Senior Regulatory Affairs Manager

Job Description:

The Senior Regulatory Affairs Manager manages assigned regulatory and cross-functional projects; provides strategic and operational support to Veristat clients in regulatory decision making processes, filings and maintenance of healthcare products and plays a key role in providing consultation to Veristat’s clients, in translating regulatory requirements into practical application to ensure the success of clinical trials and regulatory submissions. S/he will work with project teams, provide advice on regulatory agency interactions, manage agency communications, support the preparation of submissions, and create strong rapport with clients.

Make an Impact at Veristat!

Join a global team with more than 30 years of expertise accelerating life-changing therapies to patients worldwide.

• 105+ approved therapies for marketing applications prepared by Veristat
• 480+ oncology projects in the past 5 years
• 350+ rare disease projects delivered in the past 5 years
• Flexible, inclusive culture — 70% remote workforce, 66% women-led teams

Learn more about our core values here!

What we offer

• The estimated hiring range for this role is $125K-160K plus applicable bonus. This hiring range is specific to the US and will vary for other regions based upon local market data.  Final salary is ultimately decided upon taking into account a wide range of factors, including but not limited to: skills and experience, licensure and certifications, education, specific location and dynamic market data.
• Benefits vary by location and may include:

o   Remote working

o   Flexible time off

o   Paid holidays

o   Medical insurance

o   Tuition reimbursement

o   Retirement plans

What we look for

• Bachelor’s degree in a related field required. Advanced scientific degree (i.e. PhD or Master’s degree) preferred.
• 6 - 8 years of regulatory affairs experience in a clinical research organization and/or pharmaceutical setting (or demonstrated ability to function at this level), with a proven track record of global regulatory submissions
• As Senior Manager Regulatory Affairs CMC: familiar with manufacturing, specifications, analytical testing and overall regulatory CMC requirements
• Thorough knowledge of International Conference on Harmonisation (ICH) guidelines and regulatory guidelines in the relevant territories as well as drug development, clinical trials, and clinical research
• Excellent written and oral communication skills including grammatical/technical writing skills, and familiarity with drug development, agency interactions, study designs and regulatory requirements that apply to clinical trials are required
• Demonstrated ability to develop and foster positive client relationships.
• Demonstrated ability to lead by example and demonstrated skill for technical leadership of staff.
• Skilled in use of computer software, including Microsoft Word and Microsoft Excel, and ability to learn new applications.
• Excellent interpersonal, communication, and organizational skills with the ability to work independently and in a team environment.

All applicants are reviewed by a member of the Veristat Talent Acquisition team; Veristat does not utilize an automated decision-making process.