BENGALURU · FULLTIME
Strategist / Senior Strategist - Regulatory Affairs
ClinChoice
Bengaluru · onsite · Posted 2d ago
Sourced from
Undisclosed8–13 yrsfulltimeBengaluru
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Section · 01
About this role
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
- Bachelors/Masters 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.
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
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Section · 02
Skills
emcAuditingpharmacovigilanceproduct portfolioRegulatory AffairsMonitoringPackagingBusiness PlanningRegulatory CompliancePharma
Section · Company
About ClinChoice
ClinChoice
Clinical Research
201
employees
1995
31 years old
Bangalore / Bengaluru, Karnataka
India
₹6.4L PA avg
Avg at ClinChoice
About
ClinChoice operates as a clinical research organization, delivering high-quality and flexible clinical trial solutions across the pharmaceutical and medical device industries.
Industries
Clinical Research
Employee ratings
10 reviews
4.0/ 5
Culture
4.0
Career growth
3.2
Work-life
4.6
Employees rate it well for
Work-Life Balance43Company Culture41
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