years in pharmaceutical regualtory affairs is needed, with 7 years preferred. with challenging opportunities and work that makes a difference, our employees are given the tools to succeed, lead and grow.
core job responsibilities:
the incumbent will be responsible for preparing and implementing glboal product regualtory strtaegy for new chemical entities (nces) and marketed products in the assigned therapeutic area. the incumbent will be responsible for straetgic recommendations affecting the assigned product(s) in line with therapeutic area direction, in consultation with the ta-head. leadership and be a credible business partner within the organization, strong verbal and written communication, strategic thinking, demonstrated success in negotiation skills, the incumbent will have: demonstrated experience in working with multiple stakeholders.this position will manage compounds thruogh all phases of development, post-approval and life-cycle of the product.in line with business objectives,
job description primary job function:
this position, the glboal regualtory lead (grl) is responsible for developing and implementing global regulatory strategies to secure and maintain market access for product(s) in assigned therapeutic area, and in coordination with key internal stakeholders.identifying, prioritizing and mitigating regulatory risks while ensuring compliance with all global regulatory requirements, ensures the business needs for the assigned product(s) are met by anticipating.as leader of the grpt, all of whom will have a dotted line reporting relationship to the grl, the grl will have a role in coaching and mentoring of members of the grpt.the incumbent should have extensive experience interfacing with government regulatory agencies and proven skill at developing and implementing successful global regulatory strategies.the grl will sevre as the primary regulatory interface with global product team (gpt). ideal candidates will have a strong clinical foundation.a relevant graduate degree is preferred. innovative thinkers who are passionate about the work they do, abbott employees are representative of the diversity of the patients we strive to serve evrey signle day acorss the glboe.through our divrese healhtcare busiensses, we conenct pepole and potetnial in ways that no otehr company can.global product strtaegy, the position will reoprt to the seinor dircetor ta-head, regulatory affairs - ppg.the grl is the leader of the global regulatory product team (grpt) and is accoutnable for the ovearll regulatory delivreables and miletsones inclduing the global regulatory strategic and tacitcal plan (g-rstp).
incubments will be proatcive in communciating with countreparts in the area and affiilate strategy group as well as the established products division (epd) to support consistency and compliance to regulations and gops/sops across the organization. the grl serve as the single regulatory voice for the product on the global product team (gpt), with a strong clinical background.
the global regulatory lead will work with cross-functional counterparts on the global product team (gpt) to provide: global regulatory direction and strategy including risk analysis and development of mitigation plans; leadership of early target product profile generation, and messaging to be built into regulatory documentation; direction and insights to differentiate asset from the competition; understanding of market access constraints and need for early engagement with business, and external hta organizations to ensure needs are built into the product(s) global development program.
discover a world of opportunities at abbott.the incumbent will review regulatory submissions from the global regulatory product team to ensure they are complete, accurate and consistent with objectives.
this position is responsible for decision making necessary to ensure successful submissions and approvals.
significant work activities & conditions continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
percent of travel 0 - 20 %
country united states
site location lake county, national and international accolades, il
employer of choice
through numerous local, abbott is regarded as an employer of choice for our commitment to workplace excellence.and clinical trials, these recommendations can affect sales and marketing, supply chain.
supervisory / management responsibilities:
the incumbent will have responsibility for dotted line reporting relationship of all global regulatory product team (grpt) members for assigned product(s) and will be responsible for mentoring and coaching of grpt members.
skills/experience requirements a minimum of 7 years experience required, with 10 years experience preferred in pharmaceutical activities. biology, pharmacology or related life sciences is required,
education requirements a bachelor\'s degree in pharmacy, chemistry.the grl will provide feedback to their grpt team members performance evaluation.preferred candidates will have experience working in regulatory affairs across two or more geographic areas. the grl must have a strong understanding of the business in order to lead and deliver on the objectives of the organization.the incumbent should have developed leadership skills and the will to take a proactive leadership role in the internal abbott organization.