Boston, Massachusetts
Associate Director of Regulatory Affairs Job Opening in Boston, Massachusetts - In this Regulatory Affairs role, the RA Associate Director is responsible for managing the development and submission of regulatory packages to US and global regulatory authorities for products within the company?s pipeline. The RA AD will also play an essential role in the development of US and global strategic planning to support product development milestones.
Duties & Responsibilities
The successful candidate will:
Lead interactions and submission filings with local / regional regulatory authorities including US IND applications, clinical trial applications, and special designation packages
Participate in and support development of meeting packages for regulatory meetings with relevant regulatory authorities
Ensure flexibility in defining and executing regulatory pathways for novel products to treat serious diseases in the US and globally
Communicate strategic regulatory advice to cross-functional teams in support of drug development plans in consideration of global development requirements
Support regulatory plans for pediatric drug development
Manage regulatory supportive vendors and global liaisons
Ensure compliance with regional requirements at all stages of product development
Assist with development and implementation of policies and standard operating procedures (SOPs) to be used in Regulatory Affairs
Qualifications & Skills Education and Experience:
BA/BS (preferably in industry or healthcare of science field) with 3-5 years progressive experience in a Regulatory Affairs role
Must have thorough understanding of US FDA regulations and FDA and ICH guidelines
Ability to handle a high volume of complex tasks within a given timeline
Ability to lead a cross-functional team in a matrix environment
Experienced in regulatory authority interactions
Strong verbal and written communication and presentation skills
Proactively seeks out and recommends process improvements
Manufacturing and/or compliance experience desired but not required
Experience in serious disease therapeutic areas desired but not required
Job Type: Contract
Salary: $150,000.00 /year
Job Location:
Boston, MA
Required education:
Bachelor's
Required experience:
Regulatory Affairs: 3 years
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