2 Manager, Regulatory Affairs Jobs in Plymouth Meeting, PA
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Braeburn is Hiring a Manager, Regulatory Affairs Near Plymouth Meeting, PA
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.
- 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.
- 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.
Job Summary
Full Time
Business Services
$134k-177k (estimate)
05/30/2024
06/29/2024
braeburngroup.net
LAVEEN, AZ
100 - 200
Private
$10M - $50M
Business Services
Related Companies
The job skills required for Manager, Regulatory Affairs include Regulatory Affairs, Initiative, Collaboration, Innovation, Product Development, Written Communication, etc. Having related job skills and expertise will give you an advantage when applying to be a Manager, 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 Manager, Regulatory Affairs. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Manager, Regulatory Affairs positions, which can be used as a reference in future career path planning. As a Manager, Regulatory Affairs, it can be promoted into senior positions as a Regulatory Affairs Senior Manager that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Manager, Regulatory Affairs. You can explore the career advancement for a Manager, Regulatory Affairs below and select your interested title to get hiring information.
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