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Job Details

Senior Manager Regulatory Affairs

Company: BioMarin Europe Limited
Location: Moscow
Reference: 12717
Closing Date: 23 Dec 16
Type: Permanent
Salary (£): Competitive
Benefits: Yes

Job Summary:

This position will be based at the BMRN office in Moscow, Russian Federation. The purpose of this position is to support regulatory affairs activities for new product registrations and life-cycle maintenance of marketed products in Russia and CIS (Belarus/Kazakhstan and Ukraine as of now) region.

Requirements:

Senior Manager Regulatory Affairs

 

Reports to (Job Title): Director, EUMEA Regulatory Affairs

Location: Russia

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 Development Sciences group is responsible for everything from research and discovery to post-market clinical development. Development Sciences 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 based at the BMRN office in Moscow, Russian Federation.  The purpose of this position is to support regulatory affairs activities for new product registrations and life-cycle maintenance of marketed products in Russia and CIS (Belarus/Kazakhstan and Ukraine as of now) region.

RESPONSIBILITIES

Provide regulatory support to regional RA lead located in Turkey including:

Assist in managing project timelines, planning and preparation of complex submissions such as: marketing applications (MAs). Assist with writing or updating of various sections of MAA and/or GMP including the administrative, labeling, nonclinical, and clinical portions of MAs to ensure submissions are prepare in accordance with regional requirements

Collaborating with corporate (US / EU) RA leads to communicate regional regulatory strategy for submissions, including potential risks and gating factors, to internal stakeholders located at headquarters.

Assist in the preparation of Agency meetings (meeting requests, briefing book, strategy maps).

Performing regulatory intelligence searches and draft reports summarizing product registration and other regulatory requirements. 

Evaluating local regulations/guidance for impact to any complex submission (e.g., MA) while ensuring that elements, quality, accuracy and format of regulatory submissions comply with applicable laws and regulatory standards.

Interfacing with external partners, contractors and some regulatory authorities as needed.

Participate in a multi-functional team environment and help direct and implement local regulatory strategy.

Serve as a regulatory representative on various project sub-teams and address a broad range of problems of moderate scope.

Must possess excellent communication skills in order to successfully liaise and influence internal/external stakeholders and communicate critical aspects of ongoing project activities. Interpersonal responsibilities will include working closely with project and other regulatory team members.

Performing promotional material review (PRB projects) for Russia/CIS

Up to 30% travel is possible

Reports directly to the Director, EUMEA Regulatory Affairs (MEA/Russia/CIS/EEC)

EDUCATION

BA/BS degree in life sciences minimum. Advanced degree a plus.

EXPERIENCE

Experience in Regulatory Affairs in the biotechnology or pharmaceutical industries, including an in-depth knowledge and understanding of the Russia/CIS Regulatory environment.

Proven ability to independently manage critical projects as part of an interdisciplinary team. Experience managing major regulatory submissions, with the ability to successfully manage multiple projects with competing deadlines.

Ability to work under limited direction and guidance.

Possess a thorough understanding of relevant drug development and post-marketing regulations and guidelines.

Must have outstanding interpersonal and communication (written and verbal) skills and effective task planning and coordination abilities. Proficiency with computer and standard software programs is required.

Must be fluent in Russian and English. Other language(s) is a plus.

SUPERVISOR RESPONSIBILITY

At the time of hiring, there will be no personnel directly reporting to this position.

CONTACTS

The candidate must interact with regional RA leads, and other project team members from BioMarin, partners, and consultants/contractors.

EQUIPMENT

The candidate will be required to use a laptop computer in a docking station. A desktop phone also will be necessary to perform the job.

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.

RECRUITERS

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.


#LI-DNI

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.

Apply for this job: Senior Manager Regulatory Affairs

Contact Information:

Address:  Head Office
10 Bloomsbury Way 5th Floor London
WC1A 2SL
England
Tel:  44 (0)207-420-0800
Website:  Visit Our Web Site

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