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Director, Regulatory Affairs Rare Disease
Job Opportunity at
Clinical Dynamix, Inc.
Posted on Mar 11
Global Pharmaceutical company with high profile trials is expanding and looking for a Director, Regulatory Affairs for their Global Management Team
Competitive base salary and bonus, full relocation and benefits, Long Term Incentives and more
Position IDEALLY is located in the Cambridge, MA office (there is small possibility the role can be based in their NJ office)
The Rare Disease Global Regulatory Team Lead (GRTL) is part of the Global Regulatory Affairs (GRA) team based in the US. He/she is responsible for developing long and short-term regulatory strategies that impact company’s business objectives.
Specific responsibilities include:
Global Regulatory Team Lead (GRTL) is responsible for developing global regulatory strategy for projects in his/her remit, which include both pipeline and life cycle management programs. In this capacity, the GRTL leads the Global Regulatory Team (GRT, consisting of Regions, Regulatory CMC, Regulatory Operations, Labeling) to develop robust regulatory strategies leading to first cycle approvals with optimal labels.
Represents Global Regulatory Affairs (GRA) as a member of the cross functional Global Project Team (GPT) and provides regulatory input for the project(s) globally. In this capacity, the GRTL is the single point of contact for the business and R&D on regulatory issues for the project. The GRTL leads the Global Regulatory Team (GRT), and may ask members of the Global Regulatory Team to participate in cross function project team meetings on an agenda driven basis.
The GRTL will ensure development of robust regulatory strategies for the program and will be accountable for developing and maintaining a regulatory strategy document. The regulatory strategy document will evolve over the course of a project’s development, but should include the overall regulatory strategy and how it will deliver on the Target Product Profile (TPP), regional specific needs, regulatory environment, regulatory risks and mitigations, global submission strategies, and reimbursement strategies. The GRTL will work with the GRT to ensure that relevant input from all GRA functions is vetted and included in the regulatory strategy.
The GRTL is accountable for ensuring that all GRA peer reviews are conducted in a timely manner ahead of key governance meetings and major (issue driven) ad hoc reviews by Sr. Management. The GRTL is also accountable for ensuring that GRA Sr. Management is aware of any major issues with the project, including any changes to risks.
The GRTL represents regulatory position at the internal governance meetings with senior leadership.
The GRTL will work with the labeling strategists and regional groups to ensure appropriate labeling content based on the clinical program and TPP. The GRTL will also work with the labeling strategist and regions to develop region specific labels.
The GRTL, working with the regions, will also interact directly with HAs as needed for the project.
The GRTL will work transversally to ensure a well-functioning GRT and nurture an environment where all GRA team members and functions have a voice.
Assess the accuracy and appropriateness of submissions to regulatory authorities to support successful clinical trial applications and/or marketing authorizations.
Provide regulatory due diligence assessments of new business opportunities as required
Depending on the program assignment, the GRTL may also serve as the US Regulatory Lead and responsible for developing and implementing the US regulatory strategy. The US lead will serve as the primary FDA contact as needed and will represent the US regulatory position to senior management governance committees as needed.
7 years pharmaceutical industry experience in R&D, Regulatory or related functions, with at least 5 years working in regulatory affairs (regionally or globally). Experience in other relevant functions will be considered.
BS in a scientific discipline.
Advanced degree is preferred (MS/PhD/PharmD).
Experience with least one major marketing application (NDA/BLA/MAA/JNDA etc…), or extensive experience with late stage development/marketed products.
Knowledge, Skills and Other Experience
Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy and guidance
Direct interaction/negotiation with regulatory authorities (e.g. FDA, EMA)
Strong strategic skills including the ability to make complex decisions and willingness to defend difficult positions.
Excellent operational skills including planning, organizing and ability to motivate and lead others.
Ability to work well within cross-functional teams
Demonstrates excellent oral communication and writing skills
Understanding of the Global and U.S. pharmaceutical marketplace and familiarity with medical terminology. Understands issues, problems, and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution.
Develops collaborative relationships to facilitate the accomplishment of work goals
Generates innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities
Shows ability to use appropriate interpersonal styles and techniques and can modify behavior to gain acceptance of ideas or plans
Can build networks to obtain cooperation without relying on authority
Strong sensitivity for a multicultural/multinational environment
Unquestionable ethics, professional integrity, and personal values consistent with company values
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