Looking for a Sr Regulatory Affairs manager that will be managing 2-3 regulatory affairs specialists. This candidate can be anywhere on the East Coast to be able to work remote.
Represent Regulatory Affairs on assigned product/ project teams to communicate regulatory strategy and plans to gain alignment with team members, line management, and multiple stakeholders, including funding agencies
- Develop innovative regulatory strategies that incorporates risk identification and mitigation
- Lead the preparation, planning and execution of aligned regulatory strategy through timely regulatory submissions
- Oversee development of submission content, documents and timelines
- Provide critical review of all documentation supporting regulatory applications, provide gap analysis of submissions based on regulatory requirements; anticipate Health Authority responses and communicate areas of risk to project teams and line management
- Lead meetings both in-person and teleconferences with regulatory agencies for specific projects
- Negotiate complex issues with regulatory agencies and prepare responses to questions and comments from regulatory agencies
- Ensure regulatory product compliance for assigned products (e.g. agency commitments)
- As required, provide regulatory assessment for deviations, change controls and manage associated regulatory activities to ensure compliance
- Maintain awareness of new and developing legislation, policy and technical regulatory guidance relating to assigned programs. Interpret existing regulations and guidance documents for regulatory department and/or project teams. Conduct and analyze regulatory research to understand competitor activity
- Interact with company partners and consultants for various regulatory matters as needed
- As required, develop procedures to support the regulatory affairs department
- May provide input to business unit strategies from regulatory perspective
- Will be responsible for a functional area and/or have direct reports
regulatory, BLA, regulatory affairs, pharmaceutical industry, biotechnology, medical, Biologics, FDA, EMA, Regulatory agencies, Cross functional, Mentor
Top Skills Details:
1) Management or Supervisor
Additional Skills & Qualifications:
- Bachelor's degree in a life sciences or related discipline required. Approximately 10+ years of relevant pharmaceutical industry experience, with minimum 8 years in Regulatory Affairs. Less experience acceptable for suitable candidates with relevant industry experience and skill sets.
- Must have experience interacting with the FDA, EMA, Health Canada and/or other regulatory agencies
- Ability to work on problems of diverse scope
- Identifies priorities and key issues in complex situations and solves with minimal assistance
- Exercises judgement within generally defined regulatory practices and policies
- Experienced in leading cross-functional interactions (CMC, Clinical and Nonclinical) related to regulatory matters
- Ability to guide, train, supervise and mentor personnel within the regulatory affairs team
- Effective in both written and oral communication
- Is able to direct work as required and manage complexity
- Ability to anticipate and prevent potential issues
- Understanding of regulatory issues and their touch points
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.