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Associate Director, Regulatory Affairs CMC
Adaptimmune
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Associate Director, Regulatory Affairs CMC

Adaptimmune

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Details
Posted:
April 8, 2021
Location:
Philadelphia, Pennsylvania
Type:
Full Time - Experienced
Categories:
Biotechnology, Quality/Risk Management, Regulatory Compliance, Worldwide Regulatory Affairs
Required Education:
4 Year Degree

Primary Responsibility

We are seeking a highly motivated and experienced individual for an Associate Director position in global Regulatory Affairs CMC. This position will provide CMC regulatory leadership and act as the point of contact on cross-function teams to support the strategy and development of our T cell therapies for the treatment of cancer. 

Key Responsibilities

Provides CMC Regulatory leadership, serving as an expert for global regulatory CMC requirements and emerging trends for cell therapy products

Acts as point of contact to cross-functional teams on regulatory CMC project issues. Ensures project teams, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.

Actively collaborates with internal teams (Technical Development and Manufacturing, including Supply Chain and Quality, external partners and CROs) to develop and execute robust CMC regulatory strategies

Plans, executes, and manages regulatory CMC submissions including BLA/MAA, INDs, CTAs/IMPDs, briefing documents, responses to queries

Leads interactions with FDA and other Health Authorities for CMC-related topics (including management of regulatory deliverables and commitments)

Ability to remain current on CMC regulatory intelligence including guidelines and regulatory trends, and to drive and implement strategic policy decisions

Evaluates change proposals for global regulatory impact and plans global amendments

 

Qualifications & Experience

Required

  • Bachelor’s Degree required; advanced degree preferred
  • Minimum of 8 years of pharmaceutical/biotech experience including 5 year of Global Regulatory Affairs (CMC) experience
  • Experience with pharmaceutical development of drug substance or drug products, analytical characterization, process scale-ups and or regulatory registration of products.
  • Understanding and proven ability to provide strategic guidance to drug development, registration, and post-market support teams. Provides regulatory advice, making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance
  • Proven experience with filing and maintenance of regulatory dossiers (CTAs, INDs, IMPDs, BLAs/MAAs)
  • Proven ability to liase with Regulatory Agencies having served as lead in successful Agency interactions related to CMC submissions and product development meetings; international experience preferred
  • Knowledge of relevant domestic and global regulations and guidance
  • Ability to work effectively in cross-functional teams

Desirable

  • Experience as a RA CMC product lead strongly preferred
  • Experience in cell and gene therapy or biologics is strongly preferred
  • Experience with BLAs/NDAs/MAAs strongly preferred

Skills & Competencies

Required

  • Exercise outstanding judgment in all areas of responsibility
  • History of successful interactions with global regulatory authorities
  • Energetic, self-motivated and a hands-on professional with a strong work ethic
  • Able to perform independently and think analytically and creatively to solve problems
  • Effectively lead and manage multiple time-sensitive projects
  • Ability to be a true team player working toward common goals
  • Excellent written and oral communication and interpersonal skills required to enable optimal interactions both internally and externally
  • An ability to be productive and successful in an intense work environment
  • Willing to travel domestically and internationally up to 15%

NOTES:
Employer will assist with relocation costs.
Internal Number: 1
About Adaptimmune
Our Vision Arming Cells. Against Cancer. For Good. Our Mission To Transform the Lives of People with Cancer by Designing and Delivering Cell Therapies As a leader in T-cell therapy, we are at the forefront of immunotherapy research, and offer exciting career opportunities for those eager to join us and share in our passion for patients. We’re at the forefront of immunotherapy research Fifteen years ago, Adaptimmune scientists began to uncover the mysteries behind how immune cells recognize human disease. Today, the company has applied this expertise to build a superior proprietary T-cell engineering platform that enables the company to overcome common challenges of reprogramming the immune system to reverse disease processes. Adaptimmune is now at the forefront of transforming immunotherapy and developing a broad pipeline of optimized engineered T-cell therapies to treat cancer and other serious conditions. We excel in fostering the right company culture for our people We are proud to be have been awarded 'Great Places to Work UK' and 'Best Places to Work US' in 2020. For us, every employee matters as each of us contributes to achieving our mission. We strive to create a culture where people can develop and have a rewarding career with an inspiring purpose.
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