Merck Limited (formerly E. Merck Limited) was set up in India as the first Merck subsidiary in Asia in 1967. The Company operates both its Pharmaceuticals and Chemicals businesses in the country.
Merck was also the first Merck Group Company to go public in the year 1981. The Merck Group now holds 51% of the share capital in Merck Limited, while the remaining 49% is traded on the Bombay Stock Exchange Ltd. and National Stock Exchange of India Ltd. Merck Specialities Pvt. Ltd., the wholly owned Indian subsidiary of Merck KGaA, was incorporated in 2005.
Post : Manager - Regulatory Affairs
Job Description:
• Responsible for all regulatory activities in India & other semi regulated countries (Bangladesh, Srilanka, Nepal, Maldives etc.) to ensure product compliance
• Responsible for drafting all health authority communications and applications
• Ensure compilation of regulatory dossiers and resolve queries
• Coordinate, compile all post approval dossiers - Renewal, quality & safety updates for assigned countries.
• Follow-ups with country specific partners, third party network of consultants to maximize flexibility and broaden administrative & technical reach
• Design, review and collaborate for promotional material & artworks as and when required
• Support approvals/Licensing activities & ensure all approvals are obtained from relevant regulatory agencies on time
• Ensure customs clearances of ingredients/products from regulatory perspective.
• Lead all proactive regulatory and lobbying strategies, risk assessments and approaches in partnership with Head – Technical, Corporate Regulatory Policy Influence group, R&D staff to protect and expand product access within the market
• Partnering closely with counterparts in Regulatory Affairs, Product Development, Marketing, Legal teams to ensure Regulatory Policy and Influence strategies/activities are aligned with Corporate/Affiliate business plans
• Responsible for regular updates (Regulatory Database Management) in the established system
Candidate Profile
Experience
• University degree in Pharmaceutical Science, Chemistry, Food Industry
• 8-15 years in experience in similar domain
• Experience in the following industries: Pharmaceutical, OTC, food supplement area and FMCGs
Technical Expertise
• IT Tools: MS Office tools, Project Management tools, Portfolio Management Tools
• Well verse with Regulatory norms for NPD Pharmaceutical, OTC or Food supplement area
• RIMS (Regulatory Info.Mgmt.System)
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Soft Skills
• Fluent Business Communication
• Active listener
• Result & Customer orientation
• Innovative mindset
• Can-do attitude
• Inter-cultural competency
• Proactive Thinker
• Result and timeline driven
• Problem solver
Key Interfaces
Internal
• Asia R&D and Operations
Innovation Function – NPD, Project managers, Technical manager
• Commercial units within region
• Business Development, M&A teams
• (Regional management and Strategic marketing)
• Supply chain & Warehouses
External
• Health Authorities
• Industrial and governmental associations
• Manufacturing partners
Additional Information:
Experience: 8-15 years
Location: Mumbai, India
Education: B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Regulatory Affairs
Job ID: 169977
End Date: 2nd January, 2018
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