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Senior Regulatory Affairs Strategy Consultant - Program Lead

USA - Any Region - Home Based Date posted 06/14/2022 Job ID 74431BR

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

We currently have an amazing opportunity to join Parexel’s Regulatory Consulting Team as a Senior Regulatory Affairs Consultant for a large multinational dedicated client partnership!

As a Senior Regulatory Affairs Consultant you will partner with the client as a strategic program lead and:
  • Provide senior level, experienced regulatory leadership to satisfy expected industry standards, applying in-depth knowledge of client and regulatory requirements and guidelines, procedures and best practices, including compliance.
  • For assigned project(s), as requested and monitored by the client project lead(s)/team(s), act as an accountable agent on behalf of client to the FDA and via client affiliates as applicable to work with ex-US Health Authorities - and lead and support regulatory team (cross sub functions of regulatory including documentation, CMC, submissions, labeling) or equivalent members for related activities.
  • Provide experienced stakeholder management interfacing directly with internal stakeholders of various levels.
  • Additional regulatory- and project-related support activities/Services as requested by the client project lead(s)/team(s).

Qualifications

To ensure success, you will have:
  • Previous regulatory affairs experience in a clinical role in industry, previous exp with small molecule or biologic product experience is highly preferred.
  • Graduate (Bachelors) Degree required (life sciences disciplines strongly preferred)
  • Advanced Degree (post graduate; e.g. PhD, PharmD, M.Sc.) in a related field is strongly preferred
  • Average of 10 or more years’ relevant clinical experience in regulatory affairs (US, EU, ROW); including extensive knowledge of clinical drug development, submission requirements and Health Authority interactions.
  • Knowledge and deep experience of the drug development process from IND/CTA opening through final product approval, and how other functions contribute to a regulatory submission (IND/CTA/IMPD, NDA/BLA/ANDA/MAA, etc.).
  • Knowledge of GxP, ICH, and other regulatory guidelines; experience in providing regulatory assessments and guidance including considering precedence and relevant HA guidance through many project-level activities.
  • Fully competent in strategic agility, communication (stakeholder management), leadership, pharma drug development, organizational and business knowledge. · Level of direct therapeutic area experience is role dependent.
  • Experience in regulatory affairs (US, EU, ROW); experienced in submission requirements and HA interactions.
  • Strong regulatory program management, leadership, teamwork, and communication skills.
  • Fully competent in teamwork (cross functional)/collaboration, achieving results, regulatory knowledge, operational excellence.
  • Impeccable ethics.
  • Outstanding attention-to-detail and accuracy
  • Is regarded as a subject matter expert, is respected by others, and can effectively contribute to long-range product development and consistently leads cross-functional teams to successful results
  • Strong business acumen: has in-depth knowledge of the pharmaceutical/biotechnology industry, the multiple functions and roles involved in the product development process.
  • Can effectively contribute to the development of disease strategies and plans
  • Excellent project management skills: can prioritize multiple tasks and goals to ensure the timely, on-target and within-budget accomplishment of such
  • Strong interpersonal, verbal communication and influencing skills: can influence without authority and has proven experience building and cultivating relationships with key partners and stakeholders, both internally and externally
  • Outstanding written communication skills
  • Strong business presentation skills: effective at summarizing and presenting the key considerations and decision points
  • Confident and competent when interacting with varying levels of internal/external management: stays focused and on-point, is able to raise problems or challenges in a productive and mature manner
  • Strong negotiation skills: can effectively drive discussions and decisions toward desired end-results
  • Strong cross-functional teaming skills: has consistently excelled in cross-functional teams and regularly demonstrated him/herself as a leader among peers
  • Aptitude or proven ability to guide the work of others (can lead and motivate others, as well as prioritize and oversee their work through to successful outcomes)
Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.

EEO Disclaimer

Parexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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