Manager, Regulatory Affairs

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Job description

Job Description

At Viral Vector Services (VVS), a division of Thermo Fisher Scientific we deliver, from process development through commercial supply, we offer the expertise and resources necessary to help clients deliver innovative gene therapies. Placed in the forefront of our leading- and cutting-edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.

How will you make an impact?

Through supporting on-site inspections with regulatory authorities from around the world, participate in regulatory intelligence gathering, and partnering with VVS clients to ensure accurate and timely submissions, the incumbent will help shape healthcare by improving patient access to novel therapeutics.

What will you do?

The incumbent will be provided with appropriate procedures and access to experienced thought leaders in Regulatory Affairs through direct meetings with the VVS Head of Regulatory Affairs, Global Regulatory community of practice meetings, and access to professional Regulatory Affairs organizations, such as BioPhorum and the Parental Drug Association.

* Maintain VVS regulatory submissions (e.g. site master files and drug master files) and escalate potential risks during review and data verification processes to the applicable Quality and Operational Site Head and to the VVS Head of Regulatory Affairs
* Support and coordinate responses to requests from regulatory authorities
* Interacts with clients and regulatory authorities for VVS regulatory inquiries, as applicable
* Remains current with regulatory intelligence and ensures VVS submissions are aligned with current standards/expectations
* Demonstrate expert knowledge of submission or technology-related global Health Authority guidelines/regulations
* Provide guidance and Compliance oversight for any Recalls, Complaints, and Regulatory Reporting
* Develop options for Quality Strategy and intelligence
* Provide up-to-date thinking and functional insight to VVS by actively engaging in the appropriate external Quality organizations and associations
* Manage the day-to-day submission responsibilities including the overall planning and management of regulatory operations resources to effectively support VVS' timely and quality submissions to global regulatory authorities
* Develop and implement and maintain VVS regulatory submissions (e.g. site master files, drug master files)
* As required, partner with clients to provide information as necessary to support their regulatory filings
* Manage cross-functional teams in response to client regulatory queries and regulatory submissions and requests from regulatory health authorities.
* As required, manage contractors/service providers who support Regulatory submissions goals
* Effectively communicate with Program Managers on the status, objectives, risks, and mitigation plans associated with the various regulatory projects, as well as ensure regulatory teams are aware of current integrated program timelines

How will you get here?

Education

* Bachelors or master's degree in life sciences or business management preferred

Experience

* 5 + years of Regulatory Affairs experience, preferably with major marketing application experience, preferably in biotechnology and CDMO
* Proven ability to successfully plan for and manage new regulatory submissions while overseeing the routine daily maintenance of existing regulatory applications
* Successfully manage regulatory submissions projects, such that they integrate effectively with the overall objectives of the programs they support
* Ability to motivate and influence without line-management authority
* Ability to supervise cross-functional teams
* Working experience with regulatory processes and systems; particularly those employed in EU, US and Japan

Knowledge, Skills, Abilities

* Excellent organizational skills and attention to detail and accuracy excellent communication, analytical, and organizational skills
* Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
* Ability to embrace change and multi-task in an extremely fast-paced environment
* Exhibits strong communication, leadership and planning skills with the ability to work effectively with a wide range of constituencies in a diverse community

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit .