Sr Regulatory Affairs Manager Job at Akkodis, Novato, CA

UE5QU3dwV0NlUzNDQXFabHdWemNXVTlSU3c9PQ==
  • Akkodis
  • Novato, CA

Job Description

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.

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit .

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:

· The California Fair Chance Act

· Los Angeles City Fair Chance Ordinance

· Los Angeles County Fair Chance Ordinance for Employers

· San Francisco Fair Chance Ordinance

Job Tags

Hourly pay, Contract work, Temporary work, Local area,

Similar Jobs

Pride Health

Validation Technician Job at Pride Health

 ...Pride Health is seeking a Validation Technician for a medical device manufacturer operating in various areas, including medical-surgical solutions, dental solutions, health information systems, and purification and filtration. Job Title: Validation Technician... 

Voleon

Project Manager, Fund Finance Job at Voleon

 ...executive leadership ~ Strategic thinker with a commercial mindset and a high level of business judgment ~ Bachelors degree in Finance, Accounting, Economics, or related field; MBA or other advanced degree a plus ~ Authorization to work in the United States... 

OSI Engineering

User Research Assistant Job at OSI Engineering

 ...headquartered in Cupertino, CA is currently looking for a User Research Assistant to join the AIML User Research team. You will assist...  ..., and interacting with participants, ideally in-person and remote Previous experience managing multiple projects of different... 

Global Contracting Group

Heavy Diesel Mechanic Job at Global Contracting Group

 ...Job description Title: Heavy Equipment Diesel Mechanic- Experienced Company: Global Contracting Group, LLC. Location: Medley, FL (MIAMI, FLORIDA AREA) Contact: Trey Powell (***) ***-**** or Chris Goble (***) ***-**** Global Contracting Group is a large-... 

Hotel Weyanoke

Bartender - Hotel Weyanoke Job at Hotel Weyanoke

Join the Team at Hotel Weyanoke - Where every Pour Tells a StoryStep behind the bar at the Hotel Weyanoke and become part of a team...  .... Were looking for a friendly, engaging, and professional Bartender to craft exceptional guest experiences one drink, one smile,...