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Senior Regulatory Affairs Consultant (Russia)

Moscow, Moscow, Russia Date posted 01/31/2019 Job ID 50271BR

As part of PAREXEL Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter – and keeping them there –your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical device companies large and small.

In return, you will be provided with interesting opportunities for growth and development and exposed to a variety of challenging assignments, product types, geographic regions, and therapeutic areas. Plus, as member of PAREXEL Consulting, you will enjoy all the advantages of working remotely, combined with access to the mentorship from a team of highly experienced regulatory professionals at the height of their careers. Join our team, and you will design solutions for the complexities of an ever-changing global marketplace.

  • Full Time
  • Level: Mid
  • Travel: Yes
  • Glassdoor Rating 3.5

Success Profile

What makes a successful Consultant at PAREXEL? Check out the top traits we're looking for and see if you have the right mix.

  • Detail-oriented

    10
  • Proactive

    10
  • Relationship expertise

    10
  • Problem-solver

    9
  • Results-driven

    9
  • Time Management

    9
  • Communicator

    8
  • Independent

    8
  • Multi-tasker

    8
  • "They say if you are passionate about what you do, you will never work a day in your life. I can honestly say that this applies to me. I love what I do."

    Jasen - Consultant
  • "My experience so far with PAREXEL has been great! I had initially started at PAREXEL as an Independent Consultant but was then presented with a full time job opportunity to really become a part of this fascinating company. I have enjoyed the flexibility to be able to orchestrate a good work/life balance, as well as learn from so many experts in consulting arena and really have a hands-on role with every day bringing a new but exciting challenge."

    Aqip – Consultant
  • "I was offered an incredible opportunity to continue my career in regulatory affairs without relocating 1,000 miles away and making major life changes. PAREXEL is an innovative, growing company which offers much needed flexibility and opportunities for professional growth."

    Blaine – Consultant
  • "PAREXEL is a very large organization and holds a top position amongst the different companies engaged in the Consulting business. It can offer many opportunities for development and career progression. Also the diversity of projects can offer a great expansion of knowledge in many areas of the Regulatory Affairs arena. Last (but not least), PAREXEL offers a variety of rewards to the employees (bonus scheme, benefits etc)."

    Giannis – Consultant
  • "PAREXEL is a CRO that I had always inspired to join because of the variety of knowledge, experts, culture, flexibility and exposure to be client facing as well as to use my technical knowledge all under a professional and diligent environment. I believe it has provided me the right platform to grow both professionally and individually with the opportunities to present my views and to dialogue with colleagues and clients with all but positive outcomes."

    Aqip – Consultant

Rewards

  • Global Impact

    We are one truly global team working together to propel each client´s journey ahead faster.

  • Balance

    We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.

  • Collaboration

    Work with industry leaders and subject matter experts.

  • Freedom

    The ability to innovate, ask “what if” and try new solutions without fear of failure.

  • Variety

    Opportunities to work on multiple accounts – never boring!

  • Management

    Strong management with depth of experience working for global health authorities.

Responsibilities

Job Function / Main Responsibility:

Ensuring timely and accurate performance of the processes of registration, re-registration, amendments to the documentation and pre-authorization pharmaceutical expertise.

Key Duties:
  • Manages all regulatory processes, in line with business objectives, to ensure timely filing of new products, line extensions, renewals and life-cycle management of UPSA products
  • Preparation of applications and files on the primary and secondary expert examination for authorization, re-authorization and amendments to the documentation on UPSA products
  • Preparation and coordination of analysis methods for expert examination for authorization, re-authorization and amendments to drugs' documentation
  • Monitoring the course of pharmaceutical expertise, ordering samples and standards
  • Regular interaction with regulatory bodies regarding product registration, compliance and safety - continuous control during the procedure, informing the head of the department about emerging issues in a timely manner, making suggestions for overcoming the issues
  • Responsible for the continuous updating of local labelling to accurately reflect Company Core Data Sheets (CCDS)/ reference labelling
  • Preparation and coordination of package inserts
  • Coordination and approval of the layout of package elements for authorization and sale
  • Regulatory assistance to the required advertising and promotion activities (materials and events) in compliance with local regulatory requirements and UPSA policies and procedures
  • Ensures compliance with local regulatory requirements regarding distribution, handling product complaints, withdrawals and recalls
  • Ensures that the head of GRS department is informed about key regulatory milestones and issues
  • Continuous improvement of professional training level: self-study, participation in seminars and training courses held by the company as well as outside the company – networking with the regulatory working group of the local Trade Associations
  • Compliance with the principles of teamwork : mutual aid, supporting team members, focus on the overall result
  • Continuous improvement of knowledge of the Russian legislation in the field of authorization, quality control of drugs, as well as in related areas (clinical trials, importation of drug samples, declaration and certification etc); preparation of relative information upon request
  • Maintaining GRS databases as appropriate

Qualifications

Education:
  • Pharmacist / Biologist
  • 5+ years of experience in Regulatory Affairs, including history of professional training's
  • Ability to work independently and act as a team player - establishes and maintains cooperative working relationships with peers and co-workers and has an excellent reputation, as a proactive well-respected team member, who willingly shares information and resources and brings value added input
  • Demonstrated ability to negotiate with people of various internal and external functions
  • Demonstrated ability in planning, problem solving, and time management
  • Complete knowledge of local regulatory requirements and processes
  • Experience in medicinal product (experience in OTC is a plus)
  • Knowledge of organisation structure and policies of Regulatory Authorities
  • Knowledge of the local pharmaceutical industry's environment
  • Experience in control of promotional materials
  • Experience with International Manufacturers (outside Russia)
  • CTA experience
  • Excellent communication skills - oral and written
  • Excellent command of the English language (oral and written)
Experience Desired
  • Experience of directly interacting with Health Authorities (Medicines, OTC, supply, lab)
  • Experience in Food supplements
  • Experience / Interactions with local trade associations

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