Emcure hiring Regulatory Affairs

M.Pharm/M.Sc Regulatory Affairs (Brazil) – Ahmedabad

M.Pharm/M.Sc | 1 Vacancy | Regulatory Affairs (Brazil Market) – Ahmedabad. 8–15 yrs experience with ANVISA product registration expertise.

Experienced regulatory affairs professionals with Brazil/ANVISA expertise are rare and in high demand. Emcure is seeking a seasoned Regulatory Affairs Executive to Manager to own ANVISA-facing submissions, lifecycle management, and cross-functional strategy for products destined for the Brazilian market. This role demands hands-on submission experience, a deep understanding of Brazilian regulatory frameworks, and the ability to translate global regulatory strategy into compliant local dossiers. If you hold an M.Pharm or M.Sc and have 8–15 years in regulatory operations for emerging markets, this Ahmedabad-based opportunity offers strategic exposure and leadership potential.

Company Overview

Emcure Pharmaceuticals is a recognized leader in global pharmaceutical manufacturing and commercialization. The company focuses on research-driven product development, regulatory compliance, and supplying essential medicines across regulated and emerging markets. Emcure combines strong manufacturing capabilities with global regulatory experience, making it a suitable platform for professionals aiming to deepen their expertise in international regulatory affairs.

Emcure’s regulatory teams partner with R&D, QA/RA, Clinical, and Commercial functions to secure and maintain product approvals worldwide. The company’s focus on compliance, structured regulatory strategy, and continuous process improvement positions it well for specialists targeting high-value markets such as Brazil.

Role: Regulatory Affairs (Brazil Market) — Executive to Manager

What this role owns

This position is responsible for end-to-end regulatory management for products in the Brazilian market, working closely with global and local stakeholders. The role will handle submissions to ANVISA (Agência Nacional de Vigilância Sanitária), coordinate responses to regulatory queries, and ensure post-approval compliance across the product lifecycle.

Key Responsibilities

• Lead and prepare ANVISA dossier submissions for product registration, renewals, variations, and post-approval changes.
• Interpret Brazil-specific regulatory requirements and map global dossiers to local submission formats.
• Draft and review regulatory documents including CTD modules, administrative forms, technical summaries, and regulatory cover letters.
• Coordinate with cross-functional teams (CMC, Quality, Clinical, Pharmacovigilance, Legal, and Commercial) to gather data and ensure dossier completeness.
• Manage timelines, submission trackers, and maintain regulatory intelligence on ANVISA guidance, circulars, and regulatory changes.
• Respond to ANVISA queries and deficiency letters, preparing technically robust responses with supporting data and scientific rationale.
• Drive dossier readiness audits and ensure compliance with local labeling, packaging, and pharmacovigilance requirements.
• Support inspections and regulatory audits related to Brazilian market-authorised products.
• Mentor junior RA staff and build internal capability for Brazil-specific regulatory practices.

Why this role matters

Brazil is one of the largest pharmaceutical markets in Latin America and has unique regulatory pathways that directly affect market access. A dedicated specialist ensures timely approvals, mitigates regulatory risk, and aligns product strategy with local requirements—speed to market and sustained compliance both depend on this role.

Eligibility / Qualifications

• Education: M.Pharm or M.Sc in Pharmacy, Pharmaceutical Sciences, Biotechnology, or related life sciences discipline.
• Experience: 8–15 years in regulatory affairs with demonstrable experience in ANVISA submissions, dossier preparation, and regulatory strategy for Brazil.
• Strong knowledge of CTD structure and local dossier requirements for Brazil.
• Proven ability to manage end-to-end regulatory submissions and interact with local agents, notified bodies, and regulatory consultants, if required.
• Excellent technical writing skills with the ability to prepare robust scientific justifications and responses to regulatory queries.
• Cross-functional collaboration skills; experience working with CMC, QA, clinical operations, and pharmacovigilance teams.
• Fluency in English; Portuguese language skills are a strong advantage but not mandatory (experience of working with Portuguese-language dossiers or translators is beneficial).
• Proficiency with regulatory tracking systems, submission management tools, and MS Office.
• Strong project management, prioritization, and stakeholder communication skills.

Relevant courses: M.Pharm (Regulatory Affairs), M.Pharm (Pharmaceutics), M.Sc Pharmaceutical Sciences, M.Sc Biotechnology, M.Sc Biochemistry, PG Diploma in Regulatory Affairs, MBA Pharma.

Location & Salary

• Location: Ahmedabad, Gujarat, India
• Salary: Competitive and commensurate with experience (aligned to industry standards for senior regulatory roles). Exact CTC will be discussed during the interview process.

Application Process

Interested candidates should send their detailed CV to bhavik.parekh@emcure.com with the subject line:

Application – Regulatory Affairs (Brazil Market) – Ahmedabad

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How to prepare your application (quick checklist)

• Include a concise cover letter (1 page) summarizing ANVISA experience and notable submissions.
• Attach a dossier highlights document (if permissible) or provide anonymized case studies of submissions you contributed to.
• List direct experience with Brazilian regulatory timelines and any Portuguese-language involvement.
• Provide references or contact details for senior stakeholders who can validate submission ownership.

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FAQs

Q: Is Portuguese mandatory for this role?
A: No. Portuguese is not mandatory, but practical experience with Portuguese-language dossiers or working with translators/local agents is highly valued.

Q: Will I need to relocate to Ahmedabad?
A: Yes. This role is based in Ahmedabad. Remote work may be limited due to cross-functional coordination and local regulatory interactions.

Q: What level of ANVISA exposure is required?
A: Candidates should have direct experience with ANVISA submissions—product registrations, renewals, variations, or post-approval changes—and be comfortable preparing CTD-based dossiers mapped to Brazilian requirements.

Q: Is the role more technical or strategic?
A: It blends both. Expect hands-on dossier preparation and technical query responses, alongside strategic input on regulatory pathways and lifecycle planning.

Q: What is the interview process?
A: Initial CV screening, technical assessment with case questions, and a final panel interview with RA leadership and cross-functional stakeholders.

Category	Details
Company	Emcure Pharmaceuticals
Vacancies	1 (Regulatory Affairs – Brazil Market)
Required Education	M.Pharm, M.Sc (Pharmaceutical Sciences, Biotechnology, Biochemistry), PG Diploma Regulatory Affairs
Experience	8–15 years (ANVISA/ Brazil regulatory submissions)