Senior Manager, Regulatory Affairs

Location:  London, United Kingdom Category: Regulatory

Description

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives. 
 
 

SUMMARY DESCRIPTION

This position will be responsible for regulatory activities supporting centrally authorised commercial products and associated CTAs, principally in the EU. Duties for other projects may also be assigned. This position will be required to interact frequently with the regulatory department in California.

 

RESPONSIBILITIES

    • Lead management of MAA and provide EU support for Commercial Launch
    • Post-authorisation PIP maintenance and the submission of modifications and annual reports.
    • Lead REG planning, preparation, and submission of clinical trials
    • Support planning, preparation, and submission of MAAs as necessary
  • Provide contributions to support product life-cycle strategy.
  • Manage interactions with EMA or other regulatory authorities
  • Customarily and regularly exercise discretion and independent judgment in the performance of the duties described above.
  • Other duties as assigned.

 

EDUCATION

BSc degree in life sciences (Advanced degree is desirable).

 

EXPERIENCE

  • Desirable to have at least five-years’ experience in Regulatory Affairs in the biotechnology industry
  • Exposure to both development and commercial phases of the product lifecycle
  • Proven ability to successfully interact with regulatory authorities
  • Experience with Orphan Drugs is desirable
  • Skilled at working independently and as part of a team, gathering regulatory information and developing product approval strategies
  • Proven ability to manage critical projects as a part of an interdisciplinary team
  • Preferable to have experience interacting with regulatory authorities, including helping with the preparation for key regulatory meetings
  • Prior experience managing regulatory submissions (e.g. CTAs, MAAs) to ensure successful in time submissions to support the strategic and operational objectives
  • Prior experience supporting development of briefing documents
  • Thorough understanding of relevant EU drug development regulations and guidelines
  • Proficient with computer and standard software programs
  • Outstanding interpersonal and communication (written and verbal) skills
  • Effective task planning and coordination abilities

WORK ENVIRONMENT / PHYSICAL DEMANDS

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 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.

 

CONTACTS

The candidate must interact with project team members from BioMarin as well as partner company(ies)/CROs and with regulatory project managers from EMA or other international health authorities.A large extent of stakeholders and team members will be based on the West Coast of the US.

 
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.