Manager, Regulatory Affairs

POSTION SUMMARY

The Manager, Regulatory Affairs provides support pertaining to regulatory affairs related to the development of novel drugs including preclinical and clinical areas of drug development and the policies/procedures required to ensure compliance with regulations.

JOB FUNCTIONS/RESPONSIBILITIES

• Leads preparation of regulatory documentation, in accordance with regulations, guidance and legal obligations.
• Supports the GRL and cross functional teams on major submissions such as NDA and MAA submissions, and supplemental applications, as well as preparation for meetings with Regulatory Authorities.
• Prepares and/or co-ordinates the regulatory documentation required for global clinical trial applications and amendments.
• Interacts with the Regulatory, Clinical Development, Clinical Operations and other functions to ensure optimal execution of the agreed regulatory strategy for development medicinal products.
• with the GRL, contributes to the development of global regulatory strategy to support the conduct of global clinical studies as well as the development of global regulatory strategy for the submission and approval of US and ex-US marketing applications, including in the EU.
• Manages interactions with Regulatory consultants and contract research organizations, as needed.
• Represents Regulatory Affairs on cross-functional submission and study management teams. May also represent Regulatory Affairs on other cross-functional teams.
• Responsible for maintaining a working knowledge of US and EU regulatory requirements and guidelines and for communicating changes in regulatory information to product teams.
• Oversees drafting, finalization and submission of product prioritization designation requests, pediatric plans and pre-meeting packages to FDA and EMA.
• Works with medical writing to manage document preparation timelines and communicates with team members to maintain awareness of expectations, to enable timely reviews, achieve milestones and document deliverables.
• Archives and tracks ongoing submissions.
• Works directly with the electronic publisher to get submissions published.

QUALIFICATIONS

Education/Experience:

• Degree in biological or life sciences, pharmacy or medicine (or international equivalent). An advanced degree is desirable with a minimum of 5 years in the pharmaceutical industry or relevant work experience and a minimum of 3 years in Regulatory Affairs.
• Experience in the preparation and submission of regulatory documentation to support Agency review/approval procedures, post-approval activities, and breadth of understanding of FDA and EMA regulations and procedures (additional international expertise is a plus).
• Experience representing Regulatory Affairs on cross functional teams.
• Excellent planning and organizational skills and the ability to work simultaneously on multiple projects with tight timelines.
• Excellent communication skills, both in writing and verbally.

Knowledge, Skills and Abilities:

• Ability to work under minimal supervision while following defined procedures.
• Plans and prepares complex regulatory documents for US and ROW submissions with minimum supervision.
• Plans and implements regulatory activities that support lifecycle management.
• Has regulatory expertise and extensive knowledge of regulatory requirements and regulations with ability to strategically interpret and communicate requirements.
• Ensures that teams and functional groups are provided with clear, constructive regulatory advice and intelligence to assist planning and issue resolution.
• Knowledge and experience relating to clinical trials.
• Develops collaborative relationships cross-functionally and within Regulatory Affairs to facilitate the accomplishment of work goals without relying on authority.
• Strong desire to learn and grow as a Regulatory Professional.
• Forward thinking and proactive approach to work.

Work Environment:

• Willingness and ability to travel domestically and internationally is required, it is anticipated that this will be 5% of work time.

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