To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.

About our client
Our client is into brand and generic pharmaceutical products. It develops, manufactures, markets and distributes such products. The Corona-based specialty pharmaceutical company has one of the broadest product offerings in the US generics industry and a track record of service excellence. It is well known as a reliable and low-cost provider of quality pharmaceutical products.
Position	Location
Director of Regulatory Affairs	California
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Direct FDA regulatory strategies and support all development drug products 2) Ensure company products are approved on time 3) Lead cross-function project teams in FDA negotiations for the therapeutic area 4) Demonstrate ability to contribute, in a leadership role, to fastest development and approval of drug products 5) Maintain positive and proactive collaborations with Legal, Technical Research and Development, Sales and Marketing and Operation Departments 6) Review submissions critically for appropriate scientific rationale and strategic impact 7) Direct resources utilization of the department to maximize efficiency and ensure that time lines are met
Requirements
1) M. Sc degree preferred 2) Minimum 7 or more years of experience in regulatory affairs along with pharmaceutical environment preferred 3) Extensive knowledge and experience of US regulatory affairs 4) 4+ years of line management experience in multi-disciplinary scientific and technical staff preferred 5) Ability to maintain good working relationships with various FDA members at a divisional level 6) Strong entrepreneurial spirit with a track record of taking intelligent risks, courage in decision-making and willingness to be held accountable 7) FDA, ANDA, SOP and GMP experience 8) Extreme command over the drug development process, pharmaceutical business and strategic portfolio management 9) Competence in analysis and problem-solving skills 10) Ability to prioritize and make trade-offs to achieve goals 11) Management experience coupled with strong interpersonal, oral and written communication skills 12) Ability to interact effectively across boundaries with other functional groups 13) Willingness to push teams to think strategically, creatively and proactively 14) Ability to train and develop direct reports