Sr. Manager, Regulatory Science - Innovative Gene Therapies

Location
Boston, Massachusetts
Posted
Oct 04, 2018
Required Education
Bachelors Degree
Position Type
Full time

Sr. Manager, Regulatory Science - Innovative Gene Therapies

Boston, Massachusetts, United States · Regulatory Affairs

DESCRIPTION

Location: Boston, MA
Reporting to: Vice President, Regulatory Science

Orchard Therapeutics is an international biotechnology company dedicated to bringing transformative gene therapies to patients with serious and life-threatening rare diseases. Orchard is a fast-growing and well-funded company with ground-breaking science and a broad pipeline that includes several products in late stage development and at least one BLA planned for the coming year. With locations in London and California, and a new US headquarters in Boston’s Seaport District, Orchard is building its Boston regulatory team with several newly-created roles for dynamic regulatory professionals who aspire to excellence and have the skills and mindset to work in the leading edge of gene therapy science.
 

Responsibilities

The Sr. Manager of Regulatory Science will support the Regulatory Lead for at least one late stage asset and other pipeline projects and may assume RL role for early stage product. This role offers an unparalleled opportunity for exposure to regulatory vehicles such as orphan, breakthrough therapy, rare pediatric disease, and RMAT designations, as well as the full spectrum of regulatory activities to support clinical development and approval including a BLA planned for the coming year. As part of the regulatory science team, this role will have a real and timely impact on the development and approval of therapies with the potential to transform patients’ lives.

Under the guidance of the Regulatory Lead, the successful candidate will:

- Contribute to defining and implementing regulatory strategy for assigned programs to expedite clinical development and approval of important therapies for unmet medical needs

- Independently prepare routine regulatory submissions and assist with complex/large submissions

- Draft applications for designations for expedited programs (eg, Breakthrough Therapy, RMAT) or special status (eg, Orphan Drug) and portions of other submissions

- Contribute to regulatory agency meeting planning, preparation and conduct

- Participate in negotiations with regulatory agencies to resolve issues, and prepare and submit responses to questions

- Develop and maintain regulatory submission tracking and archiving in EDMS

- Participate in regulatory intelligence activities; monitor regulatory guidelines and trends

- Assist in the development and maintenance of departmental processes, policies, SOPs, and associated documents

- Performs other related duties as required by position

 

REQUIREMENTS

Qualifications

  • B.S. or higher level degree in a scientific discipline preferred
  • At least 5 years of experience in Regulatory Affairs, ideally in biologics
  • Working knowledge and understanding of FDA regulations and guidelines
  • Exposure to a global cross-functional team environment
  • Excellent organizational skills and strong attention to detail; and ability to prioritize effectively and handle multiple tasks
  • Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment and to interact efficiently with Regulatory Authorities

 

BENEFITS

The successful candidate will enjoy a competitive base salary and the opportunity to participate in incentive compensation programs, including an annual bonus and a stock option plan. Orchard Therapeutics, Ltd. offers a comprehensive benefits program, including: medical, dental and vision care; paid vacation and holiday time; and access to a voluntary 401(k) with company match. Orchard Therapeutics is an equal opportunity employer.

To apply for this role, or for further information, please email HR@orchard-tx.com