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Senior Manager - Regulatory Affairs

10 years
Not Disclosed
10 Sept. 8, 2025
Job Description
Job Type: Full Time Education: B.Sc/ M.Sc/ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description

Primary Job Function

The position holder, with minimal managerial support, will be responsible for end-to-end regulatory affairs activities, including product registrations, compliance, cross-functional collaboration, and regulatory strategy development.


Key Responsibilities

1. Product Registrations / Submissions

  • Lead and coordinate regulatory submissions for complex filings, including new product introductions.

  • Identify and collect required data, or delegate tasks as appropriate.

  • Seek and evaluate expert advice and technical support where necessary.

  • Prepare and submit responses to deficiency letters.

2. Relationships & Cross-Functional Teamwork

  • Represent Regulatory Affairs in meetings, presenting agreed RA positions.

  • Provide expert advice and technical guidance to cross-functional colleagues.

  • Monitor actual vs. planned activities and project timelines.

  • Proactively identify, assess, and communicate risks or issues impacting project progression.

3. Affiliate Coordination

  • Build and maintain strong working relationships with Regional Product Leads and affiliate colleagues.

4. Compliance Across Product Life-Cycle

  • Assess and approve change requests, ensuring regulatory files are updated accordingly.

  • Maintain expert knowledge of applicable legislation and regulatory developments.

  • Act as subject matter expert (SME) within the business area.

  • Manage corrective action plans and ensure timely completion.

5. Regulatory Strategy

  • Lead and coordinate the development of regulatory product strategies for assigned projects.

  • Identify, communicate, and mitigate regulatory risks.

6. Process Improvement

  • Independently identify opportunities for process improvement.

  • Lead development of position papers, work aids, and best practices.

7. Health Agency Interaction

  • Prepare for and actively participate in Health Authority meetings.

  • Act as liaison or single point of contact with Notified Bodies and other relevant medical device organizations (if applicable).

8. Licensing Reviews

  • Lead and coordinate regulatory due diligence activities for assigned projects.

9. Technical Competency

  • Maintain expert knowledge of global regulatory requirements and specialist country/region/product-class regulations.

  • Ensure deep knowledge of allocated products.

  • Take proactive steps to stay updated on evolving regulatory trends.


Core Competencies

Anticipation

  • Develop contingency plans to ensure delivery under changing conditions.

  • Anticipate risks/issues and implement solutions proactively.

  • Gather customer insights to fulfill needs effectively.

  • Adjust approach based on audience or situation to achieve results.

Adaptability

  • Prioritize and plan long-term tasks and projects effectively.

  • Identify synergies across the organization with a “big picture” mindset.

  • Reassess commitments, reprioritize activities, or negotiate timelines as needed.

  • React quickly to resolve emerging problems.

Initiative

  • Demonstrate clear understanding of organizational roles and functions.

  • Anticipate, mitigate, and prevent issues proactively.

  • Seek feedback and adapt behavior to enhance performance.

  • Maintain strong customer focus.

Innovation

  • Apply intrapreneurial thinking to solve challenges in unique ways.

  • Encourage experimentation and learning from failure.

  • Challenge conventional approaches and generate new ideas.

  • Integrate diverse perspectives to create innovative solutions.

Integrity

  • Deliver high-quality work within agreed deadlines.

  • Communicate honestly and provide impartial information.

  • Ensure consistency between words and actions.

  • Respond constructively to mistakes and failures.

Teamwork

  • Actively contribute to achieving both individual and shared team goals.


Leadership Competencies

Set Vision and Strategy

  • Influence and align cross-functional stakeholders around strategic regulatory priorities.

  • Develop robust regulatory strategies for complex global projects.

Build Organization and Inspire People

  • Mentor and train junior team members.

  • Share expertise and provide leadership in day-to-day activities.

  • Contribute to functional and business improvement.

Drive Results

  • Demonstrate persistence and accountability to deliver commitments.

  • Balance short-term and long-term priorities effectively.

  • Act promptly and appropriately in decision-making.

  • Overcome organizational or cultural barriers to success.

Make Difficult Decisions

  • Identify and escalate crisis situations appropriately.

Encourage Open Environment & Knowledge Sharing

  • Provide frequent, constructive feedback.

  • Share information transparently with peers.

  • Promote an open culture of challenge and collaboration.


Supervisory / Management Responsibilities

  • Direct Reports: None (Individual Contributor)

  • Indirect Reports: None (Individual Contributor)


Qualifications

Education

  • Bachelor’s degree in Pharmacy, Biology, Chemistry, Pharmacology, or a related field.

Experience

  • Minimum 10+ years of experience in Regulatory Affairs, R&D, Manufacturing, or a related area.

  • Exceptions may be made for candidates with fewer years of experience if supported by higher academic qualifications or specialized expertise.