Skip to main content

Career Opportunities at Merck as Manager in Regulatory Affairs

 

Clinical courses

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
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)

GO TO NEXT PAGE FOR MORE INFO...

Subscribe to Pharmatutor Job Alerts by Email

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

Additional Information:
Experience: 8-15 years
Location: Mumbai, India
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area:
Regulatory affairs

APPLY THROUGH RECRUITERS WEBSITE

See All   Merck Jobs   M.Sc Alerts   M.Pharm Alerts   Delhi Alerts

See All   Other Jobs in our Database

PharmaTutor Placements

Subscribe to Pharmatutor Job Alerts by Email