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Senior Manager, Regulatory Affairs

Bengaluru, Karnataka, India Date posted 05/27/2021 Job ID 70184BR

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.

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
  • "When submitting major market applications, it’s key to ensure that the technical integrity of all data meets regulated requirement standards. Parexel makes this possible with a diverse team of seasoned professionals who care about getting important medicines to patients. This is Regulatory Operations at its best."

    Chris – Associate Director, Regulatory & Access
  • "In this role, I have had the unique opportunity to work with regulatory experts who are not only some of the most distinguished in their field, but are also some of the most compassionate people I know. I’ve been able to grow so much professionally by standing on the shoulders of giants!"

    Riley – Regulatory Affairs 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

Supports business by ensuring direct reports and all departments involved in a project have the necessary information to accomplish the sponsor’s needs and the One Parexel philosophy. Models fostering a collaborative organization to staff and peers.• Serves as a change agent who messages, interprets, and implements corporate strategy when changes occur and ensures staff understands and aligns to objectives. This may require 1:1 discussions, coaching, team meetings, and feedback to senior management.• Utilizes communication plans, FAQs, employee survey results, and action plans provided by senior management to relay positive attitude and personal endorsement/alignment to staff relative to a change. Provides justification that support the rationale about the change proactively and effectively to the staff and seeks their feedback.• Ensures their personal projects and projects of their line achieve customer satisfaction by monitoring performance of staff/teams, quality and timeliness of deliverables, management of scope and budget, and recommends solutions when there are challenges. Takes corrective actions relative to survey results or customer feedback as needed.• Supports operational efficiency and quality standards to meet business objectives by using the provided dashboards, reports, and business processes to ensure TIME billing practices, expense reporting, training, and the utilization results and forecast of direct line is accurate. Takes action to drive improvements and prevent quality issues. Ensures personal 50% utilization target is achieved by proactively seeking assignments. Ensures team utilization is achieved by appropriate resource allocations. • Demonstrates proactive and helpful communication practices by keeping line reports informed on status updates, new initiatives, expectations, financial results, lessons learned, etc. by sharing and collecting feedback Creates an environment where team members are comfortable to express and resolve questions and concerns.

Qualifications

Post graduate in pharmacy or life sciences

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