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Regulatory Affairs Manager

Petaling Jaya, Selangor, Malaysia Date posted 04/11/2019 Job ID 51885BR

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

Check out the top traits we're looking for and see if you have the right mix.

  • Detail-Oriented
  • Proactive
  • Problem-Solver
  • Results-Driven
  • Organized
  • Multi-Tasker
  • "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

• Works within a team environment or individually based on the project needs
• Works within broad project guidelines and facilitates issue and conflict resolutions
• Prioritizes own work load and may prioritize the work load of the project team in order to achieve the project scope
• Capitalizes on opportunities to improve project efficiency, results or team performance and proactively takes action
• Produces quality work that meets the expectations of PC and the client. Reviews the work of colleagues for content and quality to ensure the expectations of the client and PC are met
• Manages small projects and may manage larger project engagements
• Interacts with the assigned Project Assistant (PA) to ensure accurate financial management and for general project support
• Provides guidance to project team members, and acts as a mentor to junior staff
• Facilitates client decision making by framing issues, presenting options and providing objective business advice
• Collaborates with colleagues, as needed, to discuss and facilitate resolution of problems or conflicts. Provides guidance as needed to lower level colleagues on appropriate methods of executing project activities
• Acts as a trusted advisor to clients and/or project team on technical and/or process issues
• Delivers assigned work and provides services and solutions which results in clients expressing satisfaction with service provided and occasionally results in additional business or referrals
• Identifies opportunities for follow-on business or changes in project scope and exploits the opportunities with PC management and account management
• Actively participates in project scoping calls and proposal preparation
• May deliver sales presentations and participate in bid defense meetings when needed
• Contributes information to support the account planning process and integrated marketing programs

Qualifications

*A licensed pharmacist
*Good project management knowledge
*Excellent interpersonal and intercultural communication skills, both written and verbal
*Client-focused approach to work (Quality)
*Results orientation
*Teamwork and collaboration skills
*Consulting skills
*Critical thinking and problem-solving skills
*More than 7 year working experience in regulatory filed
*Proficiency in local language and extensive working knowledge of the English language

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