Company: BioMarin Europe Limited
Closing Date: 07 Jan 17
Salary (£): Competitive
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.
Senior Manager Regulatory Affairs
Reports to: Director, Regulatory Affairs
Since its foundation in 1997, BioMarin’s strong commitment to therapies for diseases with high unmet medical need and rare disorders, typically in children, has enabled it to forge a leading position in the field of rare diseases. BioMarin is a California based drug development innovator and retains the entrepreneurial thread consistent with its origins, making it a dynamic pharmaceutical company with passionate employees, creating innovative strategies and work practices in order to bring lifesaving treatments to patients as quickly as possible. Patients are at the heart of everything BioMarin stands for but BioMarin is also committed to its employees and strives to maintain the work/life balance which is reflected in consideration of employee’s geographical locations when working with colleagues in HQ in California.
This appointment is primarily focused on supporting the expanding portfolio of development molecules, as well as providing support to post marketing activities dependent upon the business needs. The role will focus on developing and delivering on European Regulatory strategy, and will require the individual to have a flexible and enthusiastic attitude, with strong attention to detail and time management skills and a track record of engagement and building good relationships with internal stakeholders and regulatory agencies.
Given the nature of the diseases that BioMarin seeks to develop treatments for, this role will provide the scope to utilize your experience to develop and deliver on innovative regulatory approaches supported by world class science and exceptional in-house experience in the development and maintenance of products for rare diseases.
Support the program EU regulatory leads in executing on program strategy and deliverables, may take the lead on the strategy and execution of deliverables for one or more programs as required by the needs of the business and the EU regulatory team
Ensure European regulatory requirements are identified and implemented into development and pre and post-authorization regulatory activities.
Contribute to the strategy, planning, preparation, submission and maintenance of MAA’s, CTA’s, ODD’s, PIPs, Regulatory Agency meetings, Protocol Assistance etc as required for assigned programs
Represent the EU RA department in cross-functional project teams, engage with and give regulatory support to program regulatory and development teams, and commercial, medical and clinical colleagues
Support process improvement initiatives, standards development, and metrics
Interact with staff from EMA and other EU national agencies
Provide guidance to all appropriate departments in BioMarin to ensure compliance with applicable regulations.
Remain knowledgeable about current and evolving EU regulations and guidance
Educated to at least first degree level in a scientific discipline
Extensive regulatory experience gained within a Pharma/Biotech Company or with an EU regulatory authority
Experience of both development and pre-/ post-authorization activities, in particular with a track record in execution of strategy for development products
Orphan drug experience is preferable.
Skilled at gathering supportive information and developing EU regulatory approaches for development and pre- and post-authorization activities,
Proven ability to manage critical projects as a part of a multifunctional (matrix) team
Proven ability to successfully interact with regulatory authorities
Prior experience managing regulatory submissions with the ability to successfully manage projects to deadlines
Ability to multitask; manage multiple products and deliverables and independently resolve problems and identify areas of opportunity
Thorough understanding of relevant drug development regulations and guidelines
Proficient with computer and standard software programs. Experience with electronic submissions such as eCTDs and working with an electronic Document Management System is desirable.
Outstanding interpersonal, negotiation and communication (written and verbal) skills
The candidate must interact with project team members from BioMarin as well as partner and with regulatory project managers and other staff from EMA and other national or international health authorities.
A large extent of stakeholders and team members will be based on the West Coast of the US
Standard computer skill required (MS Office, Acrobat Powerpoint etc)
Experience in working on an eCTD in an eDMS is desirable.
Note: This description is not intended to be all-inclusive or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
All employment offers and resumes are managed through our Human Resources Department and all candidates are presented through this avenue. Therefore, the Human Resources Department at BioMarin requests that recruiters are not to contact BioMarin employees directly in an attempt to present candidates. Complying with this request will be a factor in determining future professional relationships with BioMarin.
BioMarin will not accept unsolicited resumes from any source other than directly from candidates for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the recruiter does not create any implied obligation on the part of BioMarin.
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.
10 Bloomsbury Way 5th Floor London
|Website:||Visit Our Web Site|
PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.