Company Description

Dr. Reddy’s Laboratories, or Dr. Reddy’s in short, is a global integrated pharmaceutical company.

Each of our 20,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can’t Wait. We believe that the game-changing power of technology is what will help us deliver on this purpose. Our digital transformation journey is continuous, pervasive and driven at the highest level.

We are looking for people who share our passion to catalyze this journey.

A brief about us (you’ll find more on our website www.drreddys.com): We have three core businesses: Global Generics, Pharmaceutical Services and Active Ingredients and Proprietary Products. We have a strong and growing Biologics portfolio and a rich, transnational R&D network. Our manufacturing, marketing and sales operations span 56 countries.

Job Description

Position title:

Head of Regulatory Affairs and Quality Assurance

Country:

Vietnam

Function:

Regulatory Affair

Reporting line:

Country Head

Matrix reporting line:

Head of Regulatory- EM& India

Position: Head of Regulatory Affairs and Quality Assurance

Purpose

To: Lead the Regulatory team in Vietnam to develop strategic plan and execute the agreed strategy to deliver business goals. Liaison with officials at DAV (Drug Administration of Vietnam); review, sign-off and submit registrations, deficiency responses, post-approval changes, safety, labelling and annual updates to DAV in the stipulated timelines and in the required format; handle regulatory related matters, provide inputs on regulatory requirements to business and development teams; provide direction and support to regulatory team members.

Within:  regulatory requirements and broad organizational guidelines

With the objective of ensuring timely filing and approval of all regulatory documentation required for smooth conduct of business operations in Vietnam.

Areas of responsibility

• Responsible for long- and short-term planning and directing of regulatory activities. Interprets corporate policy, develops and implements strategies for the earliest possible approval of regulatory submission, advises and manages the regulatory teams, and reviews ongoing projects.
• Plans, schedules and directs activities and programs through regulatory staff.
• Work with both internal and external stakeholders, outside agencies (national and international) as needed to resolve key regulatory issues and expedite approvals of product and services.
• Coordinate and/or represent the Company in meetings with government officials, administrators, regulators and business associations. Establish networks with senior level authorities in DAV and key stakeholders to provide information and explanations on business policies and practices, seek their support during major issues and provide them explanations and information IN ORDER TO ensure healthy relations with regulatory authorities to enable timely approvals of registration and manage related regulatory issues effectively.
• Develop and execute a strategy and stakeholder engagement plan to accomplish these objectives.
• Reviews and prepares responses to inquiries from regulatory authorities relating to product registrations.
• Oversees the preparation and submission of applications, responses to inquiries from regulatory authorities relating to product registration and other regulatory related matters.
• Coordinate with local partners and head office QA team to ensure QA related requirements and matters to be managed well with full compliance to local regulations and company policies and guidance.
• Manage routine reports/renewals, including the preparation and submission of supplements and amendments as required by internal department. (Manufacturing, QA/QC, Medical, etc.) to update registered product information.
• Understand existing and monitor evolving Government policies and legislation, determine their potential impacts on business, freedom to operate, or new opportunity.
• Monitors ongoing legislative and regulatory developments and updates local registration requirements through reviews of publications, seminars, and direct communication with outside regulatory personnel; provide timely analysis of their relevance to the business and management team.
• Communicates pertinent changes and updates to regulatory staff and senior management.
• Ensure all documents and operation in regulatory affairs to follow companies policies, procedures and comply to local laws and regulation.
• Co-ordinate with internal and external stakeholders and lead RA team to provide support and needful actions for audit purposes
• Develop Regulatory team to strengthen capability and competencies.

Job requirements Skills and attributes

• Technical skills:
• Solid knowledge of local pharmaceutical government policies and legislation
• Knowledge and competencies in managing regulatory affairs.
• Other skills:
• Very clear and systematic thinking that demonstrates strong judgment and
• problem-solving competencies
• Strategic thinking and leadership ability
• Excellent communication skills
• High analytic skill
• Highly organized and structured
• Negotiation, influencing advocacy skills
• Highly ability to interact with internal and external stakeholders.
• Highly ability to lead and motivate a team for optimum performance.

Experience

• Minimum 15 years’ regulatory experience in pharmaceutical industry.
• Established network and experience with regulatory authorities.
• Experience in leading and managing complex to deliver and maintain regulatory approvals.
• Proven track record in influencing and shaping optimal regulatory outcomes.
• Proven ability to work effectively in a team environment and matrix structure.
• Experience building and leading teams.

Education

Bachelor's degree or master's degree in pharmacy.

Other requirements:

• Fluency in English
• Sufficient knowledge and skills of Microsoft Suite

About the Department
Emerging Markets
Branded generics is one of our biggest businesses in Emerging market and our branded products are available 48 countries across 5 regions. Our key markets are Russia, China and Brazil. We also have presence in Latin America, Africa, Australia, New Zealand, ASEAN (Association of Southeast Asian Nations), CIS and Romania. We have added 13 new geographies in the last 5 years.
In the last 4 years, our emerging markets business’ growth rate has doubled (June ’22). Our diverse portfolio spans all segments. We are continuously advancing technologies, enhancing efficiency of operations and increasing our portfolio of highest-quality quality products.
With nearly 40 products and 6 mega brands, Russia is a key market. With more than 30 years of operations in the region, as of FY22, we have reported a year-on-year growth of 32%. This was driven by improved existing business performance, launch of new products during the year along with divestment of some non-core brands. 6 key products were ranked among the top 200 bestselling formulation brands, as per IQVIA in its report for the 12-month period ended 31 March, 2022. 5 of our leading products were voted as the ’Product of the Year’ by the consumers – reaffirming the trust that the people of Russia have in them.
We are among the earliest Indian pharma companies to have a business presence in China. We have a representative office that focuses on filings and approvals, including the Group Purchasing Organisation (GPO). Our joint venture entity (Kunshan Rotam Reddy Pharmaceutical Co. Ltd) offers a portfolio of niche and essential products, strengthening our presence in China.
In Latin America we have a strong presence in Brazil and Colombia. In just a little over five years in Brazil, our team has established itself in the region with our diverse portfolio. Our primary focus in Brazil is oncology and institutional. Our team in Colombia was certified as a ‘Great Place to Work’.
Through our comprehensive COVID-19 portfolio, we were able to reach over 5 million patients in low and middle-income countries. With the aim of reaching more and more patients around the world, we are harnessing our deep science capabilities to create a robust portfolio in the region to become the partner of choice.
Our teams in China, Brazil, Colombia and Thailand, Malaysia are a certified great place to work. Our team in Russia is among the top 3 in Head-hunter’s Best Employer Ranking in 2022. These recognitions reaffirm our commitment and efforts to bring science, technology and innovation together to offer affordable medicines and solutions beyond the pill to patients in the region.
As the need, scope and standards of healthcare evolve, we keep track of emerging needs to contribute to patient welfare. After all, Good Health Can’t Wait

Benefits Offered
At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself.

Our Work Culture
Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic.
For more details, please visit our career website at https://careers.drreddys.com/#!/