Associate Regulatory Affairs - External Manufacturing (Fixed Term Contract)

We seek to hire an Associate Regulatory Affairs to support our North America business. This role will be based in person in Hyderabad and is an 8-month temporary assignment to provide maternity leave coverage. The incumbent will 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

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.

Equal Opportunity Employer
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability.

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