VP/Sr. Director, Regulatory Affairs

Job Description

Creating and executing regulatory development plans and manages timelines to achieve the stated goals

Interface directly with governmental personnel, including scientific reviewers, administrative support and management to facilitate the review and approval of regulatory applications

Work closely within the department and across the project team to ensure that all activities are conducted in compliance with relevant laws, regulations, and guidance. Ensure clear communication of project activities and progress in a timely manner

Preparation and submission of required documents to regulatory agencies with an emphasis on pre-IND, IND, and Phase II submissions. Ensure submissions are complete, properly formatted, and comply with applicable regulatory requirements

Ensure in concert with the Sr. Director of QA that appropriate documentation is maintained to record regulatory decisions for the projects

Familiar with a variety of field concepts, practices, and procedures

Assist in developing procedures to ensure regulatory compliance

Contribute CMC writing for FDA, EMEA, and MHRA submissions including INDs and CTAs

Develop and implement innovative regulatory strategies for development projects

Manage the planning and coordination of productive and effective regulatory submissions and regulatory agency meetings

Monitor and analyze regulatory agency activities and advice the Director of RA & Operations on appropriate action

Build and maintain excellent relationships with regulatory authorities

Serve as a responsible contact with regulatory authorities and corporate partners

Performs functional activities of Clinical Supply Manager and performs project management activities from a clinical supplies perspective

Leads the planning, creation, and maintenance of project plans, based on study forecasts

Accountable for the scheduling and timely delivery of packaged clinical trial material and study design, including randomization and the packaging, labeling, and international distribution of clinical supplies

Ensures that key project milestones are met; negotiates and communicates supply plan timelines to internal and external customers and partners

Proactively drives cross-functional activities. Works with other line functions and external partners to manage complex projects

Performs supply forecast simulations to determine optimal supply quantities and manufacturing/packaging campaigns, contributes to the design specifications for studies, and provides medication management for highly complex studies

Establish and manage cGMP facility for labeling, packaging, and distribution of clinical product for international trials

Write SOPs for GMP, GLP, and GCP processes


Master's Degree in chemistry, biology, or life sciences field

PhD or Pharm.D a plus, or equivalent experience

10-15 years experience in regulatory affairs providing regulatory guidance in the development of drugs and/or post-marketing support of drugs and relevant experience in
Pharmaceutical Development, Clinical Development, Clinical Study Operations, or Project

Management with a heavy focus on Clinical Supply Planning and Management

Working knowledge of FDA organization, regulations and guidance documents.

Knowledge of regulations pertaining to global regulatory agencies

Experience and knowledge in preparation of INDs, NDAs, MFs, and supportive amendments of supplements

Must have knowledge of GMP regulations as well as an understanding of the pharmaceutical product life cycle

Demonstrated ability to manage multiple assignments, appropriately identify and resolve regulatory issues, and communicate as needed to management

Demonstrated ability to work independently and manage multiple projects within cross-functional teams

Strong negotiation, communication, and interpersonal skills and ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff

Demonstrates strong knowledge of regulations, guidelines, and precedents related to drug product development, labeling, and promotion

Proven track record of successful interaction with regulatory authorities

Demonstrated ability to lead organizational change and innovation

Proven ability to impact and influence the decisions of a team, decision-making committees

Management/leadership skills

Demonstrates working knowledge of clinical supply systems and specialized tools

Advanced knowledge of development activities and processes

Advanced project management skills

Ability to work in interdisciplinary teams

Strong knowledge of relevant GxPs as well as applicable multinational regulations

Excellent organization, planning, communication, negotiation, and interpersonal skills
Good leadership skills


Insmed Inc.

Job Code

State or Province

New Jersey

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