Strategist / Senior Strategist - Regulatory Affairs

ClinChoice
Bengaluru +1 more
On-site

Who this role is best for

Aimed at mid-to-senior level Regulatory Affairs professionals who support multi-country procedures and ensure compliance.

Best fit for

  • Candidates with 5-8 years of experience in pharmaceutical or related regulatory domains
    — “Minimum of 5 ~ 8 years of relevant work experience working within a Regulatory Affairs Department”
  • Professionals who can manage both direct deliverables and cross-functional collaboration
    — “Supports the team with regulatory strategies (local and regional) that are in line with the business plan”

Things to consider

  • Geographic focus on EMEA countries may require familiarity with EU-specific regulations and procedures
    — “Supports UK, Ireland, Malta, Sweden, Finland, Norway, and Denmark products across the product portfolio.”
  • The role involves maintaining and updating multiple databases, which could be data-intensive
    — “Updates to relevant local and global databases to track current product information”

How to stand out

  • Highlight experience with decentralized and mutual recognition procedures in your resume and interview responses
    — “Supports the team with regulatory activities for National and/or European procedures (Decentralized, Mutual Recognition) as appropriate.”
  • Demonstrate ability to compile and manage regulatory submissions and post-approval activities
    — “Prepares and compiles regulatory submissions, response to questions, renewals, post submission/approval activities”
  • Emphasize any prior involvement with pharmacovigilance or CFI response management
    — “Supports the team with Calls for Information (CFI) and assist in any Pharmacovigilance-related activities”
Pace · SteadyCollaboration · HighAutonomy · MediumDecision Impact · Team

Derived from job-description analysis by Serendipath's career intelligence engine.

What success looks like

  • support regulatory strategies
  • compile regulatory submissions
  • ensure regulatory compliance
  • liaise with cross-functional teams
Typical background
Bachelor's/Master's degree in Life Science/Pharma5-8 years of regulatory affairs experience

Skills & requirements

Required

Regulatory Affairs ExperienceStrategic PlanningDatabase ManagementCompliance MonitoringCommunication Skills

Preferred

Pharmaceutical ExperienceRegulatory Operations Experience

Stack & domain

Regulatory StrategiesRegulatory SubmissionsResponse To QuestionsRenewalsPost Submission/approval ActivitiesPackaging MaterialLeafletsSmpcsCompliance ReviewsAudit PreparationPharmacovigilance-related ActivitiesCalls For InformationAd Hoc RequestsRegulatory ActivitiesRegulatory ComplianceGlobal, Regional, And Local DatabasesProcessesSopsWork InstructionsJob AidsRelevant Local And Global DatabasesCurrent Product InformationRegulatory OperationsTeamworkAttention To DetailProblem-solvingCommunicationLeadershipAdaptabilityTime ManagementOrganizational SkillsCollaborationCustomer ServiceProfessionalismRegulatory AffairsPharmaceuticalCosmeticFood Supplements

About the role

Original posting from ClinChoice via Greenhouse

Responsibilities:

Supports UK, Ireland, Malta, Sweden, Finland, Norway, and Denmark products across the product portfolio.

Supports the team with regulatory strategies (local and regional) that are in line with the business plan

Supports the team with regulatory activities for National and/or European procedures (Decentralized, Mutual Recognition) as appropriate. For example, but not limited to:

Prepares and compiles regulatory submissions, response to questions, renewals, post submission/approval activities (including relevant updates to external websites such as emc, medicines.ie and In-Demand)

Supports ad hoc projects (e.g., compliance reviews, audit preparation etc.)

Signs off on packaging material, leaflets, and SmPCs (as appropriate)

Supports the compilation of the Northern Cluster team metrics for the EMEA biannual metrics report

Supports all regulatory activities in Malta

Ensures regulatory compliance within the department to include:

The maintenance of global, regional, and local databases

Adherence to processes, SOPs, work instructions, and job aids

Updates to relevant local and global databases to track current product information

Supports team with Calls for Information (CFI) and assist in any Pharmacovigilance- related activities within the Northern Cluster, which may include:

Receiving and monitoring responses to CFIs through liaison with UK and EAME colleagues

Ensuring responses are submitted in a timely manner and that they are in line with standard procedures and metrics established by the VP Regulatory Affairs in European Regulatory

Provide support and responses to ad hoc requests received from UK PV group or Global Reg Med Mailbox

Supports the team with regulatory activities for National and/or European procedures (Decentralized, Mutual Recognition) as appropriate.

Ensures regulatory compliance within the department

Experience/Qualifications:

Bachelor's/Master's degree in Life Science/Pharma

Minimum of 5 ~ 8 years of relevant work experience working within a Regulatory Affairs Department (e.g., pharmaceutical, cosmetic, food supplements, etc.), with direct accountability for deliverables or a combination of direct Regulatory Affairs experience of CMC, Quality, or Regulatory Operations.

Source: ClinChoice careers (Greenhouse)

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