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Senior Regulatory Affairs Associate

Bengaluru, Karnataka, India Date posted 08/04/2020 Job ID 61300BR

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

  • Good understanding of regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions as well as knowledge of global pharmaceutical legislation and guidance specifically linked to regulatory CMC aspects in the ICH countries . Experience with ROW countries would be a plus.
  • Expertise in CTD / eCTD compilation and submissions, technical review of the submission documents as well as Post Approval activities: Renewal, Variations and other lifecycle management activities (preferably for Europe, USA and International markets would be an asset). Exhibit excellent CTD writing skills.
  • Comprehensive knowledge and experience with developing regulatory CMC strategies and CMC dossier content requirements
  • Products Portfolio includes: Medicinal Products, Consumer Health, Biologicals, Vaccines etc…
.Lead and / or contribute to the planning, preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions from either a global and/or regional perspective.
  • Liaise closely with cross-functional members with aligned product responsibilities.
  • Develop, execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
  • Identify regulatory risks and propose mitigations to Lead RPM and cross functional teams.
  • Support operational and compliance activities for assigned CMC deliverables, including generating work requests and submission content plans, submission tracking and document management utilizing the support and input of Global Regulatory Operations and Marketing Companies.
  • Must able to prepare, review and submit Administrative, CMC related, Labelling as well as Safety variations to Health Authorities and also perform post Approval related updates (where applicable)
  • Ensure that the Regulatory Information Management system is maintained and updated for all activities under role responsibility, including review of documents
  • Well versed with MA Transfers and related activities preferably for EU and international markets.
  • Strong knowledge and experience of CMC gap assessment and defining CMC action plans.
  • Determine the types of regulatory submissions or internal documentation that are required in situations.
  • Gap regulatory assessment (regulatory strategy) based on relevant HA requirements.
  • Preparing and Prioritizing the gap resolution dossier concerning the update of the MA dossier as needed
  • Supports Site regulatory product managers with regard Regulatory Gap assessments
  • Supports Site project teams and external stakeholders as part of project execution
  • Must able to handle Health Authority Queries, Change Control management as well as the coordination and follow ups with internal / external stakeholders and local RA affiliates.
  • Must able to perform Artwork reviews
  • Assist and provide support in the preparation, distribution and follow up of registration documentation required to affiliates/ regulatory authorities
  • Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance
  • Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents
  • Exhibits good project management skills.
  • Demonstrates ability to prioritize work and define steps needed to achieve specified project outcomes.
  • Ensure that quality standards are met and that the deliverables meet strict deadlines
  • Excellent interpersonal and intercultural communication skills, both written and verbal.
<>·Attention to details and ability to think strategically 
  • Multi-tasking ability.

Qualifications

B.Pharm or M.Pharm or any Life Sciences related discipline

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