
Director, Regulatory
1 week ago
Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.
The Director Regulatory Affairs will provide leadership of teams responsible for regulatory submissions worldwide. The Director Regulatory Affairs will provide regulatory strategy and support for all regulatory and ethics submission in relation to Clinical Trials and drug development including Health Authority interaction, attending meetings, and provision of strategic regulatory support to other departments, project teams, and committees. The Director Regulatory Affairs will support the development of the Regulatory department and enhance corporate Regulatory functions and facilitate business development and proposals in this area.
Essential functions of the job include but are not limited to:
- Provide strategic, technical, and regulatory guidance to clients and team members in the area of clinical development of human medicinal products and drug development life cycle
- Establish operational objectives and assignments for assigned team members
- Track and report regulatory function metrics and key performance indicators
- Oversee, review and provide strategic input on applications to Regulatory Authorities including, but not limited to, CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and expedited pathways
- As needed, review documents intended for submission to the Regulatory Authorities and/or Ethics Committees to ensure compliance with regulatory standards
- Select, train, develop, coach and manage the performance of Regulatory Managers, ensuring the sharing of best practices across the team
- Oversee resource allocation and utilization of Regulatory Managers
- As needed, represent Global Regulatory Affairs at project team meetings with both external and internal customers and manage/oversee regulatory workflow between departments
- Provide oversight to filing and study teams regarding regulations/guidelines and company SOPs to ensure successful and high-quality regulatory applications
- Ensure budgets and plans meet corporate requirements
- Provide ICH/GCP/Regulation guidance, advice and training to internal and external clients
- Participate in developing, implementing, and maintaining the corporate quality initiatives across business units within Clinical Solutions/Precision for Medicine
- Implement regulatory tools to support the department
- Assist in developing, modifying and executing company policies that affect Regulatory Affairs and may impact other departments
- Support QA audits and/or assign applicable team members to participate in audits
- Establishes and maintains a high level of technical knowledge in the area of product development and international regulatory affairs. Interprets emerging regulatory requirements and collaborates in impact assessment and implementation
- Supports Business Development in generation of customer focused, well-presented regulatory proposal content and budgets, partnering with other functional areas as required to define bid content, strategy, scope of work
Qualifications:
- Post Graduate Degree, Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline
- 10+ years or more relevant regulatory affairs experience in CRO, Pharma, Biotech or related industry
- Extensive and broad knowledge and experience of all aspects of drug development process, including subject matter expertise in regulations and guidelines (including but not limited to: NA, EMA, APAC, national authorities and IHC/GCP/GMP)
- Proven track record of supporting client development activities leading regulatory pharmaceutical product development and managing complex regulatory clinical programs
Preferred:
- Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC (or equivalent) certification/Masters in Regulatory Sciences
- Experience in functional management including experience in delegating while fostering cohesive team dynamics
- Possesses understanding of financial management
Other Required:
- Expert knowledge of all aspects of the drug development process inclusive of regulatory milestones
- Exhibits advanced specialized knowledge of regulatory activities in at least one major region (EU/US/APAC) including but not limited to submissions to Regulatory Authorities, including INDs/CTAs and amendments, Scientific Advice Procedures, and post-approval submissions
- Informed knowledge of all aspects of the drug development process inclusive of regulatory milestones
- Specialized knowledge of regulatory activities including but not limited to submissions to Regulatory Authorities, including INDs/CTAs and amendments, ODDs and PIPs.
- Ability to understand clinical and pre-clinical study results, to help in its interpretation for regulatory positions and strategy
- Expert knowledge of clinical trials methodology, including a knowledge of protocols and indications being studied
- In-depth knowledge and expertise with relevant global regulations and guidelines supporting clinical pharmaceutical development ((includes but not limited to FDA, EMA, other international regulations and ICH-GCP guidelines) and the ability to communicate such to internal and external clientsAble to understand and communicate regulatory requirements for pharmaceutical development submissions during the life cycle of a product.
- Ability to guide, train, and supervise personnel; oversee the work of direct reports to ensure on-time, on-target and within-budget results
- Availability for domestic and international travel including overnight stays
- Excellent presentation, verbal and written communicator with strong interpersonal skills.
- Ability to manage multiple and varied tasks in a fast-paced environment while excellent record keeping skills.
- Ability to work on significant complex issues where analysis of situations or data requires an evaluation of intangibles
- Foster a culture of mutual respect and collaboration
- Ability to change the thinking of or gain acceptance of others in sensitive situations
- Ability to prepare and conduct presentations of a technical nature to senior management within functional area
- Ability to create an environment where employees have a sense of ownership that will lead to increases in productivity and efficiency
- High level of integrity and must inspire and demand the highest standards from a professional and ethical perspective
- Makes decisions based on resource availability and functional objectives
- Ability to exercise independent judgement and manage ambiguity
- Ability to prioritize and delegate tasks
- Ability to coordinate, manage and supervise multiple projects
- Results oriented, accountable, motivated and flexible
- Proven ability to communicate with senior management, external thought-leaders and operational staff
We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.
About Precision for Medicine:
Precision for Medicine is a precision medicine Clinical Research Organization. Precision's uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas.
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to ourCA Privacy Notice .
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com .
