Hetero Biopharma, a leading biopharmaceutical company and division of the renowned Hetero Group, is seeking a highly motivated and experienced Regulatory Affairs Specialist to join our team in Hyderabad, India. Established in 2009, Hetero Biopharma is a global leader in the development and manufacturing of biosimilars, monoclonal antibodies (mAbs), recombinant proteins, vaccines, cell and gene therapies, and small molecule products. We are committed to delivering high-quality, affordable biologics to patients worldwide, making a tangible difference in global healthcare. This is an exceptional opportunity to contribute to a dynamic and rapidly growing organization at the forefront of biopharmaceutical innovation.
About Hetero Biopharma
Hetero Biopharma is a dynamic and rapidly expanding division of the Hetero Group, a multinational pharmaceutical company with a global presence. We are dedicated to improving global health by developing and manufacturing cutting-edge biopharmaceutical products. Our commitment to innovation and accessibility drives us to create solutions that address critical unmet medical needs across various therapeutic areas. Our comprehensive portfolio includes:
- Biosimilars: Offering cost-effective alternatives to expensive biologics.
- Monoclonal Antibodies (mAbs): Developing targeted therapies for a range of diseases.
- Recombinant Proteins: Producing vital proteins for therapeutic applications.
- Vaccines: Contributing to global immunization efforts.
- Cell and Gene Therapies: Pioneering advanced therapeutic modalities.
- Small Molecule Products: Expanding our reach into diverse therapeutic areas.
Our dedication to quality and compliance ensures that our products meet the highest international standards. We are committed to fostering a collaborative and inclusive work environment where innovation and professional growth are actively encouraged.
Job Description: Regulatory Affairs Specialist – API
We are seeking a detail-oriented and experienced Regulatory Affairs Specialist to join our API (Active Pharmaceutical Ingredient) team. This crucial role will involve managing and executing regulatory strategies for our API products in global markets. The successful candidate will be responsible for ensuring full compliance with international regulations and guidelines.
Key Responsibilities:
- Global Regulatory Dossier Preparation and Submission: Compile and submit comprehensive regulatory dossiers for API products to various global regulatory authorities, including but not limited to the US FDA, EMA (European Medicines Agency), Brazil’s ANVISA, China’s NMPA, and other LATAM and ICH regions. This includes preparation of Drug Master Files (DMFs) and Certificates of Suitability (CEPs).
- Regulatory Compliance and Strategy: Maintain a comprehensive understanding of evolving global regulatory requirements for APIs and proactively implement necessary changes in our documentation and processes. This includes staying abreast of new guidelines, amendments, and emerging market standards.
- Regulatory Filings and Amendments: Manage the entire lifecycle of regulatory filings, including initial submissions, annual updates, and amendments to existing submissions. This involves close collaboration with internal stakeholders across various departments.
- Deficiency Response and Management: Actively participate in deficiency meetings with regulatory agencies, review pending deficiencies, and collaborate with cross-functional teams to ensure timely and accurate responses.
- Document Review and Compliance: Thoroughly review all relevant regulatory documents to identify any gaps, ensure compliance with current guidelines, and facilitate acceptance meetings with regulatory authorities.
- Project Management and Evaluation: Manage and evaluate multiple international regulatory projects simultaneously, ensuring alignment with company goals and timelines.
- Process Improvement: Contribute to the continuous improvement of regulatory procedures and documentation practices, identifying opportunities for efficiency and enhanced compliance.
Qualifications and Experience:
- Education: M.Sc. (Organic Chemistry) / M.Pharm (Pharmaceuticals) / B.Pharm (Pharmaceuticals)
- Experience: 2-8 years of proven experience in Regulatory Affairs within the API industry is essential.
- Regulatory Expertise: Strong understanding of US, EU, and ICH regulatory guidelines is paramount. Experience with DMF and CEP compilation, amendments, and annual reporting is a must.
- Technical Skills: Proficiency in relevant software and databases used in regulatory submissions.
- Communication and Collaboration: Excellent communication, interpersonal, and teamwork skills are necessary for effective collaboration with internal and external stakeholders.
- Attention to Detail: Meticulous attention to detail and exceptional organizational skills are crucial for ensuring the accuracy and completeness of regulatory submissions.
- Problem-Solving: Ability to effectively identify and resolve complex regulatory issues.
How to Apply
Interested and qualified candidates are encouraged to submit their CVs to: prathap.p@hetero.com
