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Guidehouse Associate Director-Life Sciences Practice-Regulatory Pharma/Biotech Consulting in Boston, Massachusetts

Overview

Guidehouse is a leading management consulting firm serving the public and commercial markets. We guide our clients forward towards new futures that build trust in society and your professional skills along the journey. Join us at Guidehouse.

Responsibilities

Guidehouse is currently looking for an Associate Director, Regulatory Affairs, Quality and Patient Safety to be both an innovative solution lead and to be involved in shaping and growing the Regulatory area of our Life Sciences team. Candidates should be market-facing, self-starters who bring with them a high level of ownership over their work, an enthusiastic attitude and a collaborative mindset to support our efforts to sell and provide regulatory and development consulting solutions for Pharmaceutical and/or Biotech companies of all sizes.

As a Key Contributor You Will deliver high-level consulting to clients and colleagues using a broad field of expertise while managing complex Regulatory issues.

Key Responsibilities and Activities:

  • Consult pharma/biotech clients regarding specific questions and innovations regarding Regulatory strategy in cooperation with Head of Regulatory Affairs

  • Provide strategic consultancy during development, NDA/ANDA/BLA filing and post-approval maintenance

  • Manage and lead maintenance solutions, including change control and quality supplements as well as gap analysis and due diligence services

  • Contribute to client Clinical Development plans and Clinical Endpoint strategies. Advising on Agency requirements, guidelines and precedents.

  • Advise clients on Agency registration pathways, Orphan designations, Pediatric plans and other requirements where appropriate.

  • Develop customer-specific solutions and processes in cooperation with clients

  • Facilitate and assist clients with Target Product Profile planning and exercises

  • Manage and oversee quality management issues, including remediation of 483s and Warning Letters

  • Drive business development activities in the area of Regulatory as well as build, develop and maintain working relationships with clients

  • Oversee and lead writing activities as well as compilation of quality dossiers (CTD modules 2.3 and 3, IND, DMF)

  • Collaborate in designing the division/department strategy with the Head of Regulatory Affairs

  • Project management of complex Regulatory projects, especially in the context of IND and NDA/BLA filings as well as Compliance

  • Lead client interactions with regulatory agencies

  • Provision appropriate expertise regarding area of expertise

  • Advancements of processes and/or tools within defined area of expertise

  • Mentor employees within the practice field of activity. Provide scientific support, guidance and coaching of team members

  • Gather/create/share experiences in area of expertise with focus on "best practices"

  • Keep update to date in area of Regulatory and maintain role as subject matter expert

Qualifications

Required Education, Experience, Skills and Competencies:

  • BA/BS degree in Science, Biomedical Engineering, Healthcare, Business or related course of study, advanced degree/PhD

  • 12+ yrs. total years of relevant life science industry (direct / through consulting) specifically pharmaceutical, biotech, and/or specialty pharma, with extensive professional experience, broad/generalist knowledge spectrum for role preferably as an executive consultant

  • Experience with emerging products such as gene/cell therapy is a plus

  • Strong demonstratable knowledge with Regulatory Affairs US as well as FDA approval guidance for pharma/biotech product planning and development. Must have specific experience in regulatory requirements including: design, development, project management and guidance; target product profile activities; quality management systems implementation, maintenance and remediation (6+yrs. of complex work/results in many of these areas)

  • Demonstrated success selling that can translate into ability to generate, annually, $1.5M+ of business within Regulatory group and/or larger Life Sciences team

  • Ability to deliver high-level strategic guidance while maintaining full comprehension of, and ability to speak to, all details

  • Ability to define strategic goals for Guidehouse regulatory consulting team, as well as strategic goals of partnerships with clients (e.g. contribution to RFP responses for large consulting or managed service projects)

  • Ability to lead large international and/or complex project teams, supporting and leading team members in difficult change management situations

  • Extensive network with regulatory decision makers in pharma/biotech and an ability to manage client relationships on VP level and to convey strategic goals of collaboration

  • Ability to travel Post COVID up to 50%

Preferred/Desired Skills:

  • Drives solutions to complex problems impacting company success

  • Experience in adjacent areas of expertise or willingness to broaden the knowledge/to build up knowledge in complementary fields of expertise

  • Recognized as a subject matter expert by industry

  • Previous FDA/agency experience preferred

  • Active member of relevant societies

  • Demonstrated history of thought leadership and speaking engagements

  • Ability to balance client requests and company interests

  • Ability to analyze and solve problems, and to develop pragmatic solutions at higher (e.g., company) level

  • Proven capability to communicate critical issues and proposed solutions to senior management levels and successfully manage stakeholders even in critical or sensitive situations

  • Ability to adapt under regularly changing conditions

  • Very good command of English – written and verbal

  • Outstanding organization, analytical and problem-solving skills

  • Excellent written, verbal and presentation communication skills

Additional Requirements

The successful candidate must not be subject to employment restrictions from a former employer (such as a non-compete) that would prevent the candidate from performing the job responsibilities as described.

Disclaimer

About Guidehouse

Guidehouse is an Equal Employment Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, citizenship status, military status, protected veteran status, religion, creed, physical or mental disability, medical condition, marital status, sex, sexual orientation, gender, gender identity or expression, age, genetic information, or any other basis protected by law, ordinance, or regulation.

Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance including the Fair Chance Ordinance of Los Angeles and San Francisco.

If you have visited our website for information about employment opportunities, or to apply for a position, and you require an accommodation, please contact Guidehouse Recruiting at 1-571-633-1711 or via email at RecruitingAccommodation@guidehouse.com. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation.

Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Guidehouse and Guidehouse will not be obligated to pay a placement fee.

Rewards and Benefits

Guidehouse offers a comprehensive, total rewards package that includes competitive compensation and a flexible benefits package that reflects our commitment to creating a diverse and supportive workplace.

Benefits include:

  • Medical, Rx, Dental & Vision Insurance

  • Personal and Family Sick Time & Company Paid Holidays

  • Parental Leave and Adoption Assistance

  • 401(k) Retirement Plan

  • Basic Life & Supplemental Life

  • Health Savings Account, Dental/Vision & Dependent Care Flexible Spending Accounts

  • Short-Term & Long-Term Disability

  • Tuition Reimbursement, Personal Development & Learning Opportunities

  • Skills Development & Certifications

  • Employee Referral Program

  • Corporate Sponsored Events & Community Outreach

  • Emergency Back-Up Childcare Program

  • Position may be eligible for a discretionary variable incentive bonus

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