Manager, Regulatory Affairs Strategy - Clinical Development
To see similar active jobs please follow this link: Remote Management jobs
Location: US – Homebased Schedule: Permanent
ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a Manager, Regulatory Affairs Strategy - Clinical Development on a permanent basis with REMOTE option in US. You will will be responsible for developing and implementing regulatory submission strategies for the European Union region, while working on projects from our varied client base, ranging from small to big pharmaceutical, biotechnology, medical device and consumer health companies.
Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career!
Main Job Tasks and Responsibilities:
The Regulatory Strategy Lead will be responsible for developing and implementing global regulatory submission strategies for global clinical trials. This role involves leading regulatory activities, developing regulatory strategies, addressing regulatory questions and concerns, participating in proposal preparation and bid defenses, and collaborating with global teams to support regulatory submission management and study start up activities.
Key Responsibilities: • Provide regulatory guidance for global clinical trial support for both drug and medical device clinical trials by leveraging personal experience and skills in regulatory intelligence gathering. • Provide Regulatory guidance to support proposal preparations. • Attend bid defense meetings to provide regulatory expertise. • With the support of the global Regulatory Affair team, lead and manage all regulatory submission activities, including planning, authoring, reviewing, and coordinating submissions for studies managed by the clinical operations team • Provide guidance on regulatory requirements and guidelines. • Represent the regulatory in strategy discussions and provide strategic expertise based on experience. • Manage interactions with regulatory authorities in support of clinical trials when requested by clients. • Provide strategic input into clinical trial submissions, including protocol and Investigator’s Brochure (IB) review and Request for Information (RFI) management. • Collaborate with cross-functional teams, to ensure regulatory alignment and support product clinical trial development. • Monitor and interpret regulatory environment changes and communicate their impact on regulatory strategies. • Ensures regulatory contributions, achieve the objectives in the strategy, achieve agreed standards, maximizing overall project delivery time and probability of success and facilitating EU submission activities.
Qualifications: • Bachelor’s degree in a scientific discipline (e.g., Life Sciences, Pharmacy, Biotechnology) or equivalent; advanced degree preferred. • Minimum of 8 years of regulatory experience in the pharmaceutical or biotechnology industry, with a focus on the clinical development phase. • Extensive knowledge of global regulatory submission and approval processes. • Proven ability to manage regulatory submissions. • Strong communication and leadership skills.
Preferred Skills: • Experience with global regulatory submissions and health authority interactions. • Experience with the EU CTIS portal. • Understanding of both medical device and pharma regulations • Ability to manage multiple projects in a fast-paced environment. • Strong problem-solving and decision-making abilities. • Previous experience as a national and/or regional regulatory liaison for a product in the clinical development phase. • Knowledge of drug development practice rules, regulations and guidelines - Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines. • Ability to communicate complex information and analyses to a variety of stakeholders in both verbal and written format.
Our Benefits:
• Excellent work-life balance • Dedicated Line Manager • Monthly meetings with line manager • Full performance and development process with end of year reviews • Team events and end of year party • Career opportunities within in ClinChoice, locally and globally • Employee satisfaction survey - your feedback is important for continuous improvement
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!
Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset, and they are the fulcrum around which all ClinChoice activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
Key words: Regulatory affairs, Clinical operations, CTIS, Pharma, Biotech, Regulatory submissions.
About the job
Manager, Regulatory Affairs Strategy - Clinical Development
To see similar active jobs please follow this link: Remote Management jobs
Location: US – Homebased Schedule: Permanent
ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a Manager, Regulatory Affairs Strategy - Clinical Development on a permanent basis with REMOTE option in US. You will will be responsible for developing and implementing regulatory submission strategies for the European Union region, while working on projects from our varied client base, ranging from small to big pharmaceutical, biotechnology, medical device and consumer health companies.
Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career!
Main Job Tasks and Responsibilities:
The Regulatory Strategy Lead will be responsible for developing and implementing global regulatory submission strategies for global clinical trials. This role involves leading regulatory activities, developing regulatory strategies, addressing regulatory questions and concerns, participating in proposal preparation and bid defenses, and collaborating with global teams to support regulatory submission management and study start up activities.
Key Responsibilities: • Provide regulatory guidance for global clinical trial support for both drug and medical device clinical trials by leveraging personal experience and skills in regulatory intelligence gathering. • Provide Regulatory guidance to support proposal preparations. • Attend bid defense meetings to provide regulatory expertise. • With the support of the global Regulatory Affair team, lead and manage all regulatory submission activities, including planning, authoring, reviewing, and coordinating submissions for studies managed by the clinical operations team • Provide guidance on regulatory requirements and guidelines. • Represent the regulatory in strategy discussions and provide strategic expertise based on experience. • Manage interactions with regulatory authorities in support of clinical trials when requested by clients. • Provide strategic input into clinical trial submissions, including protocol and Investigator’s Brochure (IB) review and Request for Information (RFI) management. • Collaborate with cross-functional teams, to ensure regulatory alignment and support product clinical trial development. • Monitor and interpret regulatory environment changes and communicate their impact on regulatory strategies. • Ensures regulatory contributions, achieve the objectives in the strategy, achieve agreed standards, maximizing overall project delivery time and probability of success and facilitating EU submission activities.
Qualifications: • Bachelor’s degree in a scientific discipline (e.g., Life Sciences, Pharmacy, Biotechnology) or equivalent; advanced degree preferred. • Minimum of 8 years of regulatory experience in the pharmaceutical or biotechnology industry, with a focus on the clinical development phase. • Extensive knowledge of global regulatory submission and approval processes. • Proven ability to manage regulatory submissions. • Strong communication and leadership skills.
Preferred Skills: • Experience with global regulatory submissions and health authority interactions. • Experience with the EU CTIS portal. • Understanding of both medical device and pharma regulations • Ability to manage multiple projects in a fast-paced environment. • Strong problem-solving and decision-making abilities. • Previous experience as a national and/or regional regulatory liaison for a product in the clinical development phase. • Knowledge of drug development practice rules, regulations and guidelines - Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines. • Ability to communicate complex information and analyses to a variety of stakeholders in both verbal and written format.
Our Benefits:
• Excellent work-life balance • Dedicated Line Manager • Monthly meetings with line manager • Full performance and development process with end of year reviews • Team events and end of year party • Career opportunities within in ClinChoice, locally and globally • Employee satisfaction survey - your feedback is important for continuous improvement
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!
Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset, and they are the fulcrum around which all ClinChoice activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
Key words: Regulatory affairs, Clinical operations, CTIS, Pharma, Biotech, Regulatory submissions.