Regulatory Affairs Manager

Akkodis is seeking a Regulatory Affairs Manager for a 12+ months contract wit h a client located in Novato CA

Pay Range : $75 / hr. - $79.00 / hr. (The rate may be negotiable based on experience, education, geographic location, and other factors.)

Summary :

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.

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

Health Authority Meetings

Regulatory Submissions and related activities

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

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 / PMC

Education and experience :

If you are interested in this Regulatory Affairs Manager job in Novato CA , please contact Nitesh Kumar at (610 206 0160) or Nitesh.Kumar@akkodisgroup.com. For other opportunities available at Akkodis go to www.akkodis.com

Equal Opportunity Employer / Veterans / Disabled

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an EAP program, commuter benefits, and a 401K plan. Our benefit offerings provide employees with the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Disclaimer : These benefit offerings do not apply to client-recruited jobs and jobs that are direct hires to a client.

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The Company will consider qualified applicants with arrest and conviction records by federal, state, and local laws and / or security clearance requirements, including, as applicable :