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REMOTE - Director, Regulatory Strategy (Biologics)

Company: Resilience Boston, Inc
Location: Boston
Posted on: September 16, 2021

Job Description:

Insight Global is looking for a Director, Regulatory Strategy (Biologics) to join a new upcoming and heavily growing Biotechnology Company in the Greater Boston Area! Over 1 billion dollars was fundraised by the C level executives to continue growth and production of this company. This company is being called the Amazon of the Biotech world due to its innovative business and how fast in growth they are. There will be another 6 GMP facilities up and running within the next 1-2 years with a few already being finalized. This person will be fully remote with minimal travel required. This person will head the Biologic regulatory strategies to continue the mission of building a network of high-tech, end-to-end manufacturing operations and development solutions across multiple drug product modalities. This will be responsible for the product development plans, regulatory submissions, reviews, and regulatory authority communications. The role is responsible for building and maintaining an excellent working relationship with the FDA and other relevant US government stakeholders. The Director, Regulatory Strategy is a key leadership role and reports to the Vice President, Regulatory Strategy. This company is growing rapidly and this individual will be joining at a time where they can help mold and formulate the structure and culture of this company!

Bachelors degree in a scientific discipline

Minimum of 15 years of pharmaceutical industry experience, with minimum of 7 years in a Regulatory CMC role; experience in biologics development is required

Demonstrated, hands-on experience in drug development CMC, registration, and post-approval life cycle management in a global regulatory environment

Excellent knowledge of the regulations for biologics products

Experience with drug product manufacturing facility licensure

Ability to understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy

Demonstrated experience in preparing regulatory submissions and response to health authorities queries

Ability to influence without direct authority

Keywords: Resilience Boston, Inc, Boston , REMOTE - Director, Regulatory Strategy (Biologics), Other , Boston, Massachusetts

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