Regulatory Affairs Manager

Job Title: Regulatory Affairs Manager

Location: Fully remote (east coast candidates preferred)

Remote Flexibility: Yes

Targeted Start Date: June 3rd

Contract Term: 4 month contract and a chance to be extended up to 6 months (target end date of 10/4)

Hours: 40 hours per week

Why is the position open?: Assistance while FTE is on leave

Experience required:

• Oncology experience
• Regulatory strategy experience required
• Past experience working with mid-size to large companies
• Prioritize candidates with EU-CTR experience - required
• Managing submissions

Regulatory Affairs Manager

• Be accountable for the execution of regulatory strategies including, but not limited to, compiling regulatory submissions such as IND, CTA, Amendments, and support major submissions such as (s)NDA, MAA, variations, etc.
• Act as the conduit between cross-functional study teams and Regulatory Operations to ensure timely execution of assigned submissions
• Lead Regulatory initiatives including Regulatory Intelligence and Regulatory Science projects, compliance activities, and assigned tasks
• Maintain Regulatory Strategy Documents for assigned programs
• Co-chair Regulatory Sub team with the Global Regulatory Lead
• Accountable for submissions such as Annual Reports and Renewals for assigned products

Qualifications:

• Bachelor’s degree in a life science concentration
• 2+ years of experience with a Regulatory Affairs Postgraduate degree or 5+ years of experience in progressive Regulatory Affairs roles
• Experience in oncology preferred
• Good understanding of legislations, regulations and policies that govern drug approvals and commercialization in the US, and preferably in the EU as well
• Demonstrate a strong understanding of relevant regulatory guidance documents that pertain to oncology drug development
• Excellent command of verbal and written English and careful attention to detail
• Ability to work with cross-functional teams and ability to work on several projects at once while balancing multiple and overlapping timelines
• Proficient in the use of Microsoft Office, Adobe Acrobat, and SharePoint software.
• Skillset: preferred oncology experience, working with mid-size to large companies in the past, ability to work on competing priorities, EU-CTR experience

Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.

If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser: https://jobs.beaconhillstaffing.com/eeoc/

Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records.

Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.

If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser: https://jobs.beaconhillstaffing.com/eeoc/

Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records."