Sr Regulatory Affairs Manager

Pay 70-79/h depending on experience

OVERVIEW:
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.

The Regulatory Affairs Nonclinical / Clinical team plays a key role in defining the 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.

SUMMARY DESCRIPTION
The Reg Nonclinical / Clinical Associate Director will lead, conceive, communicate and execute upon the global clinical and nonclinical regulatory strategies throughout a program’s lifecycle that are in alignment with corporate goals and timelines. This includes formulating the global Nonclinical / Clinical strategy for the Global Regulatory Plan, acting as the key liaison with Health Authorities and leading the preparation of Nonclinical / Clinical documentation to support global regulatory filings, including post-approval activities and life-cycle expansion opportunities.
The Associate Director is viewed as a subject matter expert in the functional area involved in developing, modifying and executing on product strategies and have a function and may have a companywide impact. The AD will typically collaborate, influence and negotiate with senior Nonclinical / Clinical leaders on product strategies and actions leveraging their advanced Nonclinical / Clinical knowledge.

RESPONSIBILITIES

Regulatory Strategy Development
• Lead the development, integration, execution and maintenance of the global nonclinical and clinical regulatory strategy for the Global Regulatory Plan (GRP) throughout the product lifecycle. Ensure strategic alignment with the Clinical Development Plan (CDP) and nonclinical development plan with input from clinical and nonclinical Subject Matter Experts (SMEs), respectively, and regional regulatory leads.
• Provide strategic insight to the GRT regarding product development, and serve as Regulatory contributor to partner teams (eg, study execution teams, clinical development team etc.) as appropriate
• In collaboration with regional regulatory representatives, ensure that feedback from global Health Authorities is incorporated into the global nonclinical and clinical development strategy.
• Incorporate RA INTL guidance on development programs (i.e., INTL requirements or policies that may impact clinical development and commercialization).
• Develop global pediatric strategy; collaborate with regional leads on the content for regional pediatric plans (e.g., PIP); ensure global pediatric strategy is reflected in the Global Regulatory Plan; ensure any changes to CDP or Nonclinical development plans are assessed by regional leads for impact to pediatric plan agreements with Health Authorities.
• Lead/support strategy for life-cycle expansion opportunities
Clinical and Nonclinical Development Plan Advancement
• Act as a key contributor to the Clinical and Nonclinical Development Plans and ensure that they incorporate consideration of current global health authority precedents and regulatory guidance.
• Provide both proactive and reactive strategic input and regulatory expertise in the design and conduct of clinical and nonclinical studies
• Contribute critically to the scientific interpretation and integration of clinical and nonclinical study results.
• Review and provide comments on all company- sponsored abstracts, manuscripts and publications of original research and press-releases, as requested.
• In collaboration with Regulatory Affairs functional management, coordinate the provision of resources from the various Regulatory functions in support of clinical studies.
Health Authority Meetings
• Lead planning and preparation of the clinical and nonclinical strategy and content for global HA meetings, working closely with SMEs and regional regulatory leads. Deliverables include core content for the briefing book, presentation, and the Q&A strategy map.
• Lead clinical and nonclinical FDA interactions in alignment with corporate and/or program goals.
• Serve as the point of contact for FDA regarding nonclinical/clinical communications.
• Ensure that global HA feedback is incorporated into the clinical and nonclinical aspects of the development programs.
Regulatory Submissions and related activities
• Broadly, ensure that the clinical and nonclinical content is adequately presented in submissions leading to successful clinical trial applications and product approvals.
• Oversee any CRO/vendors that are contracted to perform any of the regulatory activities related regulatory submissions and HA interactions
• IND/CTAs:
o Lead planning and preparation of core clinical and nonclinical content for global clinical trial applications, collaborating with SMEs and regional regulatory representatives.
o Lead collaboration with CROs to support global clinical trials in line with corporate goals.
o Coordinate maintenance of IND/CTAs globally through clinical trial completion.
o Directly responsible for nonclinical/clinical aspects of US FDA IND submissions.
o Partner with regional regulatory representatives to confirm CTA requirements as needed (i.e., confirm information provided by CROs)
o Maintain IND/CTAs through end of clinical studies
o Facilitate US clinical trial results postings on CT.gov
• Marketing Applications (MAs):
o Lead the creation of the clinical and nonclinical content of core CTD / global dossier for use in global marketing applications, collaborating with SMEs and regional regulatory representatives.
o Serve as RNC lead on MA Filing Team to support global MA preparation, submission, review through approvals
o Directly responsible for nonclinical/clinical aspects of US marketing applications, maintaining US license and ensuring fulfillment of any PMRs/PMCs

EDUCATION AND EXPERIENCE
• 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