Regulatory Project Manager (Global Regulatory Affairs)
Company Overview
Join a global organization driven by innovation in Healthcare, Life Science, and Electronics. The company is committed to improving lives through science and technology, fostering collaboration across diverse teams worldwide.
The organization values curiosity, inclusion, and continuous innovation, working across global markets to support patients and customers through advanced scientific solutions.
Role Overview
The Regulatory Project Manager is responsible for global regulatory planning, coordination, and tracking of deliverables for moderately to highly complex regulatory submissions to health authorities worldwide.
The role ensures effective execution of regulatory strategies, lifecycle management activities, and cross-functional coordination within a matrix organization.
Key focus areas include:
Regulatory submission planning and execution
Cross-functional coordination
Risk and crisis management
Budget and resource planning
Operational oversight of regulatory projects
Key Responsibilities
1. Regulatory Project Planning & Execution
Develop project plans for regulatory submissions including:
CTA / IND
MAA / NDA / BLA
Health Authority meetings and Scientific Advice
Ensure simplified yet effective planning aligned with submission complexity
Orchestrate execution of submissions to health authorities
2. Cross-Functional Coordination
Collaborate closely with:
Global Regulatory Leads (GRL)
Regulatory Affairs Managers
Submission Managers
GRA Operations teams
Enable smooth handover of submission plans to operational teams
Ensure clear communication across matrix teams
3. Submission Task Force Leadership
Lead and coordinate Submission Task Force (STF)
Ensure alignment of deliverables and dependencies
Manage risks, issues, and interdependencies across teams
Drive hyper-care support for critical submissions
4. Risk & Crisis Management
Establish and maintain risk registers (GRST and STF)
Manage GRA-owned risks in iMAP system
Provide crisis intervention to protect timelines and quality
5. Regulatory Operations & Lifecycle Management
Manage operational aspects of product lifecycle activities
Support post-approval changes and regulatory maintenance activities
Ensure compliance with global regulatory requirements (EU and international)
6. Budget & Financial Management
Consolidate and track GRA & RDQ budget demands
Coordinate with project controllers and global project management teams
Ensure purchase orders (POs) are established for project-related costs
Support quarterly cost planning in iMAP system
Compare planned vs actual spending
7. Asset Transfer & Deal Support
Act as key contact after licensing deals (in-licensing / out-licensing)
Support operational asset transfer activities
Coordinate initiation of internal regulatory activities post-deal closure
8. Tools, Systems & Process Improvement
Improve and maintain regulatory project management tools and templates
Ensure compliance with Health Authority requirements
Work with systems such as:
RIM (Regulatory Information Management)
EDMS (Electronic Document Management Systems)
iMAP system
Required Knowledge & Skills
Regulatory Expertise
Strong understanding of:
Global regulatory procedures and submissions
Post-approval regulatory changes
Regulatory dossier types
Knowledge of supporting documents such as:
CPPs (Certificates of Pharmaceutical Product)
GMP Certificates
Manufacturing Licenses
Authorization documents (Ato, AF, CL, PoA, etc.)
Compliance & Standards
Strong knowledge of EU and international regulatory requirements
Understanding of lifecycle management for approved pharmaceutical products
Technical & System Skills
Experience with:
Regulatory Information Management (RIM) systems
Electronic Document Management Systems (EDMS)
Contributor-level experience in regulatory digital platforms
Soft Skills
Excellent written and verbal communication (English)
Strong teamwork and collaboration skills
Ability to influence across matrix organizations
Strong ownership and accountability mindset
Strong customer orientation
Ability to balance detail orientation with big-picture thinking
High results orientation
Experience Requirements
8–14 years of total professional experience in:
Pharmaceutical industry
Regulatory authorities
Academia or R&D (relevant experience)
6–8 years of experience specifically in:
Regulatory Affairs
Regulatory Project Management
Education Requirements
Minimum: Master’s degree (MSc or equivalent) in:
Life Sciences
Medical Sciences
Pharmacy (PharmD)
Related scientific discipline
Preferred:
PhD in a scientific discipline
Advanced training in portfolio or project management
Financial Responsibilities
Support quarterly cost planning using iMAP system
Consolidate direct cost demand and monitor actual spending
Support GRA-related budget tracking within PST framework
What the Company Offers
Inclusive and diverse work environment
Global career development opportunities
Strong focus on innovation and collaboration
Continuous learning and personal growth opportunities
Supportive culture promoting inclusion and belonging
Equal Employment Opportunity
The company is an equal opportunity employer and does not discriminate based on:
Race, color, religion
Gender, sexual orientation, or gender identity
Age, disability, or veteran status
National origin or any other protected characteristic
All employment decisions follow applicable laws and internal policies.
Fraud Alert
Be cautious of fraudulent job offers. Always verify job opportunities through official company channels before sharing personal information.
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Remote, India | Siliguri |Illinois :
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Dickinson |Minnesota :
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Frank Scottile Blvd |Missouri :
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Mexico |northeastern :
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Tuscaloosa |D.C :
Washington |Delaware :
Wilmington |North Rhine Westphalia :
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Bavaria |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Brandenburg :
Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
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Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
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Saarbrucken |Switzerland :
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Belgrade | Serbia |Hungary :
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Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
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China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Haarlem |South Holland :
Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
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Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
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Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
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Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
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Madrid |Cebu Province :
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Croatia |Zagreb :
Zagreb |Estonia :
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Ho Chi Minh City |Italy :
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Japan | Saitama |Tokyo :
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