Associate Regulatory Affairs -External Manufacturing (NAG)

Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 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 started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries. 

For nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry evolves and undergoes disruption, we see an opportunity – to strengthen our core further (the next steps) and to build the future (the new bets).

‘The Next and the New’ is how we aim to continue to be the partner of choice – purpose-driven, future-ready and sustainable.  Our aim is to reach over 1.5 Bn+ patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy. Sustainability for us means operating in a manner that respects people, planet and purpose – helping us conserve precious resources, serve our patients, create value for stakeholders, give back to society, fulfil our potential and maintain our integrity and transparency

Dr Reddy’s maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ & nurture all qualified diverse workforce without regard to race, colour religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization.

We are looking for an individual to carry out core regulatory activities including Authoring, compilation, and publishing of regulatory submissions and independently supporting the life cycle management activities for the externally manufactured products (Dr. Reddy’s and in-licensed products) and ensuring regulatory compliance and systems.

Responsibilities

• Authoring, compilation, and publishing of regulatory submissions inclusive of chemistry, manufacturing and controls supplements, new drug applications and generic drugs as assigned.
• Provide regulatory operational support for External Manufacturing operations including co-ordination with CMOs, obtaining required documents from different CMOs, change controls and master document reviews, regulatory submissions.
• Compilation of post approval Changes (Supplements PAS/CBE-30/CBE-0 & Annual Reports) for ANDAs managed by North America Generics (NAG).
• Authoring of Annual Reports of the drug products and submission within stipulated time frame.
• Assembles and maintains regulatory files of FDA communications.
• Providing regulatory input and support and as necessary for Cross Functional Teams for external products.
• Monitors and tracking of upcoming supplements and Annual Reports.
• Timely routine operational support to NAG External manufacturing -In licenses and out licensed products.
• Preparing Regulatory strategy notes, regulatory due diligence support and launch support for acquired products in consultation with team lead.
• Digitalization of external products.
• Need based publishing support to the team.
• Manage all GDUFA related submissions including fees, establishment registrations and self-identification, annual volume reporting etc.

Educational qualification: A Bachelor's/ Master’s degree in any of the life sciences. RAC is highly desired.

Minimum work experience: At least 4-6 years of generic pharmaceutical industry experience including 3-6 years of regulatory affairs experience.

Skills & attributes:

Technical Skills

• Hands on experience with CMC submissions, labelling activities and product launches.
• Good understanding of applicable 21 CFR regulations pertaining to marketing of drug products in US.
• Thorough understanding of regulatory guidelines of different countries, ICH guidelines, pharmacopeia's, product filing and approval requirements, Technical knowledge and regulatory requirements of different dosage forms.                                                                   

Behavioral skills

• Possesses strong communication skills, cultural sensitivity, and excellent interpersonal skills.
• Pays meticulous attention to details in tasks and responsibilities.
• Ability to understand and communicate with CFTS and CMOs.
• Demonstrates a commitment to continuous learning and staying updated on the latest regulatory expectations.
• Ensure appropriate maintenance of regulatory document files

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/#!/