Job as Manager - Regulatory Affairs at Roche

Roche, 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity, and on seeing each other’s differences as an advantage. To innovate healthcare, Roche has ambitious plans to keep learning and growing – and is seeking people who have the same goals for themselves.

Post : Manager - Regulatory Affairs

Job Description:
To execute the regulatory strategy by providing guidance to the team for dossier preparation, ensuring timely submission of dossiers, respond to queries from regulatory authorities and keeping one’s self updated with changes to the regulatory environment With the objective of ensuring that the organization obtains approvals and licenses in a timely manner

Regulatory Plan Creation:
Collaborate with global teams during early stages of product development; Share inputs on regulatory requirements in the country from development and data perspective;
Understand timelines of availability of various documents for filing the application and the supply chain of the new product for which regulatory strategy being created;
Create regulatory strategy for the products assigned and share the same with the manager

Dossier preparation, review and submission:
Request documents from global and local teams for filing the application well in advance; Co-ordinate with team members for accurate collation of the documents for filing the application; Proactively, work with the liaison person to track the submission; Understand likely queries and keep documents ready in advance to either share the same to prevent the query or to have short lead time in submitting the response

Lifecycle Management:
Review and maintain the trackers for registration certificates, import licenses, post marketing commitment, package insert submission so as to facilitate timely submission of the applications as well as for maintaining regulatory compliance at high level; Plan renewal filing well in advance to avoid any delays in submission due to non availability of the documents; Evaluate and submit variations in a timely manner

Regulatory Environment updates:
Keep a track on the development activities of competitors and communicate to the team members on real time basis

People Management:
Set objective goals and evaluate performance of team members; Recommend for promotions; Recommend recognition programs for team; Coach and mentor the team; Provide opportunities to the team to develop their capabilities; Conduct regular team meetings to guide team on departmental issues; Resolve issues faced by team

Functional Competencies
Roche high performance competencies
Decision making
Influencing /persuasion skills
Driving collaboration and team work
Technical knowledge
Organization and planning skills
Negotiating skills
Communication Skills
Presentation Skills
Proven ability to interact well in a multifunctional team setting
Accuracy and attention to detail

Behavioral Competencies
Strategic Agility
Achieving results
Team work and Collaboration
Inspiring and Influencing
Interpersonal Skills
Adaptability
Patient centricity in decision making
Feedback and coaching.

Additional Information
Location : Maharashtra, Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Medical Affairs
End Date : 26th January, 2019