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
Create a Job Alert
Interested in building your career at Precision for Medicine? Get future opportunities sent straight to your email.
Apply for this jobindicates a required field
First Name *
Last Name *
Email *
Phone *
Resume/CV *
Enter manually
Accepted file types: pdf, doc, docx, txt, rtf
Enter manually
Accepted file types: pdf, doc, docx, txt, rtf
Education
School Select...
Degree Select...
Select...
Start date year
LinkedIn Profile
What is your desired salary? *
Are you authorized to work lawfully in the country/location for which you are applying? * Select...
Will you now or in the future require Precision Medicine Group to commence (sponsor) an immigration case in order to employ you (for example, work visa application or work visa transfer, or other-employment based immigration case)? This is sometimes called "sponsorship" for an employment-based visa status. * Select...
Have you ever worked for Precision Medicine Group or one of its affiliated companies? * Select...
If yes, when and which company?
Have you ever interviewed with Precision Medicine Group or an affiliated company? * Select...
If yes, when and which company?
Are you currently subject to a Non-Compete or Non-Solicit with your current employer? * Select...
I certify that the information on this application, my resume and any supporting documentation I provide is complete and accurate to the best of my knowledge. If this application leads to employment, I understand that false or misleading information in my application, resume or interview may result in my release or termination of employment. I authorize the Company or its agents to confirm all statements contained in this application and/or curriculum vitae as it relates to the position I am seeking and to the extent permitted by the laws of the country where the job is located ("Applicable Laws"). I agree to complete any required authorization forms for the background investigation. I authorize and consent to, without reservation, any party or agency contracted by this employer to furnish the above-mentioned information. I hereby release, discharge, and hold harmless, to the extent permitted by Applicable Laws, any party delivering information to the Company or its duly authorized representative pursuant to this authorization from any liability, claims, charges or causes of action which I may have as a result of the delivery or disclosure of the above requested information and all other persons, corporations, or organizations furnishing such information. If hired, I understand that I will be required to provide genuine documentation establishing my identity and eligibility to be legally employed in the country where the job is located. I also understand that the Company employs only individuals who are legally eligible to work in the country where the job is located. * Select...
#J-18808-Ljbffr-
Regulatory Affairs Director
4 days ago
Singapore PharmEng Technology Full time**Regulatory Affairs Director** Join a leading global organization as a **Regulatory Affairs Director**, shaping regulatory strategies across multiple regions. This high-impact role ensures compliance, drives regulatory approvals, and collaborates with senior leadership and health authorities worldwide. **Key Responsibilities**: Develop and implement...
-
Director of Regulatory Affairs and Quality
1 week ago
Singapore Barrington James Full timeDirector of Regulatory Affairs and QualityDirector of Regulatory Affairs and QualityDirect message the job poster from Barrington JamesHead of Regulatory Affairs & Quality, Asia.I am engaged by a global medical devices company to appoint a Head of Regulatory Affairs and Quality for Asia.This senior leadership position will guide regulatory direction and...
-
Director / Associate Director - Regulatory Affairs
23 hours ago
Singapore beBeeCompliance Full timeJob Title: Compliance Director / Associate Director">We are seeking an experienced Compliance Director/Associate Director to join our team in Singapore.The successful candidate will be responsible for overseeing the Singapore compliance function and advising on all Singapore-related compliance and regulatory matters. This includes acting as a liaison with...
-
Director, Regulatory Compliance
5 days ago
Singapore Amethyst Partners Full timeL- Posted by - Loretta Chan- Director Our client is an international service provider that they provide a wide range of services such as regulatory compliance advisory services to their clients. Their clients are mainly in the financial services industry including asset management such as hedge funds, private equity funds, venture capital, payment solutions...
-
Director, Regulatory
2 days ago
Singapore Precision for Medicine Full timePrecision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific...
-
Regulatory Affairs Associate Director
2 weeks ago
Singapore Ethos BeathChapman Full time**Job Details**: **Location** Singapore **Salary** Competitive Salary **Job Type** Permanent **Ref** BH-178593 **Contact** Piers Atkinson- **Posted** about 1 hour ago - A new entrant to Asia, this Biopharma is looking for a Regulatory Affairs Associate Director. - You will be in charge of all things regulatory in APAC where currently they don’t...
-
Singapore Eli Lilly and Company Full timeAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
-
Regulatory Affairs Director
2 weeks ago
Singapore Novo Nordisk Full timeRegulatory Affairs Director **Category**:Reg Affairs & Safety Pharmacovigilance **Location**:Singapore, Singapore, SG **About the department** - You will join our Regulatory Affairs team in Region APAC, based in Singapore. Our team is responsible for ensuring regulatory compliance for new products and product amendments, thereby keeping our license to...
-
Singapore Eli Lilly and Company Full timeAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
-
Director, Regulatory Affairs
3 days ago
Singapore Satcom Direct Full timeGogo Business Aviation is looking for a **Regulatory Affairs Director** to obtain regulatory approvals globally, with a primary focus on the Asia Pacific region, for operation of Gogo’s global broadband inflight connectivity system to enable Wi-Fi and GEO and LEO satellite connectivity onboard business airlines. You will develop and manage partnerships...