Manager Regulatory Operations - Bridgewater, United States - Insmed Incorporated

Insmed Incorporated Bridgewater, United States

2 weeks ago

Description

Company Description:

Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.

Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.

Recognitions:

Named Sciences Top Employer in 2021, 2022, and 2023

Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. Thats why we were named the No. 1 company to work for in the biopharma industry in Sciences Top Employers Survey for two years in a row.

A Certified Great Place to Work

We believe our company is truly special, and our employees agree. In July 2023, we became Great Place to Work-certified in the U.S. for the third year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma, Best Workplaces in New York, and Best Workplaces for Millennials lists.

Overview:

The Manager, Regulatory Operations will be responsible for functional activities related to US/Ex-US regulatory submissions. In addition, this individual will be responsible for general document management activities relating to the archiving of submission and submission related documents in the Companys electronic document management system (EDMS).

Responsibilities:

RESPONSIBILITIES:

Support regulatory submission activities associated with generating electronic submissions in support of IND/NDA applications.
Responsible for the archival of submission and submission related documents in the EDMS
Contribute to submission planning to identify pending submissions and define priorities.
Anticipate upcoming tasks based on the submission timelines.
Perform quality control checks and coordinate comment resolution with publishing team.
Support authors to complete regulatory documents such that all components are provided and presented in the correct format.
Manage document review and approval as needed.
Assists with other projects to support the regulatory department as assigned.
Provide support in software validation and migration activities relating to new or existing systems in Regulatory Affairs

Required Skills

5 years of Regulatory Operations experience
Extensive knowledge and experience with Microsoft Office, Adobe Acrobat, Veeva RIM, DocuBridge eCTD Publishing software, DXC Toolbox, WebTrader, Extedo eSubmanager
Effective/productive working with minimal supervision
Detail oriented
Strong written and verbal communication skills
Ability to multitask and prioritize when working on multiple projects and deliver on tight timelines within a fast-paced team environment.
Flexible in managing shifting priorities.

Travel Requirements:

10%

Salary Range:
Insmed takes into consideration a combination of candidates education, training, and experience as well as the positions scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary level for potential new employees.

The base salary range for this job is from $116,000.00 to $161,333.00 per year

Compensation & Benefits:

Were committed to investing in every team members total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including:

Flexible approach to where and how we work, regionally based
Competitive compensation package including bonus
Stock options and RSU awards
Employee Stock Purchase Plan (ESPP)
Flexible Vacation Policy
Generous paid holiday schedule and winter break

ADDITIONAL U.S. BENEFITS:

401(k) plan with company match
Medical, dental, and vision plans
Company-provided Life and Accidental Death & Dismemberment (AD&D) insurance
Company-provided short and long-term disability benefits
Unique offerings of pet, legal, and supplemental life insurance
Flexible spending accounts for medical and dependent care
Accident and Hospital Indemnity insurance
Employee Assistance Program (EAP)
Mental Health on-line digital resource
Well-being reimbursement
Paid leave benefits for new parents
Paid time off to volunteer
On-site, no-cost fitness center at our U.S. headquarters

Additional Information:

Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

Applications are accepted for 5 calendar days from the date posted or until the position is filled.

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