Associate Director, Global Regulatory Affairs
Prefer Local Candidates (some onsite presence)
Will consider Remote
6 month contract
- Oversees as well as executes all regulatory activities of multiple projects, supports regulatory activities for assigned marketed product(s) of responsibility.
- Provides a regulatory strategic focus on non-clinical and clinical aspects of drug development and associated regulations.
- Serves as regulatory lead on the global development team (GDT) for individual project(s) of responsibility or delegates to staff with oversight.
- Collaborates with all company regions to ensure a global regulatory strategy is created and executed upon for all projects within projects of responsibility.
- Primary FDA contact for projects of responsibility or can delegate to staff with oversight.
location: Cambridge, Massachusetts
job type: Contract
salary: $100 - 130 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Working with EU co-lead (if applicable), leads the regulatory working team and represents team at GDT ensures global regulatory strategy written and executed according to plan or oversees if delegated to staff.
- Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports responsible.
- Responsible for independently achieving all submissions levels, including major submissions (NDA/BLA/MAA); may oversee staff in achieving major submissions.
- Accountable for ensuring all other regulatory submissions within the non-US. Americas territories are submitted on schedule by local company affiliates within project(s) of responsibility by ensuring the regulatory deliverables are provided as outlined in the global regulatory strategy.
- Oversee multiple projects and manager individual projects. For the project(s) of responsibility, collaborates with EU co-lean and/or other regional counterparts in the authoring of global regulatory strategies and ensures critical deliverables to territories outside the Americas to ensure regional execution of the strategy as agreed within the global regulatory strategy.
- Develop/author and execute global regulatory strategies for more complex strategies.
- May oversee execution.
- Executes day-to-day activities for projects .
- Identifies regulatory requirements and provides regulatory guidance, and expertise to global development team on the assigned project(s) of responsibility.
- Direct point of contact with health authorities.
- Lead and manage Agency meetings.
- Lead regulatory reviewer in due diligence for licensing opportunities.
- Identifies and proposes solutions to the management of for any resource gaps for areas of project responsibility.
- Provides oversight to ensure regulatory compliance of marketed products.
- Present to senior management as requested.
qualifications:
- BSc Degree preferred.
- Advanced Degree preferred.
- A minimum of 8 years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 8 years regulatory and/or related experience.
- Solid working knowledge of drug development process and regulatory requirements, knowledge of FDA, EU, Canada, ROW, and post-marketing a plus.
- Preferred experience in managing major regulatory filing(s); and significant contributor to regulatory and/or development strategies.
- Understands and interprets complex scientific issues across multiple projects as it relates to regulatory requirements and strategy.
- Generally strong in most and acceptable in all basic skill sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
- Generally strong in working well with others and within global teams; and acceptable at communicating with senior leadership.
- Generally strong and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
- Generally strong leader who is effective manager and is able to bring working teams together for common objectives, people management experience preferred.
skills: New Drug Application (NDA), Biologics License Application (BLA), Marketing Authorization Application (MAA), FDA Submissions, Global Regulatory Strategy Execution
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
