Department: Regulatory Affairs

Designation: Manager – Regulatory

Job Location: Palghar (Near to Mumbai)

Experience: 5+ years of experience in Regulatory

Job Summary: Procuring raw materials, packaging materials, and other supplies needed for production and operations. This includes sourcing suppliers, negotiating contracts, managing inventory and ensuring compliance with regulatory standards like GMP.

Responsibilities:

Regulatory Strategy and Submissions: Develop and implement regulatory strategies for new and existing products. This includes preparing, submitting, and managing product registration dossiers, notifications, and applications to various regulatory bodies. The manager must stay informed on the latest regulations to advise on product formulations, claims, and labelling to ensure market entry and continued compliance.

Documentation and Compliance: A core duty is maintaining meticulous records. The manager oversees the creation and maintenance of technical files, safety dossiers, and other documentation required for product registrations. They are responsible for ensuring ongoing compliance with Good Manufacturing Practices (GMP), labelling requirements, and advertising standards.

Cross-Functional Collaboration: The regulatory manager works closely with various departments, including Research & Development (R&D), Quality Assurance, Marketing, and Legal. They provide regulatory guidance throughout the product lifecycle, from initial concept and formulation to marketing and post-market surveillance. For example, they advise the marketing team on permissible health claims and the R&D team on ingredient compliance.

Liaison with Regulatory Agencies: They serve as the main point of contact for regulatory authorities. This includes responding to inquiries, addressing deficiencies, and negotiating with agencies to expedite product approvals. They also represent the company at industry forums and consultations.

Audits and Inspections: The manager prepares for and manages internal and external audits by regulatory bodies or third-party certifiers. They ensure all facilities, processes, and documentation are inspection-ready at all times.

Regulatory Intelligence and Risk Management: They proactively monitor the global regulatory landscape, including new and proposed legislation, guidelines, and industry trends. They then assess the potential impact of these changes on the company's product portfolio and develop risk mitigation strategies.

Preparation and filing of new drug applications (NDA), for submission to regulatory authorities.

Liaise with CDSCO, State FDA, DCGI, and port offices for various regulatory submissions and approvals.

Ensure product labels and artworks comply with D&C Rules, FSSAI (if nutraceuticals), and other applicable standards.

Essential Qualifications and Skills

Education: A bachelor's or master's degree in a relevant field such as Regulatory Affairs, Food Science, Nutrition, Chemistry, or Pharmaceutical Sciences is typically required.

Experience: Significant experience (usually 5-10 years) in a regulatory capacity within the health, nutrition, food industry or Pharma is crucial.

Knowledge: Deep understanding of key regulations and frameworks such as the Dietary Supplement Health and Education Act (DSHEA) and Food Safety Modernization Act (FSMA) in the U.S., RDA Limits, FSSAI & FDA knowledge as well as international regulations (e.g., EU, ASEAN, GCC, NAFDAC).

Discovery and Early Development of new product: RA professionals are involved from the very beginning. They provide regulatory intelligence by advising R&D on which ingredients, technologies, or formulations are compliant with regulations in target markets. This early guidance helps prevent costly delays or product redesigns later on. They also help define the target product profile to ensure it aligns with regulatory pathways.

Pre-Clinical and Clinical Development of new product: During this phase, RA is the primary link between the company and regulatory agencies. They are responsible for preparing and submitting all necessary applications, such as Investigational New Drug (IND) applications for pharmaceuticals, to get approval for human trials. They ensure that all studies are conducted in accordance with Good Clinical Practice (GCP) and other relevant guidelines.

Submission and Approval: This is the most visible role of RA. The team compiles and manages the massive amounts of data from R&D, manufacturing, and clinical trials into a single, comprehensive submission dossier (e.g., a New Drug Application (NDA) or Biologics License Application (BLA)). They then submit this to the relevant regulatory authorities and manage all communication, questions, and negotiations until marketing authorization is granted.

Post-Market Management: The work of RA doesn't end with product approval. They are responsible for lifecycle management, which involves:

Change Control: Managing regulatory submissions for any changes to the product, such as manufacturing process updates, new indications, or formula changes.

Compliance: Ensuring all product labels, advertising, and promotional materials meet regulatory standards.

Reporting: Submitting periodic safety updates and reports to health authorities.

Recalls: Coordinating with regulatory bodies in the event of a product recall.

Essentially, regulatory affairs professionals are the guardians of a product's compliance, strategically guiding its development to minimize risk and maximize the chance of a successful market entry and sustained commercial viability

Skills: Strong analytical, communication (written and oral), and project management skills are essential. Attention to detail is paramount, as is the ability to interpret complex regulations and translate them into actionable business strategies.

Qualifications:

• Bachelor's / Master’s degree in Chemistry / BE in Chemicals or equivalent