Manager, Regulatory Operations

Location:  San Rafael, California Category: Regulatory







Job Title:

Manager, Regulatory Operations

Department / Cost Center:

Regulatory – 243

Reports to (Job Title):

Senior Manager, Regulatory Operations

Job Code:



San Rafael Campus (SRC)

Date Prepared:

January 2020



Full-Time     Part-Time



Regular     Temporary



Exempt     Non-Exempt




State the overall function or purpose of the job.

Since its foundation in 1997, BioMarin has brought 6 products to market, with 7 more in the pipeline, over half a billion dollars of revenue and a global footprint in 40 countries. We are a recognized industry leader in rare disease development.

Consistent with our origins is an entrepreneurial thread, making us a dynamic pharmaceutical company with passionate employees, creating innovative strategies in order to bring lifesaving treatments to patients as quickly as possible. Our patients are at the heart of everything we stand for and we seek individuals for whom significance and contribution to improving the patients' lives is a key driver.

Our Regulatory Affairs organization, made up of a team of over 100 dedicated professionals, continues to grow. If you are an experienced Regulatory Operations Manager with strong eCTD publishing skills, project and management skills, interested in working in an environment where you’ll have the resources and infrastructure to tangibly impact the lives of patients, we want to speak with you.



List the major responsibilities of the job.

  • This position will oversee submission planning (including scheduling and resource allocation), formatting, publishing (including QC), transmitting and archiving regulatory submissions in both paper and electronic media to health authorities in the US, EU, CA and Rest of World.
  • This position may manage internal Regulatory Operations personnel as well as the activities of external consultants.
  • The position will also oversee the development and maintenance of processes, templates, standards, and guide sheets.
  • The position must be able to oversee applications and systems support (including Livelink Knowledge Management), systems training programs, and supporting development projects within Regulatory Affairs. Other duties as assigned.
  • This position interacts with Regulatory Affairs and departments providing information to be submitted (including but not limited to Clinical, Nonclinical, and Quality).
  • This position requires extensive knowledge of MS Office, Adobe Acrobat, Livelink and InSight Publisher.
  • This position requires the ability to exercise discretion, independent judgment and clearly identify priorities, as well as to work overtime in order to meet required timelines.



Quantify the scope or impact of the job in terms of revenue, expenses, capital investment, headcount, etc.

Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.  Uses professional concepts and company's policies and procedures to solve a wide range of difficult problems in imaginative and practical ways.



State both the minimum and the preferred educational attainment (or equivalent experience), and describe essential and desired subject matter, certifications, special training, etc.

Bachelor’s Degree desirable.



State both the minimum and the preferred number of years of relevant experience, and describe the essential functions of the job.

  • At least 4 years of experience in Regulatory Operations OR at least 3 years of experience in Regulatory Operations, InSight Publisher certification, and 2 years of related experience.
  • Minimum 1-2 years of direct management experience desirable.
  • Must be highly proficient in MS Office 2013 (with an emphasis on MS Word) and Adobe Acrobat (version XI Pro or DC preferred). Strong knowledge of eDMS and eCTD Publishing Systems (Livelink and InSight Publisher preferred). Must have extensive experience with electronic submissions, specifically eCTD.
  • The candidate should have proven ability to manage critical projects as part of an interdisciplinary team. In addition, the candidate should have experience managing major regulatory submissions, with the ability to successfully manage projects to deadlines.
  • The candidate is expected to have a thorough understanding of relevant submission formatting, transmittal and archiving regulations and guidelines and to have outstanding interpersonal and communication (written and verbal) skills and effective task planning and coordination abilities. Must be able to interpret guidelines and effectively implement



Describe the work environment characteristics that an employee encounters while performing the essential functions of the job.

The employee may frequently be required to sit and talk or hear.  The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell.  The employee must occasionally lift and/or move up to 25 pounds.  Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.



Describe any equipment required to perform the job.

Equipment will be provided.



List the key positions, internal and external, with which the job incumbent must interact.

The candidate must interact with project team members from BioMarin as well as partner company(ies) and with regulatory project managers from US FDA or international health authorities.



List the number of personnel directly reporting to this position and their job titles.  List the number of personnel functionally reporting to this position (i.e., supervised on a “dotted-line” basis), and their job titles.  Specify the total number of personnel supervised by this position, both directly and through others.

Two to three Personnel (Specialists/Associates/Temporaries) will directly report to this position. The total number of personnel supervised by this position, both directly and through others, will be defined at the time of hiring.



List the key accomplishments and skills that must be achieved to be eligible for promotion to the next position, if any, on the career ladder.

To be considered for promotion, the individual should already be consistently functioning at the highest level described for their current position. The individual will show skills have advanced to the next position level as listed in the Regulatory Operations Career Matrix.