Regulatory Program Director
Welcome to Genentech, a leading biotechnology company dedicated to discovering and developing life-changing medicines for patients around the world. We are currently seeking a highly skilled and motivated Regulatory Program Director to join our team and play a critical role in shaping the future of our company. As the Regulatory Program Director, you will have the opportunity to lead and drive the regulatory strategy for our innovative pipeline of products. This is an exciting opportunity for a dynamic and forward-thinking individual who is passionate about making a difference in the lives of patients and who has a strong understanding of regulatory requirements and experience in leading successful regulatory submissions. If you are a driven individual with a strong track record of success in the biotechnology industry, we invite you to apply and join us in our mission to develop life-saving therapies.
- Develop and lead the regulatory strategy for the company's innovative pipeline of products.
- Ensure compliance with all relevant regulatory requirements and guidelines.
- Collaborate with cross-functional teams to develop and execute regulatory plans.
- Provide regulatory guidance and support to project teams.
- Lead the preparation, submission, and maintenance of regulatory submissions.
- Monitor changes in regulations and communicate potential impacts to the organization.
- Establish and maintain relationships with regulatory authorities.
- Lead and manage regulatory meetings and interactions with regulatory agencies.
- Provide strategic input and guidance to senior leadership on regulatory matters.
- Ensure timely and accurate communications of regulatory updates and decisions to internal stakeholders.
- Oversee the training and development of regulatory team members.
- Identify and mitigate potential regulatory risks.
- Collaborate with other departments to ensure alignment and consistency in regulatory strategies and submissions.
- Drive continuous improvement in regulatory processes and procedures.
- Stay current with industry trends and best practices in regulatory affairs.
Extensive Knowledge Of Regulatory Compliance: The Ideal Candidate Should Have A Deep Understanding Of Regulatory Guidelines And Requirements, Specifically In The Pharmaceutical Industry. This Includes Experience With Fda Regulations, Ich Guidelines, And Other Global Regulatory Bodies.
Strong Leadership Skills: As A Program Director, This Individual Will Be Responsible For Managing A Team Of Regulatory Professionals. Therefore, They Should Possess Excellent Leadership Skills, Including The Ability To Motivate And Develop Team Members, Delegate Tasks Effectively, And Handle Conflicts.
Excellent Communication And Interpersonal Skills: The Role Of A Regulatory Program Director Requires Working Closely With Cross-Functional Teams, External Stakeholders, And Regulatory Agencies. Strong Communication And Interpersonal Skills Are Essential For Building And Maintaining Relationships, As Well As Effectively Communicating Complex Regulatory Information.
Proven Track Record Of Successful Regulatory Submissions: The Candidate Should Have A Strong Track Record Of Successful Regulatory Submissions, Including New Drug Applications (Ndas), Biologics License Applications (Blas), And Marketing Authorization Applications (Maas). This Demonstrates Their Ability To Navigate The Regulatory Landscape And Ensure Timely Approval Of Products.
Advanced Degree In A Relevant Field: A Minimum Of A Bachelor's Degree In A Scientific Or Technical Field Is Typically Required For A Regulatory Program Director Role. However, An Advanced Degree, Such As A Master's Or Ph.d., In A Relevant Field, Such As Pharmacy, Chemistry, Or Biology, Is Highly Preferred And May Be Required For More Senior Positions. This Educational Background Demonstrates A Strong Understanding Of The Scientific And Technical Aspects Of Drug Development, Which Is Essential For Regulatory Strategy Development.
Quality Assurance
Project Management
Data Analysis
Leadership
Compliance Management
Risk assessment
FDA regulations
Cross-Functional Collaboration
Clinical Trials
Regulatory Strategy
Pharmacovigilance
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
Attention to detail
Teamwork
collaboration
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Regulatory Program Director in South San Francisco, CA, USA is $135,000 to $175,000 per year. This can vary depending on factors such as experience, industry, and company size. Some positions may also offer bonuses or additional compensation.
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Genentech, Inc., is a biotechnology corporation which became a subsidiary of Roche in 2009. Genentech Research and Early Development operates as an independent center within Roche. As of February 2020, Genentech employed 13,638 people.
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