Regulatory Affairs Manager

Description

• Manage submissions and projects as assigned by Regulatory leadership assuring compliance, planning, and execution

• Represent regulatory on cross-functional teams

• Process, interpret and provide recommendations for complex strategies

• Provide regulatory and technical expertise to cross-functional teams

• Critically review documentation for regulatory submissions and provide input for necessary revisions

• Contribute to defining Target Product Profile and build compliant drug "approvable" dossiers and registration

• Serve as Liaison for third party service providers

• Maintain associated database for tracking individual and department project deliverables for regulatory submissions and milestones

• Develop and implement policies, procedures, practices, and strategies for Regulatory Affairs, based on current Health Authority guidelines and regulations

• Manage multiple, sometimes conflicting priorities, define issues and obstacles, define risk analysis and execute solutions

• Execute objectives in alignment with Regulatory leadership, Marketing, and Global Business Units

• Communicate regulatory governmental policy changes to management in a timely manner and provide plans for meeting and complying with new requirements. Understand and recommend strategies based on current local registration requirements and applicable industry standards

• Supports the professional development of regulatory staff through mentorship and guidance

• Present to upper management at required intervals and effectively communicate successes and challenges

• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.)

Additional Skills & Qualifications:

• Responsible for regulatory review of clinical documentation

• Authoring summaries/having very good skills in technical review of clinical summaries

• Knowing FDA requirements for electronic data sets going into module 5

• 8-12 years of industry regulatory experience

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email ~~~ (~~~) for other accommodation options.