Job Description

The Position

Accountabilities

Regulatory Affairs \xe2\x80\x93 India & Direct markets (Sri Lanka, Nepal and Bhutan)

• 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

Internal Stakeholders

Value Enabling Team (VET), Value Teams, Access & Rare diseases partner, Supply Chain, Quality Unit, Compliance Team, Legal, Portfolio Prioritization Committee, Launch Excellence community, global and regional RA team, Regulatory policy team, Other departments of Medical

External Stakeholders

RA - Regulatory Bodies, Government \xe2\x80\x93 MOH officials, Business partners; Service providers, patients groups, Industry Bodies, Policy Makers

Functional Competencies

Knowledge of healthcare landscape, People management , Regulations area knowledge, Technical expertise in the field of RA, Working knowledge of QA, clinical operations, drug safety and medical, Change management

Behavioral Competencies

Exhibition of Roche Leadership Commitments and Roche Core Values, Exhibition of Servant Leadership and VACC Leadership (Visionary, Architect, Coach, Catalyst), Patient centricity in decision making, Strong Collaboration and Networking skills, Inspiring and Influencing, Negotiating Skills, Accuracy and attention to detail, Multi-tasking

Eligibility Criteria (Qualification and Experience)

• Qualifications: M. Pharm or equivalent degree, Higher degree and / or RA specialist accreditation desirable
• Experience: Work Experience in years overall: 15+ years; Work experience relevant to the field: 10+ years
• For internal hiring minimum 2 years with Roche Pharma
• Knowledge

• 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

Job Location: Mumbai (HO) or Delhi

Roche Leadership Commitments (RLCs)

• I take a genuine interest in people.
• I listen carefully, tell the truth, and explain "the why".
• I empower and trust people to make decisions.
• I discover and develop the potential in people.
• I strive for excellence and extraordinary results.
• I set priorities and simplify work.
• I congratulate people for a job well done.

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we\xe2\x80\x99ve become one of the world\xe2\x80\x99s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an Equal Opportunity Employer.

Roche