Associate Director Regulatory Affairs

  •  

Jersey City, NJ

Industry: Pharmaceuticals & Biotech

  •  

8 - 10 years

Posted 4 days ago

  by    Michelle Manzon

Job Summary

Title: Associate Director – Regulatory Affairs

Company: Biopharmaceutical

Type: Permanent Role

Notes: No Corp to Corp

Responsibilities:

· Develop and implement global regulatory strategies encompassing clinical, non-clinical and CMC disciplines to support the development of multiple early development and late development drug candidates.

· Requires leadership in the development and execution of regulatory strategy with the help of cross-functional project teams and supports interactions with global health authorities and corporate partners with regulatory deliverables and management of regulatory team.

· Lead the preparation, review, assembly and submission of regulatory documentation such as INDs, other regulatory equivalents, IMPDs, expedited program designations, orphan drug applications, annual reporting and pediatric plans.

· Represent Regulatory Affairs in multi-disciplinary teams and senior management for regulatory strategies and development of early and late stage development programs.

· Coordinate and consult with subject matter experts on the content, review and publication and assembly of regulatory documentation

· Lead the strategy and prepare for Health Authority meetings

· Serve as primary liaison with Health Authority for assigned projects

· Provide advice and guidance to project teams on the interpretation and application of relevant regulatory requirements and applicable guidance.

· Manage and build the regulatory group and manage the work of others by providing guidance to his/her team. Manage budgets and project timelines, identify and address gaps in planning and resourcing.

Requirements:

  • Bachelor's degree in a life sciences, chemistry, or related discipline with minimum 8 years of experience in Regulatory Affairs. Advanced degreepreferred.
  • Experience working with US and/or ex-US health authorities.
  • Execute work in a detail-oriented manner and guide the successful completion of all submissions. Have strong written and verbal presentation skills.
  • Strong analytical thinking and organization skills.
  • Responsible for maintaining a working knowledge of regulatory requirements and guidelines and for communicating changes in regulatory information to departmental and team colleagues. Has good general knowledge of other related disciplines. Able to work and communicate well within a multidisciplinary project team and to manage multiple projects simultaneously.

Salary

$180K - $ 200K