Shalina Healthcare
Website:
shalina.com
Company:
https://www.linkedin.com/company/shalina-healthcare
Industries: Pharmaceutical Manufacturing
Job details:
About This Job
Shalina Healthcare
Location: Mumbai, Maharashtra, India
Work Mode: On-site
Industry: Pharmaceutical Manufacturing
Job Description
Role Description – Associate Manager – Medical Affairs – COE, Mumbai
About Shalina Healthcare
Shalina Healthcare is one of the largest pharmaceutical companies in sub-Saharan Africa. For the last 40 years we have made it our mission to provide quality medicines to those who need it the most. We manufacture and distribute branded prescription and over-the-counter pharmaceutical and consumer products, across a broad range of therapeutic groups, including anti-malarial, antibiotics, anti-inflammatory and nutrition. We have a track record few can match, and our brands are among the most trusted in Africa.
We are proud of our history and have big ambitions for the future. Our vision for 2030 is to be the health champion of Sub-Saharan Africa. To achieve this, we are looking for the right people to join us and create a lasting impact not just within our company but on the communities we serve.
Everyone in our company has a crucial role to play, and we are looking for people who identify with our Core Values and are as passionate about our Mission as we are.
Role: Associate Manager – Medical Affairs
Base location: Mumbai
What You Become a Part Of
The successful candidate in this role will get an opportunity To manage and support clinical trial operations, clinical data management (CDM), and regulatory activities for international markets, with a key focus on Africa. The role will ensure compliance with applicable regulatory requirements, oversee clinical study execution, manage clinical data integrity, and coordinate with cross-functional teams to facilitate product registrations and lifecycle management.
What To Expect
Plan, coordinate, and monitor clinical studies in compliance with GCP, ICH guidelines, and applicable regulatory requirements.Liaise with CROs, investigators, ethics committees, and internal stakeholders for smooth execution of clinical trials, including vendor management.Manage study timelines, budgets, documentation, and study-related deliverables.Review and maintain Trial Master Files (TMF) and ensure inspection readiness.Monitor study progress and provide periodic updates to management.Oversee end-to-end clinical data management activities including CRF/ Protocol Synopsis/ Protocol Design, data validation, query management, database lock, manuscript preparation, Journal submission and Publication management.Ensure accuracy, quality, and integrity of clinical data in accordance with regulatory standards.Coordinate with biostatistics, medical affairs, and external vendors for timely completion of data management activities.Review and analyze clinical study data and generate reports for decision-making and regulatory submissions.Support product registrations, renewals, variations, and post-approval submissions across international markets, marketing claims, particularly African countries.Prepare, review, and compile dossiers in CTD/eCTD formats as per country-specific requirements.Coordinate with local regulatory teams, distributors, and health authorities for submission and approval processes.Monitor changes in international regulatory guidelines and assess their impact on the business.Provide regulatory strategy support for new product introductions and lifecycle management.Work closely with the Head of Medical Affairs, Quality, R&D, Supply Chain, and Commercial teams to ensure timely regulatory approvals and clinical deliverables.Support due diligence, product evaluations, and technical assessments for international business opportunities.PV management and Support: PSUR, RMP, SMPC, etcDrive process improvements and maintain regulatory and clinical compliance documentation.
Role Description – Associate Manager – Medical Affairs
Essential Skills, Experience & Education
Educational Qualification: B.Pharm/M.Pharm/Pharm.D/BDS/MDS, MBBS, BAMS.Experience (4 – 8 years) Pharmaceutical/Healthcare companies with experience in Clinical Trial Management, Clinical Data Management (CDM).Exposure to international regulatory environments, preferably African markets (added merit)Good understanding of ICH-GCP, CTD/eCTD submissions, pharmacovigilance requirement.Experience in managing external stakeholders, CROs, and regulatory agenciesStrong analytical, project management, and communication skills.Proficiency in MS Office and clinical/regulatory documentation systemsSelf-starter with an ability to stay independently motivated and deliver the assigned mandate.Clinical Research & Data Interpretation.Effective Communication and Cross-Cultural Collaboration.Excellent communication, interpersonal and analytical skillsAbility to manage multiple projects and work in a fast-paced international environment
Application
If this role is of interest to you, please upload a recent copy of your CV and a member of the Talent Acquisition team will be in touch. We believe that equal opportunities mean inclusion, diversity and fair treatment for all.
Click on Apply to know more.