9533 Senior Associate – Regulatory Affairs
Duties:
The Company is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.
We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children.
These conditions are often inherited, difficult to diagnose, progressively debilitating, and have few, if any, treatment options.
The Company aims to improve life and health outcomes for people with rare diseases by advocating the use of innovative therapeutics, advancing the standard of care and providing personalized support and services globally.
The Global Regulatory Affairs (GRA) is responsible for obtaining approval for new products and ensuring that approval is maintained throughout the product lifecycle.
GRA serves as the interface between the regulatory authorities and the program teams aiming to ensure that the project plan correctly anticipates what the regulatory authority will require before approving the product.
It is the responsibility of GRA to keep abreast of current legislation, policies, guidelines and other regulatory intelligence.
The RA department plays an important role in giving advice to the program teams on how best to interpret the regulatory legislation and guidelines.
Regulatory Affairs Nonclinical / Clinical team plays a key role in defining the Company’s regulatory strategy and pathway for a product by leading the development and execution of the nonclinical / clinical regulatory strategy and plan in alignment the overall clinical development plan.
This team will take a lead role in planning and developing relevant sections of regulatory filings required for product approvals.
In addition, this team will lead planning, coordinating and engaging directly with Health Authorities before, during and after regulatory approval milestones.
The Senior Associate supports the Global Regulatory Lead in the development and execution of global nonclinical / clinical regulatory strategy.
The Senior Associate will support the efforts to preparation for HA interactions and complete regulatory submissions.
The RNC Senior Associate responsibilities may vary depending upon product regulatory activities and may include the following:
Support the development of the nonclinical / clinical regulatory strategy and plan.
Assist with selected planning, document development and meeting execution activities in preparation for HA meetings / interactions.
Participate in Study Execution Teams for assigned products and identify relevant regulatory considerations for discussion with the Global Regulatory Lead.
Collaborate with CROs that are contracted to perform regulatory submissions/HA interactions for global clinical trials.
With oversight, develop and coordinate the core nonclinical / clinical content of regulatory submissions.
Responsible for ensuring high quality nonclinical/clinical content that adheres to regulations and guidelines.
Support the maintenance of IND/CTAs.
Assist with the preparation of HA submission packages including but not limited to compiling relevant materials (Protocols, Annual Reports, Briefing Books, etc.) and completing regulatory documents/forms for internal review.
Attend relevant functional area and project team meetings.
Review, understand and stay up to date on regulations, guidelines relevant to responsibilities.
Review documents (SOPs, protocols and reports) related to Clinical or Nonclinical studies, as necessary.
Ensure that the PM timelines and tracker accurately reflect submission plans.
Skills:
Decision Making and Problem Solving, including an understanding of decision-making models and methodology.
Influence, Cross-Functional Collaboration and Organizational Awareness, including demonstrating professional maturity, including understanding own strengths and receptivity to feedback.
Agility and Proactivity, including an ability to recognize, understand, articulate and respond promptly to issues, risks and opportunities that arise.
Communication, including preparing and editing written material that is technically accurate and grammatically correct.
Strategic Thinking and Planning, such an ability to set short-term and longer-term goals for individual objectives and task completion.
Regulatory Strategy, Frameworks and Processes: Demonstrates basic understanding of regulations, guidelines and pathways including when and how to file routine submissions; asks appropriate question to clarify / validate understanding.
Health Authority Engagement: Knows basics of how relevant health authorities function, their general structure and the key personnel.
Scientific Writing for Regulatory Submissions: Demonstrates basic knowledge of content guidelines and structures (sections, etc.) for writing routine regulatory submissions (i.e., annual reports).
Drug Development and Study Design: Understands the objectives/purpose of each drug development phase and the related objectives and regulatory requirements, including as it relates to rare disease development.
Scientific and Medical Knowledge: Demonstrates basic knowledge of relevant therapeutic area, disease conditions and unmet medical needs.
Education:
Degree in health or life sciences, including chemistry, molecular biology, or similar. PhD preferred, Masters/Bachelors acceptable with relevant experience.
2 + year experience with PhD; 4+ years with Masters, 6+ with bachelor’s degrees.
Nonclinical / Clinical Regulatory Affairs experience preferred.