Regulatory Affairs Manager
4 weeks ago
**Role is Fully Onsite to Northridge, CA**
ROLE SUMMARY
To support the our business in maintaining regulatory compliance of existing manufactured products for customers on a global basis by:
Managing regulatory compliance activities for us and our existing customer products and registrations as required and providing strategic planning for regulatory changes.
Acting as the regulatory lead for site-specific activities (e.g., Quality Reviews, Change Committees, etc.)
Co-ordinating and preparing regulatory documentation for clinical trial applications, Drug Master Files (DMFs), medical device technical documentation and registration CTD documents (where required).
Managing or mentoring more junior staff as required to achieve the business and role goals and objectives.
ROLE RESPONSIBILITIES
Management and Mentoring:
Providing input and direction to the site and wider Kindeva business on regulatory matters.
Providing regulatory support to team members as required on specific project issues ensuring alignment with global guidelines and legislation and the specific business needs.
Managing and/or mentoring members of the regulatory team as required.
Marketed Product and Manufacturing Site Support Duties and Responsibilities:
Advising internal and external stakeholders of the likely regulatory requirements associated with planned and unplanned changes made within the site and broader organization.
Participating in technical reviews of data within technical teams to ensure alignment with current global guidelines and to ensure data is generated to meet regulatory needs, responding to regulatory questions from wider technical teams.
Managing regulatory authority meetings as required including preparing briefing documentation and presentations.
Membership of project teams, including estimating regulatory resource needs for incorporation into project plans and monitoring of regulatory activities versus the project plan; reporting of issues / delays to management.
Attending customer focused meetings and interfacing with identified regulatory contacts at the customer company including preparing and reviewing presentations.
Communication of regulatory learnings from other projects. E.g., IND feedback, MAA project feedback, Pre IND meeting outcomes to ensure continuous improvement.
Advising on CMC elements of variation / supplement packages as required.
Communicating expectations of approval timelines within the organization.
Other Duties and Responsibilities:
Providing regulatory leadership for site-specific activities
Monitoring the developing and evolving global regulatory guidelines which impact the development and maintenance of medicinal products and providing assessments of the implications of the proposed legislation.
Recruiting, training, mentoring, motivating, and developing the team. Coaching and encouraging staff to be self-sufficient, to work actively with other departments and to become expert in their fields and where appropriate, to be active key members of project teams.
Ensuring continued personal development, identifying gaps, learning through doing and maintaining current knowledge of requirements for the role.
BASIC QUALIFICATIONS
Education:
Graduate in pharmacy or a life science (or equivalent).
Additional regulatory qualifications advantageous.
Experience:
12-15 years relevant experience of US, European or Global registration procedures (or significant experience in other areas of the pharmaceutical industry).
Knowledge:
In-depth knowledge of the Global Regulatory Affairs environment – Guidelines and legislation.
Deep practical knowledge of the drug regulatory processes in the US and background understanding of regulatory processes in other regions.
General understanding of drug development and pharmaceutical manufacturing from concept to launch including requirements for product development, manufacturing and marketing and the impact of regulatory changes on business goals/objectives. · Broad understanding of the pharmaceutical business in general and of other relevant associated regulatory areas (e.g., Clinical Affairs, Medical Devices, Chemicals Regulations, etc.).
Key Capabilities:
Able to communicate effectively orally and in writing.
Able to work both as part of a cross-functional team but also act independently. · Enthusiastic and determined to achieve set objectives.
Comfortable working with detailed technical information but also able to see the overall picture.
Possess strong computer skills and excellent organizational capabilities.
Demonstrate flexibility, strategic thinking and drive to succeed.
Be able to deliver results accurately within demanding time frames.
Able to handle a crisis in a professional and positive manner.
Able to communicate effectively with colleagues at all levels.
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