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Senior Director, Regulatory Affairs

United States of America - Remote - Northeast Date posted 08/06/2022 Job ID 84143BR

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

If you love building and leading teams, have a passion for regulatory affairs, and are well versed at strategic and operational management of regulatory projects, consider joining Parexel's Regulatory Consulting Team as a Senior Director, Regulatory Affairs! In this role you will work alongside a wonderful, dedicated and driven leadership team and make an impact each and every day!

A Senior Director, Regulatory Affairs will be responsible for building and leading a team of highly skilled regulatory professionals, interacting with clients for oversight of projects, and providing regulatory and strategic consulting.

Key Accountabilities-

Project Execution:

  • Monitors profitability of multiple projects through active involvement in the preparation of project plans and management of project budgets Prevents and resolves issues with revenue recognition

  • Works within a team environment or individually based on project needs

  • Provides guidance to project team members and acts as a mentor to junior staff

  • Works within broad project guidelines and leads issue and conflict resolution

  • Prioritizes own workload and prioritizes the workload of the project team in order to achieve the project scope and objectives

  • Capitalizes on opportunities to improve project efficiency, results or team performance and proactively takes action

  • Leverages information from previous projects or other client work to efficiently complete assigned project activities as well as facilitate business decisions

  • Produces quality work that meets the expectations of the business unit and the client. Reviews the work of colleagues for content and quality to ensure the expectations of the client and the business unit are met

  • Manages project engagements as a project lead (small or large)

  • Interacts with the assigned Project Assistant (PA) to ensure accurate financial management and for general project support

  • Follows all required Business Operating Process (BOPs) for pre-initiate, initiate, execution, close and monitoring of projects

Staff Management:

Actively manages performance including typical HR activities for direct reports (i.e. performance management forms, salary actions, bonuses, scorecards)

  • Provides input on staff to appropriate SBU, BU, and Functional leaders

  • Provides applicable guidance and support to staff in order for staff to succeed and achieve key metrics. Holds staff accountable to key metrics

  • Facilitates staff development plans and coordinates with project staffing to ensure that staff is utilized completely and appropriately

  • Coordinates with project staffing to provide staff with opportunities to expand skill sets

  • Rewards staff appropriately

  • Provides leadership, coaching, mentoring, feedback and role modeling to managers and extended staff to ensure quality and accuracy of services as well as achievement of key metrics

  • Communicates and champions organizational vision and values

  • Regularly communicates with staff to assure effective two-way information flow (i.e. business updates, staff interests, issues, and/or concerns)

  • Monitors engagement/morale of direct reports

  • Provides feedback on succession planning to align individual staff capabilities with the current and future needs of the organization

  • Assures Parexel policies and procedures are communicated to line personnel

Consulting Activities & Relationship Management:

  • Plans and delivers services and solutions which result in clients expressing satisfaction with service provided and builds relationships which result in additional business or referrals

  • Identifies opportunities for follow-on business or changes in project scope and exploits the opportunities with sr. management and account management

  • Provides a full range of technical and/or business consulting services across multiple disciplines of services including representing clients to regulatory agencies

  • Acts as a trusted advisor to clients, often on issues that lack precedent or are not clearly defined.

  • Acts as a loaned executive for a client when required

  • Completes and delegates project activities in a timely manner with an understanding of issues which may impact project profitability and client satisfaction

  • Facilitates resolutions to possible problems or conflicts within the project team and/or the client.

  • Provides guidance as needed to colleagues on appropriate methods of executing project activities

  • Develops and implements business solutions addressing specific client needs using expertise, best practices and knowledge of the client’s business and key industry drivers

  • Demonstrated ability to interact professionally at multiple levels including senior and executive management within a client organization

Business Development:

  • Actively prospects and leverages new business opportunities with client and industry contacts in collaboration with Account Management

  • Presents information about the organizations service offerings reflecting the organization’s capability to support client needs

  • Delivers customized sales presentations focused on the client’s needs. Actively engaged in bid defense meetings when needed

  • Generates new or repeat business due to personal name recognition or history of client satisfaction and/or relationship

  • Leverages rainmaking skills resulting in new and repeat business for PAREXEL. Is responsible for constant monitoring of his/her “A” list, and is expected to have continued contact with both existing and future potential clients

  • Participates in project scoping calls and proposal preparation

  • Delivers sales presentations and participates in bid defense meetings when needed

  • Actively participates in account planning for key clients

Parexel related responsibilities:

  • Meets established metrics as specified in scorecard on an annual basis

  • Completes basic job-related responsibilities, including timesheets, expense

  • reports, maintenance of CVs, project deliverable archiving, participation in

  • internal initiatives/projects or as a mentor as requested by management

  • Defines self-development activities in order to keep current within the

  • industry (i.e. maintain membership in a relevant industry and/or

  • scientific/technical association)

  • Maintains cross-SBU relationships

Skills:

  • Influencing others

  • Client-focused approach to work

  • Networking

  • Results orientation

  • Business analysis

  • Excellent interpersonal and intercultural communication skills, both written and verbal Teamwork and collaboration

  • Critical thinking and problem-solving skills

  • Holding people accountable

  • Operational leadership

  • Leading change

  • Strategic business thinking

  • Consulting skills

  • Project management knowledge

  • Proficiency in local language and extensive working knowledge of the English language

Knowledge and Experience:

  • Numerous years of experience in the life sciences or consulting industries with many years of experience managing direct reports in a global matrix organization, directing teams and projects to include building and developing a team of regulatory professionals

  • Prior service provider, consulting industries or CRO experience, preferred

Education:

  • Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree (MSc, PhD) Preferred

15-20% travel may be required

Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.


#LI-REMOTE

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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