7645 Senior Manager, Regulatory Affairs

Summary:
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.
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.
The RA department plays an important role in giving advice to the program teams on how best to interpret the regulatory legislation and guidelines.
The Regulatory Nonclinical/Clinical (RNC) team plays a key role in defining the regulatory strategy and pathway for a product by leading development and execution of the nonclinical / clinical regulatory strategy in alignment to 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 and lead planning and engaging directly with Health Authorities (HAs) before, during and after regulatory approval milestones.
The Senior Manager supports Regulatory leadership in the development and execution of global regulatory strategies through a program’s lifecycle, including preparation for HA interactions and the oversight of regulatory submissions, in support of the strategy and may take on a leadership role for key submissions and HA engagement activities as delegated.
The Senior Manager will work collaboratively in a cross functional environment on a diverse range of topics that require in-depth Nonclinical/Clinical knowledge, understanding of industry trends and analytical ability to develop options and solutions for presentation to, and approval by, senior leadership.

The RNC Sr. Manager responsibilities may vary depending upon product regulatory lifecycle and may include the leadership of selected activities and may include the following:
Support 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 RNC Lead.
Collaborate with CROs that are contracted to perform regulatory submissions/HA interactions for global clinical trials.
With oversight by RNC lead, develop and coordinate core nonclinical / clinical content of regulatory submissions.
Responsible for ensuring high quality nonclin/clinical content that adheres to regulations and guidance’s.
Lead maintenance of IND/CTAs and assist with the preparation of HA submission packages including but not limited to Protocols, Clinical Study Reports, Briefing Books, etc.
Collaborate with Reg PM to create and align submission timelines, collaborate with Reg Ops to provide final documents and QC published outputs for submissions to HA.
Organize and maintain the administrative, nonclinical, and clinical portions of IND’s, NDA’s and BLA’s.
Oversee the archiving of HA submissions and correspondence.
Attend relevant functional area and project team meetings.
Review, understand and stay up to date on regulations, guidelines relevant to responsibilities.

Skills:
Decision Making and Problem Solving, such as skill in identifying relevant stakeholders, explaining issues/solutions, and soliciting feedback when gathering facts about problems, issues, risks or opportunities.
Influence, Cross-Functional Collaboration and Organizational Awareness, such as skill in building understanding of the organizational structure, key decision-making processes and governance and communication channels.
Agility and Proactivity, including an ability to anticipate risks or issues to program or business and take the necessary steps to mitigate or address.
Leadership, such as skill in clearly communicating objectives, goals, and expectations to others.
Communication, including an ability to provide context and articulate key messages effectively and with appropriate level of detail.
Strategic Thinking and Planning, such as an ability to anticipate and plan for near-term opportunities and issues for the function.
Regulatory Strategy, Frameworks and Processes: Demonstrates comprehensive understanding of regulatory requirements across the drug development lifecycle; accurately articulates impact on current phase of development.
Health Authority Engagement: Demonstrate a comprehensive understanding of the internal processes required to prepare for HA interactions including the key deliverables such as strategy maps, and rehearsal preparation materials.
Scientific Writing for Regulatory Submissions: Comprehensive understanding of regulatory content requirements, submission templates, sections and writing style requirements for portions of complex submissions (i.e., clinical trial applications and portions of marketing applications).
Drug Development and Study Design: Understands how nonclinical and clinical studies fits into overall product objectives, strategy, required filings, and regulatory commitments.
Scientific and Medical Knowledge: Understands the implications of competitive product developments on therapeutic area regulatory strategies / plans.

Education:
Degree in health or life sciences, including chemistry, molecular biology, or similar.
PhD preferred, Masters/Bachelors acceptable with relevant experience.
6 + year experience with PhD; 8+ years with Masters or bachelor’s degrees.
Nonclinical / Clinical Regulatory Affairs experience preferred.
year of line management experience preferred.

The hiring range for this position is $65 to $75 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on the candidate’s geographic region, job-related knowledge, skills, and experience amongst other factors.

Harvest Technical Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other federal, state, or local protected class.