Senior Manager, Regulatory Affairs

Location
Boston, MA, United States
Posted
Aug 27, 2020
Ref
2D7F973403
Hotbed
Genetown
Required Education
Masters Degree/MBA
Position Type
Full time
Location: USA - Boston, MA or Remote

Reporting to: Senior Director, Regulatory Science

Job Summary:

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 Regulatory Lead role for early stage products. The Sr. Manger will be also work closely with the Global Regulatory Lead (GRL) to provide regional updates on regulatory-related activities and provide any regulatory intelligence updates to the team. The person in this role will work on a variety of tasks independently while also contributing to team projects and goals, as well as supporting company-wide objectives.

Key Elements and Responsibilities:

This role offers an unparalleled opportunity for exposure to regulatory vehicles such as INDs, orphan products, breakthrough therapy, rare pediatric diseases, 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 gene therapies with the potential to transform patients' lives.

Required Knowledge:

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 (eg, Annual Reports)
  • 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
  • Work closely with Regulatory Operations and other functional team leads
  • 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
  • Be involved in gathering Regulatory intelligence
  • Remain current on Guidances, Directives, Regulations, ICH Guidelines

Skills & Abilities:

  • Extensive Regulatory experience
  • Relevant/Recent experience with Rare/Orphan disease indictation(s) desired
  • Previous experience with gene and/or cell therapies desired, but not required
  • Performs other related duties as required by position
  • Advanced degree (Masters, PhD, PharmD) desired, but not required
  • Knowledge of eCTD INDs, CTAs BLAs/NDAs/MAAs, Orphan Drug Designations, history of Health Authority (HA) Interactions
  • Experience with document repository systems (e.g. EDMS, Veeva, CTMS, etc.)
  • Proficiency with computer systems (e.g. Word, Excel, PowerPoint, Adobe Pro, Smartsheet, etc.)

Education:

  • College/University Degree required, preferably in the Sciences


Orchard is an equal opportunity employer. We recognise and celebrate the diverse culture of our workforce and are committed to creating an inclusive environment for our employees. We fully support the principle of Equality and Diversity in employment and oppose all forms of unlawful or unfair discrimination. We assess all applications on basis of job requirements and individual qualifications.

We work within the requirements of all current legislation and we implement the provisions of regulatory codes of practice in employment.

Notice to All Applicants: Orchard Therapeutics participates in E-Verify

RECRUITERS

All employment offers and CV's are managed through our Human Resources Department and all candidates are presented through this avenue. Therefore, the Human Resources Department at Orchard Therapeutics requests that recruiters are not to contact Orchard Therapeutics employees directly to present candidates. Complying with this request will be a factor in determining future professional relationships with Orchard Therapeutics. Orchard Therapeutics will not accept unsolicited resumes from any source other than directly from candidates for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the recruiter does not create any implied obligation on the part of Orchard Therapeutics.

[JH1]In the US this terminology is more common than Regulatory Science

Requirements

Skills & Abilities:
  • Extensive Regulatory experience
  • Relevant/Recent experience with Rare/Orphan disease indictation(s) desired
  • Previous experience with gene and/or cell therapies desired, but not required
  • Performs other related duties as required by position
  • Advanced degree (Masters, PhD, PharmD) desired, but not required
  • Knowledge of eCTD INDs, CTAs BLAs/NDAs/MAAs, Orphan Drug Designations, history of Health Authority (HA) Interactions
  • Experience with document repository systems (e.g. EDMS, Veeva, CTMS, etc.)
  • Proficiency with computer systems (e.g. Word, Excel, PowerPoint, Adobe Pro, Smartsheet, etc.)


Education:
  • College/University Degree required, preferably in the Sciences


Orchard is an equal opportunity employer. We recognise and celebrate the diverse culture of our workforce and are committed to creating an inclusive environment for our employees. We fully support the principle of Equality and Diversity in employment and oppose all forms of unlawful or unfair discrimination. We assess all applications on basis of job requirements and individual qualifications.

We work within the requirements of all current legislation and we implement the provisions of regulatory codes of practice in employment.

Notice to All Applicants: Orchard Therapeutics participates in E-Verify

RECRUITERS

All employment offers and CV's are managed through our Human Resources Department and all candidates are presented through this avenue. Therefore, the Human Resources Department at Orchard Therapeutics requests that recruiters are not to contact Orchard Therapeutics employees directly to present candidates. Complying with this request will be a factor in determining future professional relationships with Orchard Therapeutics. Orchard Therapeutics will not accept unsolicited resumes from any source other than directly from candidates for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the recruiter does not create any implied obligation on the part of Orchard Therapeutics.