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POINT Biopharma is an innovative, high-performance company focused on a hard problem: creating new cancer therapies that are more effective and have fewer side effects than traditional treatments. Our products are targeted radioligands, a technology that hold significant promise to treat cancer. Our company is growing rapidly: we just announced a phase 3 clinical trial for our novel radioligand based prostate cancer treatment, established our U.S. manufacturing center in Indianapolis, and have a pipeline of next generation oncology products in development. We are a creative and agile team accountable to a high standard: to be uniquely better. If you are searching for new and uniquely better career path, you should consider joining the POINT team.

TO BE CONSIDERED, APPLICANTS MUST BE LEGALLY ENTITLED TO WORK IN THE USA.

Location of work

The position will be working remotely with the anticipation of travel for team and client meetings. Currently, our employees are working remotely and located within the Eastern Time Zone. To work in synergy, it is preferred that our applicants are working within the same Eastern Time Zone to accommodate team and client meetings.

 

Overview

Reporting to the EVP of Regulatory Affairs, the Director of Regulatory CMC oversees and directs all chemistry, manufacturing, and controls (CMC) regulatory strategies for late stage development products.

 

Objectives

  • Serves as the primary contact to FDA and other health authorities and leads CMC meeting preparations, rehearsals and/or meetings
  • Provides guidance and support to internal groups such as marketing, quality, and manufacturing as well as to outside groups such as contract manufacturing organizations to ensure that products are manufactured in compliance with all applicable regulations.
  • Provides strategic input and risk assessments and oversees preparation of CMC regulatory submissions.

 

Accountabilities

  • Represents regulatory and/or leads matrix team strategy discussions for CMC activities for late stage products (through commercialization)
  • Authors, plans, manages timelines, reviews regulatory CMC documents (eCTD Module 3) and coordinates cross functionally to ensure thoroughness, accuracy and timeliness for CMC and other relevant sections of NDAs, ANDAs, amendments, supplements, etc
  • regulatory, company standards and scientific/technical requirements
  • Determine regulatory requirements for CMC and GMP related submissions and enquiries.
  • Accountable for developing and leading the regulatory strategy and contingency plans for CMC interactions globally
  • Monitors, interprets, and proactively assess developments in guidance’s, regulations, practices, and policies related to CMC, (ICH, GMP, NRC) and in general to radiopharmaceutical products, anticipate and communicate changes in requirements that may impact Point’s portfolio
  • Collaborates with clinical, medical affairs and commercial in supporting discussion on lifecycle management
  • Review all CMC and GMP related documents for submission to regulatory authorities to assure compliance with
  • Independently provide strategic guidance/input related to current global regulatory requirements.
  • Independently manage and prioritize multiple complex projects
  • Point of contact for FDA and other health authorities for CMC submissions and CMC-related issues
  • Participate in business development meetings as requested
  • Develop and maintain collaborative relationships with other local and/or global functional units [Clinical Development, Manufacturing and Quality] as well as affiliates, external partner companies, contract manufacturers, packagers, and suppliers etc
  • Effectively manages and/or directs internal support staff and external consultants for assigned projects.

 

Requirements

  • Advanced scientific degree (biology, chemistry, pharmacy) with 8-10+ years professional regulatory experience, with minimum of 5 years CMC regulatory strategy in industry or government. Knowledge of Oncology product development working with global (US, CA, EU, UK) multidisciplinary teams preferred. 10-year experience in the pharmaceutical industry, drug regulatory authority may substitute for advanced degree.
  • Demonstrated ability to develop/maintain strong working relationships with the regulatory CMC team and cross functional teams, participate on and/or lead multi-functional teams, handle and prioritize multiple projects and work independently.
  • Comprehensive knowledge of drug development process, pharmaceutical technology, drug manufacturing processes, GMP and related issues.
  • Thorough knowledge of FD&C Act, 21 CFR, FDA and ICH Guidance’s, FDA policies and practices
  • Comprehensive knowledge and experience in preparing CMC (Quality) sections for investigational and marketed product submissions (IND, NDA, DMF) for FDA and equivalent submissions for Europe and Health Canada
  • Strong oral and written skills. Ability to identify, communicate and resolve complex issues.
  • Comprehensive understanding of the global regulatory environment.
  • Ability to assess and develop innovative ideas to optimize RA departmental processes and improve efficiencies, addressing current and future challenges.
  • Proficient in the tools and systems needed for the function including document management systems, regulatory information

 

Competencies

  • Inherent drive to cultivate collaboration, teamwork and professionalism
  • Ability to work independently, be an effective leader, and an engaged team member in a dynamic, fast paced, and lean environment
  • Nimble, creative, entrepreneurial with the ability to independently execute
  • Motivated to learn or advance own expertise and value
  • Systemically organizing and completing detailed tasks, checking accuracy and completeness of information
  • Highly attentive to detail and focused on quality
  • Results oriented and able to multi-task

 

Why joining POINT today will be the right career move for you:

There is no shortage of demand for smart, qualified and hardworking people like yourself – and we strongly believe POINT is the right career move for you. Here is why:

  • You will help establish and define an organization that will change the course of cancer therapies. and help thousands of people each year
  • You will be challenged, and are expected to challenge us, as part of a results-oriented, high performance team, where everyone leaves their egos at the door and lets the best ideas win
  • You will be provided the opportunity to participate in the financial value creation that occurs as POINT grows and becomes a mature pharmaceutical company
  • Most importantly, you will spend everyday working on something important

If what we are saying resonates with you, please submit a resume.

Benefits

  • Health Care Plan (Medical, Dental & Vision) - effective day 1
  • Retirement Plan (401k)
  • Income Protection Insurance – (Life AD&D, Short & Long-term disability) – 100% employer paid
  • Voluntary Income Protection – Premiums paid by employee
  • Paid Time Off (Vacation, Sick & Public Holidays)
  • $500 fitness reimbursement per year
  • $100 cell phone reimbursement per month

 

All applicants who are offered employment with POINT Biopharma will be subject to a background investigation. Offers of employment are contingent on the successful completion of a background investigation conducted in accordance with POINT Biopharma policy and state law.

POINT Biopharma does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.