Job Description

About the Company

A world leader in developing and commercializing innovative biopharmaceuticals for rare diseases driven by genetic causes. Throughout, we’ve worked tirelessly to make a difference by pursuing bold science while respecting, educating, and connecting with patients. Through our expertise in genetics and molecular biology, we have been able to develop targeted therapies that address the root cause of the exact conditions we seek to treat. Our discoveries have led us to countless breakthroughs, best-in-class treatments and many ‘firsts’ in the category. We are grateful to able to better the lives of those struggling with genetic diseases. As we look forward, we strive to make an even greater impact by applying the same science-driven, patient-forward approach to a broader range of genetic disorders.

About the Role

There are two roles available. Manager and a Sr. manager Regulatory affairs.

Pay rate commensurate with experience.

Remote but PST candidates only.

Responsibilities

• Global Regulatory Affairs (GRA) is responsible for obtaining approval for new products and ensuring that approval is maintained throughout the product lifecycle. GRA serves as the interface between the regulatory authorities and the program teams aiming to ensure that the project plan correctly anticipates what the regulatory authority will require before approving the product. It is the responsibility of GRA to keep abreast of current legislation, policies, guidelines and other regulatory intelligence. The RA department plays an important role in giving advice to the program teams on how best to interpret the regulatory legislation and guidelines
• The Manager supports Global Reg Teams in the development and execution of global nonclinical / clinical regulatory strategies through a program’s lifecycle. [Open to position being Remote]
• Responsibilities may vary depending upon product regulatory lifecycle and may include the leadership of selected activities which will be delegated by the Regulatory Nonclinical/ Clinical Lead and may include the following:

Qualifications

Degree in health or life sciences, including chemistry, molecular biology, or similar. PhD preferred, Masters/Bachelors acceptable with relevant experience

Required Skills

• Decision Making and Problem Solving, including an understanding of decision-making models and methodology
• Influence, Cross-Functional Collaboration and Organizational Awareness, including demonstrating professional maturity, including understanding own strengths and receptivity to feedback
• Agility and Proactivity, including an ability to anticipate risks or issues to program or business and take the necessary steps to mitigate or address
• Leadership, such as skill in clearly communicating objectives, goals, and expectations to others
• Communication, including an ability to provide context and articulate key messages effectively and with appropriate level of detail
• Strategic Thinking and Planning, such an ability to set short-term and longer-term goals for individual objectives and task completion
• Regulatory Strategy, Frameworks and Processes: Demonstrates basic understanding of regulations, guidances and pathways including when and how to file routine submissions; asks appropriate question to clarify / validate understanding
• Health Authority Engagement: Knows basics of how relevant health authorities function, their general structure and the key personnel
• Scientific Writing for Regulatory Submissions: Demonstrates basic knowledge of content guidelines and structures (sections, etc.) for writing routine regulatory submissions (i.e., annual reports)
• Drug Development and Study Design: Understands the objectives/purpose of each drug development phase and the related objectives and regulatory requirements, including as it relates to rare disease development
• Scientific and Medical Knowledge: Understands the implications of competitive product developments on therapeutic area regulatory strategies / plans

Preferred Skills

Nonclinical / Clinical Regulatory Affairs experience preferred

Pay range:

Pay rate commensurate with experience.

Equal Opportunity Employer

No Visa sponsorship.

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