Manager, Regulatory Affairs
1 month ago
Location: Remote
Company Overview:
Braeburn is dedicated to delivering solutions for people living with the serious consequences of opioid use disorder. At Braeburn, we challenge the status quo and champion transformation of the management of opioid use disorder (OUD) by partnering with the community to create a world where every person with OUD gets the best possible care and opportunity to reach their full potential. Our shared commitment to innovation on behalf of patients enables us to help people with OUD begin and sustain recovery.
At Braeburn, there are opportunities to contribute to our purpose every day. We value authenticity and strive to amplify all voices. Our culture empowers everyone to be successful and unleashes our full potential.
Position Summary:
The Manager of Regulatory Affairs will be responsible for the implementation of regulatory activities that support the success of products throughout their lifecycle. The individual will work closely with cross functional departments to prepare, write, review, and submit regulatory filing documents, in addition to managing documentation systems.
The individual in this growing department must be able to prioritize submissions and/or projects and pivot according to business needs and/or broader initiatives that align with the company's purpose, culture, and core values.
Specific Duties:
•Drive the preparation and review of regulatory submissions (NDAs, INDs etc.) and supplemental filings, including interfacing with other departments to obtain the necessary components and reports.
•Develop and optimize detailed regulatory project/submission plans and timelines in collaboration with various leads.
•Identify and highlight project interdependencies.
•Prepare and write eCTD sections including clinical overviews, clinical summaries, briefing documents, and responses to information requests, ensuring regulatory documents are written per regulatory agency guidelines.
•Assist in the development and preparation of CMC submission documentation.
•Ensure that all documents to be submitted to regulatory agencies are complete, properly organized, scientifically accurate, compliant, and are presented in a way that facilitates agency review.
•Represent Regulatory Affairs in cross-functional team projects to support clinical trials and registration activities, as needed.
•Maintain regulatory filings or records, including the archive of submissions and correspondence files.
•Monitor emerging trends regarding industry regulations and maintain awareness of evolving regulatory requirements and developments.
•Review and assess change control activities for potential impact on current regulatory filings.
•Evaluate and develop standard operating procedures for the Regulatory Affairs department.
Skills:
•Strong working knowledge of U.S. regulatory requirements.
•General understanding of drug development and pharmaceutical manufacturing from concept to launch, including requirements for product development, manufacturing, and marketing.
•Excellent organization, and verbal/written communication skills.
•Ability to handle multiple priorities simultaneously while generating quality output.
•Self-motivated and highly collaborative but can work independently as well.
Education/Experience:
•Bachelor's degree, preferably in a scientific discipline.
•3+ years of relevant experience in the bio/pharmaceutical industry.
•Working knowledge of Veeva Vault systems preferred.
Braeburn is committed to ensuring equal employment opportunity for all qualified applicants regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, military/veteran status, age, disability, or any other category/characteristic protected by law (collectively, "Protected Categories"). In fact, we encourage all underrepresented backgrounds to apply for any open job positions with the company.
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