38 Associate Director, Regulatory Affairs Jobs in Boston, MA
Monte Rosa Therapeutics is Hiring an Associate Director, Regulatory Affairs Near Boston, MA
- The Associate Director of regulatory Affairs will be responsible for the development and execution of the Regulatory strategy for assigned programs in alignment with the corporate goals.
- Oversee the preparation, submission, and maintenance of regulatory applications, including INDs, CTAs, marketing applications, Annual Reports, Orphan Drug Designation, Requests for Fast Track, and other regulatory documents.
- Lead and manage FDA and Health Authority interactions with FDA and global health authorities, including meetings, teleconferences, and written correspondence.
- Ensure compliance with global regulatory requirements and guidelines, including FDA, EMA, and other regulatory authorities.
- Represent Regulatory on cross-functional product team and provide strategic regulatory guidance and support to achieve product development objectives.
- Collaborate with internal and external stakeholders, manage and oversee third-party vendors and consultants to ensure high-quality submissions, and successful execution of regulatory strategies.
- Responsible for the maintenance of regulatory files and database, tracking regulatory commitments, and supporting the development of processes, SOPs, work instructions, and other controlled documents.
- Maintain working knowledge of laws, guidance, and requirements to assigned programs, in addition to general regulatory knowledge.
- Additional duties and responsibilities as required.
- Bachelor's degree in health sciences or related field, or an advanced degree is preferred
- Minimum of 12 years of experience in global regulatory affairs within the pharmaceutical or biotechnology industry
- Hands-on experience in managing the preparation and timely submission of regulatory applications, such as US IND or CTA, is required. Regulatory expedited program submissions, CMC, and EU CTA experience is a plus
- In-depth knowledge of global regulatory requirements, guidelines, and processes for drug development and approval
- Strong computer skills, including knowledge of Excel, Word, PowerPoint, Outlook, and MS Project/Smartsheet.
- Experience with managing third-party vendors, regulatory operations, and consultants is a plus.
- Ability to build and maintain effective working relationships with internal and external stakeholders.
Job Summary
Full Time
$181k-240k (estimate)
06/27/2024
07/25/2024
monterosatx.com
Brighton, MA
<25
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The job skills required for Associate Director, Regulatory Affairs include Regulatory Affairs, Product Development, Biotechnology, Drug Development, Oncology, SOP, etc. Having related job skills and expertise will give you an advantage when applying to be an Associate Director, Regulatory Affairs. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Associate Director, Regulatory Affairs. Select any job title you are interested in and start to search job requirements.
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