Pharma Jobs: ClinChoice is Hiring a Senior Associate – Apply Now For Regulatory Affairs Jobs
Are you currently looking for Pharma Jobs in Bengaluru? ClinChoice is seeking a skilled Senior Associate – Regulatory Affairs (Northern Cluster) to join its Bengaluru team. The Regulatory Affairs Job role involves supporting regulatory operations across multiple countries, including the UK, Ireland, Malta, Sweden, Finland, Norway, and Denmark. This is an excellent opportunity for experienced professionals in Regulatory Affairs to contribute to impactful projects, ensure compliance, and support international submissions and post-approval activities. Apply now for this pharma job and kickstart your career.
Job Details:
- Job Title: Senior Associate – RA (Northern Cluster)
- Location: Bengaluru, India
About the Company:
ClinChoice is a global clinical research organization (CRO) dedicated to advancing healthcare through high-quality, end-to-end clinical development and post-marketing services. With over two decades of experience, ClinChoice partners with leading pharmaceutical, biotechnology, and medical device companies to bring safe and effective treatments to patients worldwide.
Operating across North America, Europe, and Asia, ClinChoice offers comprehensive solutions in clinical operations, pharmacovigilance, regulatory affairs, biometrics, medical writing, and real-world evidence. The company is known for its commitment to quality, innovation, and compliance, ensuring that every project meets global regulatory standards.
Driven by its mission to deliver Better Solutions for Better Health, ClinChoice fosters a collaborative and growth-oriented work culture, empowering professionals to make meaningful contributions to global healthcare outcomes.
Qualifications Required for Regulatory Affairs Job Role:
- Bachelor’s/Master’s degree in Life Science/Pharma.
- Minimum of 3 ~ 5 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.
Key Responsibilities for Regulatory Affairs Job Role:
- Supports the Northern Cluster team (as appropriate) for 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 (e.g., Documentum, Aris, Connect etc.) to track current product information.
- Supports the Northern Cluster 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.
