Job Description

Vacancy for Regulatory Affairs at Roche 2023.

Organization	Roche
Post Name	Regulatory Affairs
Job Location	India
Official Website	https://www.roche.com/

Job Title/Position:

Regulatory Affairs – India & Direct markets (Sri Lanka, Nepal and Bhutan)

Job Overview:

Job vacancy for Pharmacy, Life Sciences

Job Location:

India

What are the Key Responsibilities?

Strategy / Planning :

Define regulatory strategy in co-ordination with global/local teams for early launch of new and subsequent new drugs in India as per the business needs. Collaborate with medical value, clinical, marketing, strategy, supply chain team for developing the regulatory strategy for new products.
Strategic thinking & strategic analysis including competition to identify changing trends for future Roche submission for positive outcomes
Oversee the execution of the strategy by team to submit and seek the approvals as planned with stakeholder mapping and engagement
Ensure regulatory compliance for product released to market according to marketing authorizations
Ensure effective Regulatory Affairs input into cross-functional Affiliate business strategies (e.g. market access, medical affairs, promotional activities, public policy, technical assessments, technical agreements, local manufacturing/packaging activities, legal issues, etc.)
Ensure regulatory inspection-readiness for the Affiliate, as per assigned responsibilities.
Gather, analyze and communicate internal and external regulatory intelligence
Develop innovative, risk-based registration plans and submissions strategies for Affiliate products with limited guidance from DRA Management
Keep a track on the development activities of competitors and communicate to the relevant departments of Affiliate on real time basis
Ensure compliance to internal and global systems (IFTs and trackers)
Update all internal local as well as global stakeholders on regulatory framework changes; Create procedures, trackers to facilitate working of team members; Allocate tasks within the team and provide leadership and director to team
Interactions and engagement with Regional / Global colleagues and Distributors of Direct markets

Dossier preparation, review and submission

Oversee timely and accurate submission of the applications to regulatory authorities as per the plan created; Liaise with regulatory authorities for seeking clarifications in case required;
Proactively take steps/drive discussions on open issues with cross functional teams for obtaining the approvals as per the timelines that are projected;
Follow up with team to respond to the queries in reasonable period of avoid delays in approvals
Ensure robust and effective preparation for HA meetings (SEC)

Life Cycle management

Follow up with team for submission of documents for license renewal; Review and give inputs during the preparation of submission, Check all variations are filed in timely manner to avoid any supply chain issues

Liaising with regulatory authorities

Routine interactions with regulatory authorities for getting feedback, follow-up, resolving open queries, gather intelligence for effective planning and faster approvals
Work for effective Roche India image

Policy shaping

Work with Industry associations for new reforms / policy shaping
Work with regulators for Policy shaping – ease of business, faster access, generics / biosimilar
Work with Regional and Global Regulatory policy team to drive the policy shaping in India
Work with Indian Pharmacopeia Commission for products entering IP

People development

Participate in recruitment and induction of new employees in team
Set objective goals and evaluate performance of team members
Ensure appropriate Regulatory Affairs resources and budget are in place
Recommend employees for promotions; Recommend reward and recognition programs for team
Provide performance feedback, conduct development activities, 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; Identify and recommend retention plans for key team members

What are the Educational Qualification(s) for Regulatory Affairs?

M.Pharm or equivalent degree, Higher degree and / or RA specialist accreditation desirable

What is the Experience Required for this Job?

Work Experience in years overall: 15+ years; Work experience relevant to the field: 10+ years
For internal hiring minimum 2 years with Roche Pharma

What are the Preferred Skills required for this Job/Position?

Pharmaceutical medicine training highly desirable
Knowledge of drug developments
Knowledge of clinical trials
Knowledge of manufacturing sites
Knowledge of regulatory and statutory requirements
Product knowledge
Knowledge of GMP
Knowledge of Quality Assurance

Related:

Detailed notice

https://careers.roche.com/global/en/job/202307-116681

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