15 Regulatory Affairs Director - Pharma Jobs in Boston, MA
KP Recruiting Group is Hiring a Regulatory Affairs Director - Pharma Near Boston, MA
KP Recruiting Group is a consulting firm that providesleadership and exceptional talent to some of the world’s leading companies.Headquartered in the Midwest, KP Recruiting Group has successfully completedcountless engagements across the United States. We represent clients in allindustries and all sizes. Our mission is to provide exceptional client andcandidate experiences in order to get the best possible results. On behalf ofour client, we are excited to present the following confidential role. We lookforward to hearing from you and discussing the opportunity!
The Role:
- Represents GRA as a core member of the cross functional project team and Global Brand team and provides overall regulatory input for the project(s) globally. In this capacity, the GRTL is the single point of contact for the business on regulatory issues for the project(s).
- The GRTL will ensure the development of robust global regulatory strategies, including Global Submission Strategy (GSS), for their assigned products and will be accountable for developing and maintaining a global regulatory product strategy document (GRPS)
- The GRTL will work transversally to ensure a properly functional regulatory sub-team. The GRTL facilitates the development and implementation of local regulatory strategy working with the regulatory platforms, regions and/or the countries.
- The GRTL is accountable to present the global regulatory strategy/position to senior management / governance committees as needed.
- The GRTL will work with the labeling strategists and regional groups to ensure appropriate labeling content based on the clinical program and Target Product Profile (TPP). The GRTL will also work with the labeling strategist and regions to develop region specific labels.
- The GRTL will ensure timely communications of relevant topics to the business and up through GRA senior Management. The communication of any HA feedback should be interpreted and the impact on the project assessed.
- The GRTL will research and analyze regulatory information and maintain current regulatory knowledge to keep abreast of regulatory procedures and changes
- The GRTL will ensure compliance with all internal and external requirements and procedures and may suggest improvement to operating policies/processes, as appropriate.
- The GRTL may line manage, and/or coach mentor, junior staff supporting the program
- Depending on the program assignment, the GRTL may also serve as the US/EU Regulatory Lead.
- Experience/Professional Requirement
- 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.
- Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy and guidance
- Excellent operational skills including planning, organizing and ability to motivate and lead others.
- Ability to work well within cross-functional teams
- Can demonstrate solid oral communication and writing skills
- Understanding of the Global (including US, EU and Japan in particular) pharmaceutical marketplace and familiarity with medical terminology.
- 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
Requirements
- Bachelor's degree and at least 8 years in Regulatory Affairs or relevant industry experience
- Master’s, PharmD, PhD degree and at least 6 years in Regulatory Affairs or relevant industry experience
- Education area of study in a scientific discipline/MS or Doctoral degree/Pharm D a plus.
Benefits
Our clientoffers a comprehensive benefits package including:
401kMatching
Family andIndividual Insurance Packages (Health, Life, Dental, and Vision)
Paid TimeOff & Paid Holidays
Long &Short-Term Disability
IdentityTheft Plans
Retirement& Pension Plans
EmployeeAssistance Program
EmployeeReferral Program
TuitionReimbursement Programs
Advancement& Professional Growth opportunities
ParentalLeave
& More
Job Summary
Full Time
Business Services
$120k-157k (estimate)
03/09/2024
05/08/2024
kprecruiting.com
Minneapolis, MN
<25
Business Services
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