Sr Regulatory Affairs Manager

Akkodis is seeking an Associate Director for a 12 month Contract job with a client in Novato CA 94949 (Onsite). Ideally looking for applicants with a solid background in the Pharmaceuticals / Biotechnology industry is a must.

Rate Range : $70 / hour to $80 / hour ; The rate may be negotiable based on experience, education, geographic location, and other factors.

Summary :

The Associate Director of Regulatory Affairs leads global clinical and nonclinical regulatory strategy, overseeing IND / CTA submissions, marketing applications (CTD / BLA / NDA / MAA), and all FDA / global Health Authority interactions. The role guides clinical and nonclinical development plans, integrates regulatory intelligence, manages CROs, supports Paediatric (PIP / PSP) strategy, and ensures successful approvals and lifecycle management.

Required Skills :

• Global regulatory strategy (clinical + nonclinical)
• IND / CTA leadership and maintenance
• Marketing application development (CTD / BLA / NDA / MAA)
• FDA and global Health Authority meeting experience
• Clinical & nonclinical study design knowledge
• Paediatric strategy (PIP / PSP)
• Regulatory writing (briefing books, submissions, dossiers)
• CRO / vendor oversight
• Strong scientific and regulatory interpretation skills

If you are interested in this role, then please click APPLY NOW. For other opportunities available at Akkodis, or any questions, feel free to contact me at ravi.singh@akkodisgroup.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 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 in accordance with federal, state, and local laws and / or security clearance requirements, including, as applicable :