Find Associate director, regulatory affairs pricing & underwriting Jobs in Finglas, D

Associate Director, CMC Regulatory Affairs (Hematology/Oncology)
Regeneron —Dublin, County Dublin
- €101,500–€165,200 a year
- Bachelor's degree
- No degree
- In-person
- Annual leave
Associate Director, Drug Product Development
Jazz Pharmaceuticals —Dublin, County Dublin
- €157,600–€236,400 a year
- Engineering
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Associate Director Inspection Management (GCP)
Regeneron —Dublin, County Dublin
- €101,500–€165,200 a year
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Associate Director – Advanced Process Analytics, Data Literacy & Modelling (Dunboyne)
MSD —Dunboyne, County Meath
- Full-time
- Hybrid work
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1d
Clinical Quality Assurance - Program Lead (Associate Director)
Novartis —Dublin, County Dublin
- €72,800–€135,200 a year
- Full-time
- Doctoral degree
- Master's degree
- Bachelor's degree
Associate Director - Privacy Technologies
Grant Thornton —Dublin, County Dublin
- Full-time
- Azure
- Master's degree
- AI
PGIM | Director, Designated Person For Fund Risk (PCF 39C)
PGIM —Dublin, County Dublin
- Full-time
- Python
- Annual leave
Associate Director, Commercial Launch & Project Management
Regeneron —Dublin, County Dublin
- €101,500–€165,200 a year
- Microsoft Office
- Master's degree
- Project management
- Annual leave
Associate Director, Pharmacovigilance Operations (Contract)
PTC Therapeutics International Limited —DUBLIN 2, County Dublin
- Full-time
- Management
- Microsoft Office
- Bachelor's degree
Quick apply
4d
MS&T Raw Materials and Validation Lead – Associate Director - Dunboyne
MSD —Dunboyne, County Meath
- Full-time
- Hybrid work
- Engineering
- Continuous improvement
- Cleaning
1d
Associate Director, Client Onboarding Solutions (Fund Accounting) - Yardi Experience
MUFG Investor Services —Dublin, County Dublin
- Full-time
- Hybrid work
- Microsoft Excel
- AI
- Leadership
Quick apply
Data & AI Consultant – Associate Director - ROI / Belfast
Grant Thornton —Dublin, County Dublin
- Full-time
- Azure
- SQL
- Business development
11d
Workplace Experience Associate
DocuSign —Dublin, County Dublin
- Remote
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Internal Audit - Senior Associate
PwC —Dublin, County Dublin
- Full-time
- Bachelor's degree
- Accounting
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Company Secretary/Board Governance - Associate
BlackRock Investments —Dublin, County Dublin
- €75,000–€105,000 a year
- Organisational skills
- AI
- Communication skills
- Work from home
2d
Associate Director, Web Analytics
Novartis —Dublin, County Dublin
- €83,800.50–€155,629.50 a year
- Full-time
- Business
- Analytics
Associate Director - FP&A
Ergomed —Dublin, County Dublin
- Full-time
- Hybrid work
- English
- Analysis skills
- Continuous improvement
Quick apply
PGIM | Director, Designated Person For Fund Risk
Prudential —Dublin, County Dublin
- Full-time
- Python
- Annual leave
Senior Surveyor (Associate/Divisional Director)Professional Services
BNP Paribas —Dublin, County Dublin
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Business Development Associate Director
KPMG —Dublin, County Dublin
- Weekend availability
- Microsoft Powerpoint
- Microsoft Excel
- Microsoft Office
- Relocation assistance
- Annual leave

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Associate Director, CMC Regulatory Affairs (Hematology/Oncology)

Regeneron -
Dublin, County Dublin

Apply Now

Job details

€101,500–€165,200 a year

Benefits

Annual leave

Qualifications

Bachelor's degree

Full job description

Build our future together:

As an Associate Director you will lead the development and execution of global CMC regulatory strategies for the hematology and oncology portfolios. You will guide regulatory activities across development stages, mentor CMC Regulatory Affairs (RA) staff, supporting cross-functional and external partners, and serving as a key liaison in regulatory authority interactions.

Where and when:

This is a Dublin, Ireland based position and would you to be on-site 3 days per week and 2 days from home. A fully remote role is not possible for this position. If eligible, we can offer relocation benefits.

Discover your role:

Lead product development activities from a CMC regulatory standpoint with input from senior management.

Represent CMC RA at program meetings and independently provide regulatory interpretation, position, and covering clinical development, initial market applications, and approval/post-approval activities.

Identify program issues and develop appropriate regulatory strategies to mitigate risks to filings, independently find alternative solutions/work-arounds, and obtain consensus.

Critically review and provide meaningful and strategic input on regulatory filing documents (e.g., INDs, IMPDs, meeting packages, scientific advice, BLAs, MAAs, BPDRs, annual reports, DSUR, amendments, supplements) to facilitate and expedite the development, licensure, and marketing of drugs and/or biologics.

Lead and facilitate interactions with global regulatory authorities (e.g., meetings, IR responses, inspections).

Perform final review and approval of the compliance activities of the portfolios to confirm regulatory impact and associated submission requirements for clinical and commercial regulatory filings in accordance with country-specific regulatory guidance documents;

Mentor colleagues in difficult compliance assessment discussions with SMEs or Senior Management; find opportunities for improvement of processes for compliance tasks.

Develop and create working instructions, SOPs, and/or templates to facilitate consistent and efficient practice across the CMC RA groups.

Identify gaps in the IOPS and global RA processes, bring up to higher management, and help to improve business efficiency.

Support establishing, managing, and maintaining a knowledge base of current and emerging regulatory requirements and guidelines in the CMC field.

• Find opportunities to initiate operational changes and policy modifications.• Manage and coach team member(s).

This role requires:

To be considered a bachelor’s degree with a minimum of 10 years of pharmaceutical/biotech industry experience, including 5+ years of relevant CMC experience. An advanced degree is preferred.
Proven track record supporting biological products through development and approval is a distinct advantage.
It is required to have a good understanding of current CMC worldwide regulations and guidelines.
Experience in interacting with the US FDA and other regulatory authorities. Experience with device regulatory requirements and development processes for combination products is a plus.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

€101,500.00 - €165,200.00

Apply Now

Refine Your Search

associate director, regulatory affairs pricing & underwriting jobs in finglas, d

Associate Director, CMC Regulatory Affairs (Hematology/Oncology)

Associate Director, Drug Product Development

Associate Director Inspection Management (GCP)

Associate Director – Advanced Process Analytics, Data Literacy & Modelling (Dunboyne)

Clinical Quality Assurance - Program Lead (Associate Director)

Associate Director - Privacy Technologies

PGIM | Director, Designated Person For Fund Risk (PCF 39C)

Associate Director, Commercial Launch & Project Management

Associate Director, Pharmacovigilance Operations (Contract)

MS&T Raw Materials and Validation Lead – Associate Director - Dunboyne

Associate Director, Client Onboarding Solutions (Fund Accounting) - Yardi Experience

Data & AI Consultant – Associate Director - ROI / Belfast

Workplace Experience Associate

Internal Audit - Senior Associate

Company Secretary/Board Governance - Associate

Associate Director, Web Analytics

Associate Director - FP&A

PGIM | Director, Designated Person For Fund Risk

Senior Surveyor (Associate/Divisional Director)Professional Services

Business Development Associate Director

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