Senior Manager, Regulatory Affairs
Location
United States
Posted
16 days ago
Salary
$149.9K - $181.6K / year
Seniority
Senior
Bachelor Degree5 yrs expEnglish
Job Description
• Global Regulatory Lead for a cutting edge RPT programs
• Clinical and nonclinical regulatory strategy for therapeutic and diagnostic (imaging) products, including timing and nature of global regulatory interactions.
• Authoring of regulatory documents that are required for regulatory interactions.
• Keeping up to date in the relevant disease areas, including anticipating changes in standard of care as perceived by regulatory authorities and other key customers.
• Maintaining an expert knowledge of the relevant regulatory landscape.
• Maintaining a relationship with and representing the company to regulators.
• Lead the preparation and submission of regulatory filings (e.g., IND, IND amendments, CTA/IMPD, annual report, briefing document, iPSP/PIP, safety reports, marketing applications).
• Lead the preparation for Health Authority Interactions.
Job Requirements
- Bachelor’s degree or higher
- 5 or more years of hands-on regulatory experience
- Experience with therapeutic and diagnostic (imaging) radiopharmaceutical product development and familiarity with radioisotopes such as 68Ga, 177Lu, 225Ac, 161Tb, F18, Y90, etc.
- Experience with nonclinical and clinical regulatory strategy in oncological indications
- Demonstrable record of strong leadership and teamwork in a cross-functional, fast-paced industry environment
- Excellent written and verbal communication skills.
- Highly organized, with the ability to multi-task and handle pressure well
- Meticulous with detail and precision
- Ability to think through a project or task of diverse complexity and execute independently from beginning to end
- Fully proficient in MS Office (Outlook, Word, PowerPoint, Excel, and Teams) and video conferencing
- Strong communication and interpersonal skills
- Should be assertive, proactive, professional, and confident
- Excellent professional ethics and integrity
- Flexibility to adapt in a cross-functional and dynamic environment
Benefits
- Health Coverage: Medical, pharmacy, dental, and vision care.
- Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
- Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
- Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
Related Guides
Related Categories
Related Job Pages
More Compliance Jobs
Manager, Clinical Regulatory
Vera Therapeutics, Inc.We are a clinical-stage biotechnology company developing treatments that transform patients’ lives.
Compliance16 days ago
Full TimeRemoteTeam 201-500H1B No Sponsor
Manager, Clinical Regulatory managing regulatory submissions in clinical-stage biotech.
Vault
Regulatory Publishing Manager – Contract
Vertex PharmaceuticalsVertex Pharmaceuticals is a global biotechnology company dedicated to commercializing breakthrough drugs and improving the lives of people with serious diseases
Compliance16 days ago
ContractRemote
Regulatory Publishing Manager supporting document-level regulatory publishing activities
Vault
United States
Associate Director, Regulatory Publishing
Vertex PharmaceuticalsVertex Pharmaceuticals is a global biotechnology company dedicated to commercializing breakthrough drugs and improving the lives of people with serious diseases
Compliance16 days ago
ContractRemote
Associate Director leading Regulatory Publishing activities for Vertex Pharmaceuticals
United States
Compliance16 days ago
Full TimeRemoteTeam 10,001+H1B No Sponsor
IFM Operations & Compliance Team Lead overseeing facilities operations at JLL
