Manager Regulatory Affairs CMC (Biologics Products) - Remote / Telecommute

03 May 2024

Vacancy expired!

We are looking for

Manager Regulatory Affairs CMC

(Biologics Products)

- Remote / Telecommute for our client in

Jersey City, NJ

Job Title:

Manager Regulatory Affairs CMC

(Biologics Products)

- Remote / Telecommute

Job Location:

Jersey City, NJ

Job Type:

Contract

Job Description:

Pay Range $55hr - $60hr
  • Inviting applications for the role of Senior Manager (SM) Regulatory Affairs CMC (Small molecules).
  • SM of Regulatory Affairs CMC, small molecules, is responsible for developing and implementing CMC regulatory strategies for all assigned products with the intention of achieving successful registration and life-cycle management.
Responsibilities:
  • Deliver regulatory CMC strategic leadership to support development and regulatory approval of multiple innovative products, mainly small molecules, for a wide variety of therapeutic areas and dosage forms.
  • Lead project related regulatory CMC activities in a matrix structure.
  • Manage and implement planning, preparation, and submission of high-quality CMC related applications with a focus on the US and EU/EMEA regions.
  • Ensure that CMC-related applications and/or sections, including IMPDs/INDs, investigator brochures, scientific advice requests, agency briefing documents, and MAAs are complete, well written, and meet all relevant requirements.
  • In collaboration with the Regulatory Strategy Leads, coordinate negotiations on CMC topics with regulatory agencies to resolve CMC issues.
  • Effectively communicate regulatory CMC strategy to Regulatory Strategy leads and other internal stakeholders.
  • Drive adherence to CMC regulatory guidelines relevant for the development of biologics.
  • Assess proposed manufacturing process changes and provide strategic regulatory guidance to enable global implementation.
  • Assess the impact of new regulations, guidance and directives and advise the regulatory organization on requirements to maintain compliance with regulatory operations activities.
  • Manage post approval changes where needed.

Job Requirements:
  • Prior experience and a successful track record within the biotechnology and/or pharmaceutical industry in successful preparation and submission of IMPDs/INDs, Scientific Advice, MAAs, post-approval life cycle management for mainly small molecule products.
  • Experience with medical device and combination products would be advantageous.
  • Strong knowledge of current Good Manufacturing Practices (GMP), drug (and biologics) development regulations and guidelines including ICH, EMA and FDA guidelines.
  • Strong leadership qualities including strategic thinking, innovation, people management, project management and excellence in communication.

Qualifications:
  • This position requires a self-motivated and organized individual with the ability to exercise flexibility, and solution focused decision making.
  • The successful candidate should be self-motivated and well organized.
  • Master’s degree in life sciences in biochemistry, chemistry, biology, or related pharmaceutical fields; higher degree, such as a PhD is desirable.
  • At least 12 years of relevant biopharmaceutical industry experience, with at least 10 years’ experience in the regulatory CMC area (mainly dealing with small molecules).
  • Prior experience in big (or mid-size) Pharma companies.
  • Proven project management delivery
  • Robust communication and presentation skills.
  • Proven track record in working cross-culturally.

  • ID: #49850862
  • State: New Jersey Jerseycity 07097 Jerseycity USA
  • City: Jerseycity
  • Salary: Depends on Experience
  • Job type: Contract
  • Showed: 2023-05-03
  • Deadline: 2023-07-01
  • Category: Et cetera