Manager, Regulatory Affairs

Worldwide; India; Vor Ort; INR 1.500.000 - 2.500.000; Vollzeit

Zusammenfassung

Worldwide Clinical Trials is seeking a Manager, Regulatory Affairs to provide representation and input across the drug development cycle. You will lead regulatory projects, coordinate submissions, and liaise with the Regulatory Affairs Director to plan and submit timely regulatory dossiers globally.

The role requires strong knowledge of ICH GCP, drug development, and experience in a CRO/pharmaceutical setting.

Qualifikationen

• Bachelor's Degree in Chemistry or Life Sciences, Nursing or equivalent experience.
• Previous experience within the pharmaceutical/CRO industry.

Aufgaben

• Provide expert regulatory advice and contribute to regulatory project work.
• Ensure accurate compilation, management and tracking of submissions.
• Coordinate & manage regulatory & ethics committee submissions and maintain approvals throughout EMEA, Asia Pacific and Latin America regions.
• Stay abreast of changing regulatory legislative requirements and ensure maintenance of the regulatory intelligence database.
• Review and make recommendations on all relevant documentation to ensure compliance with ICH GCP & country specific requirements.

Kenntnisse

Regulatory affairs

Leadership

Project management

Communication

MS Office

ICH GCP

Drug development

Ausbildung

Bachelor's Degree in Chemistry or Life Sciences

Jobbeschreibung

Who we are We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs - in the best possible way. Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

Why Worldwide We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day.

Summary

The Manager, Regulatory Affairs provides project representation and input to projects awarded to WCT for all stages of the drug development cycle and ensures the smooth running of the Regulatory Affairs Department.

Responsibilities

• Provide expert regulatory advice and contribute to regulatory project work
• Ensure accurate compilation, management and tracking of submissions
• Participate in business development activities preparing regulatory sections of proposals and feasibility reports, regulatory costing and budgets and attend bid defense meetings to meet business needs
• Develop department work practices and other company initiatives
• Liaise with the Regulatory Affairs Director to plan, organise, compile progress and submit regulatory submissions on a timely basis
• Coordinate & manage regulatory & ethics committee submissions and maintain approvals throughout EMEA, Asia Pacific and Latin America regions
• Stay abreast of changing regulatory legislative requirements and ensure maintenance of the regulatory intelligence database
• Contribute towards the preparation of technical documentation such as IMPDs and IBs which may involve chemical, pharmaceutical, toxicological, pharmacological and clinical aspects of specified regulatory submissions
• Review and make recommendations on all relevant documentation e.g. labels, patient information sheets, diary cards ...to ensure compliance with ICH GCP & country specific requirements
• Effectively communicate status of submissions with the Sponsor, Project Manager, CRAs, Medical & Scientific Affairs staff
• Comply with SOPs, ICH GCP and national regulations as applicable
• Foster professional working relationships with internal and external contacts at the local and international levels to ensure expeditious submission/approval of regulatory dossiers
• Provide training, coaching and mentoring to junior members of staff, may be required to line manage junior members of staff
• Deputised for the Regulatory Affairs Director as required
• Perform other duties as assigned

Other Skills and Abilities

• Clearly, proven leadership and organizational management skills are essential attributes
• Strong planning, strategizing, managing, monitoring, scheduling, and critiquing skills
• Excellent written and verbal communication skills to clearly and concisely present information
• Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
• Excellent ability to handle multiple tasks in a fast-paced and constantly changing environment
• Ability to exercise sound judgment and make decisions independently
• Excellent self-motivation skills
• Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint
• Expert knowledge of ICH GCP and the EU Clinical Trials Directive/National regulations (CTAs, Amendments, Urgent Safety Measures, End of Trial Notifications)
• Expert knowledge of drug development

Requirements

• Bachelor's Degree in Chemistry or Life Sciences, Nursing or equivalent experience
• Previous experience within the pharmaceutical/CRO industry

Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.

We love knowing that someone is going to have a better life because of the work we do.

Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity.

We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.

We’re a team of clinicians, scientists, and researchers who want to make healthcare better. We were founded on an unwavering commitment to authentic, personalized attention. And today, as CROs consolidate and the industry changes rapidly, that personalized attention is more important than ever. We all came to this industry for different reasons, from different walks of life. If you ask any one of us why we’re here, you’ll get a different answer. And that’s what makes us special.