Regulatory Affairs Manager

3 weeks ago

Chicago, United States Mindlance Full time

Job Title: Regulatory Affairs Manager III

Location: REMOTE

Duration: 06 months with possible extension


SUMMARY

The Regulatory Affairs Specialist will be the regulatory representative for assigned due diligences, under the direction of the Global Regulatory Strategy Lead (GRSL).

An external company and assets or individual assets alone can be the subject of due diligence. As a member of a diligence team, you will be responsible for contributing to the diligence on behalf of regulatory affairs and will be empowered to seek optimal strategies and challenge assumptions to meet in-scope objectives and milestones. You will be responsible for the assessment of information that will lead to a regulatory recommendation.

In addition, you may be an assigned regulatory representative for a product/s within a therapeutic area. In this case, you will identify and assess regulatory risks associated with product development and define strategies to mitigate risks in alignment with the global business strategy. You may represent the company to the FDA or EMA as well as to corporate partners.

A. Essential Functions:

• Being part of an internal diligence team, with personal responsibility to provide strategic and technical regulatory guidance to the diligence team for external diligences. This includes working with external companies and the internal diligence team on discrete products for multiple indications, from pre-clinical development through life cycle management.

• Responsible for developing and maintaining an in-depth regulatory knowledge of the disease areas of each due diligence that you are involved with, including competitor intelligence and current and emerging global guidelines and regulations.

• Assess public and company confidential information and digest and extract relevant key information efficiently to inform on and make recommendations, for example, orphan drug applications, Health Authority advice (EMA and FDA), paediatric plans, clinical trial designs and HA feedback. The assessment will include proposing strengths, gaps and potential mitigations of the available data and clinical development plans plus major HA interaction and filing timelines. The ability to understand and interpret pertinent information will be based upon your deep and broad global regulatory experience.

• Accountable, with the GRSL, for providing a regulatory recommendation to proceed with diligence, or not.

• In additional to due diligence responsibility, may also have responsibility for identifying and progressing global regulatory strategies for a product within the assigned *** portfolio. This would involve working with a project team, integrating regional requirements (US, EU) and liaising with regional *** regulatory leads to develop an integrated global proposal (JP, China, etc.) on different stages of product development from pre-clinical development through to life cycle management.

• Work closely with regulatory colleagues across therapy areas to ensure consistent approaches to Health Authorities

• Identify and assess regulatory risks associated with product development. Define strategies to mitigate risks.

• Provide regulatory guidance to company personnel throughout the research and development process.

• Responsibility for liaising with *** regulatory leads to ensure submissions are made, which may include US or EU applications and requests for advice and/or be directly responsible for the preparation of submissions.

• Advise on global CTA submission strategy.

• Monitor and analyse appropriate regulatory agency activities in areas of interest to the company and assess impact on programs.

Qualifications

• Minimum Scientific Degree (BSc, or MD, PhD, PharmD, MSc) or equivalent experience in drug, device, development and commercialization.

• Demonstrated experience in drug development

• Minimum of 12 years pharmaceutical/biotechnology industry experience with technical management experience. Minimum of 10 years in Regulatory Affairs.

• In depth and relevant Global regulatory experience (in US, Europe and other regions)

• Experience in regulatory due diligence activities

• Demonstrated strategic thinking and ability to integrate strategies into actionable plans

• Experience in interpretation of regulations, guidelines, policy statements, etc.

• Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.

• Direct experience in interfacing with regulatory authorities.

• Well organized, detail oriented, effective written and oral communication skills.

• Ability to represent the department in project teams and external company meetings.

• Strong sensitivity for a multicultural/multinational environment. Experience leading multi-disciplinary teams.

• Strong interpersonal skills and the ability to deal effectively with a variety of senior personnel including medical, scientific, and manufacturing staff.

• Demonstrate strong organizational skills, including the ability to prioritize personal workload.


EEO:

“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”

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